Datasets:

TrialPanorama
/

Dataset

id int64 0 4.64k	task_type stringclasses 1 value	instruction_prompt stringclasses 1 value	question stringlengths 362 64.9k	answer stringclasses 5 values
0	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What are the effects of using absorbable synthetic suture material compared to catgut for perineal repair in terms of short-term pain, need for analgesia, suture dehiscence, and long-term pain? Please answer this question based on the information provided below: [A comparison between chromic catgut and polyglycolic acid sutures in episiotomy repair (author's transl)]. Polyglycolic acid sutures (Dexon) were compared to chromic catgut sutures in episiotomy repair. When polyglycolic acid sutures were used, the degree of postpartum perineal pain was approximately half as great, and the incidence of dehiscence of episiotomy was 3--5 times greater in the chromic catgut group. The cosmetic results 3 months postpartum were clearly better by using Dexon sutures, especially when the perineal skin was closed by a continuous intracutaneous suture. A trial of polyglycolic acid and chromic catgut sutures in episiotomy repair. A comparison between catgut and polyglycolic acid sutures in episiotomy repair. The Ipswich Childbirth Study: 2. A randomised comparison of polyglactin 910 with chromic catgut for postpartum perineal repair. OBJECTIVE: To compare polyglactin 910 sutures with chromic catgut sutures for postpartum perineal repair. DESIGN: A stratified randomised controlled trial, using a 2 x 2 factorial design. SETTING: The maternity unit at Ipswich Hospital NHS Trust, a district general hospital, between 1992 and 1994. SAMPLE: 1780 women who had sustained an episiotomy or first or second degree tear following a spontaneous or simple instrumental delivery. METHODS: Policies of repair with polyglactin 910 or chromic catgut were compared. Both groups were assessed by a research midwife completing questionnaires at 24 to 48 hours and at ten days postpartum, and by self-completed questionnaires at three months after birth. MAIN OUTCOME MEASURES: 1. 24 to 48 hours postpartum: perineal pain, healing; 2. ten days postpartum: perineal pain, healing and removal of sutures; 3. three months postpartum: perineal pain, removal of sutures, resuturing, dyspareunia, and failure to resume pain-free intercourse. RESULTS: Completed questionnaires were returned for 99% of women at both 24 to 48 hours and ten days and by 93% of women three months postpartum. The two groups were similar at trial entry. Significantly fewer women allocated to the polyglactin 910 reported pain in the previous 24 hours at both 24 to 48 hours (59% vs 67%; RR 0.89, 95% CI 0.83-0.95; 2P < 0.01), and ten days (24% vs 29%; RR 0.81, 95% CI 0.69-0.95; 2P = 0.01). At three months postpartum there was no clear difference between the groups in terms of perineal pain, dyspareunia or failure to resume pain-free intercourse. More women in the polyglactin 910 group reported that some suture material had been removed (12% vs 7%; RR 1.62, 95% CI 1.19-2.21; 2P < 0.01). Three women in the polyglactin 910 group had required resuturing compared with ten in the chromic catgut group (RR 0.30; 95% CI 0.08-1.09; 2P = 0.1). CONCLUSIONS: Using polyglactin 910 rather than chromic catgut for perineal repair leads to about one fewer women among every 20 having perineal pain and using analgesia ten days postpartum. Its only apparent disadvantage is that more women, again estimated as 1 in 20, report having material removed during healing. Data from this and other trials suggest that for every 100 women repaired with a polyglycolic acid-based material, about one fewer will require resuturing. The Southmead perineal suture study. A randomized comparison of suture materials and suturing techniques for repair of perineal trauma. Commonly used suture materials and techniques for perineal repair following vaginal delivery were compared in a randomized controlled trial involving 1574 women. Three comparisons were made using a modified factorial design. In the comparison of teflon-coated polyglycolic acid (Dexon plus) with chromic catgut for repair of the vagina and deep perineal tissues there was no clear difference other than less short-term analgesia being required in association with polyglycolic acid. Outcome was also similar after skin repair with either polyglycolic acid or chromic catgut or silk, although silk repair required more packets of material and was associated with delay in resuming sexual intercourse; polyglycolic acid was more likely to need removal than chromic catgut but it appeared to reduce the need for resuturing. There was no clear difference between continuous subcuticular and interrupted transcutaneous sutures for repair of perineal skin. Polyglycolic acid and catgut sutures, with and without oral proteolytic enzymes, in the healing of episiotomies. Polyglycolic acid (PGA) sutures and traditional catgut were compared in 190 patients undergoing episiotomy. Each group was also randomly allocated to a double blind comparison of therapy with oral proteolytic enzymes (Chymoral) and placebo. The combination of Chymoral and polyglycolic acid sutures was shown to reduce the level of pain, assessed subjectively, and there was a significant reduction in analgesic requirements in the Chymoral/PGA group. Evaluation of post-episiorrhaphy pain: polyglycolic acid vs catgut sutures. Options: A: Absorbable synthetic sutures result in less short-term pain, less need for analgesia, less suture dehiscence, and significantly less long-term pain. B: Absorbable synthetic sutures result in less short-term pain, less need for analgesia, less suture dehiscence, but no significant difference in long-term pain. C: Absorbable synthetic sutures result in more short-term pain, more need for analgesia, more suture dehiscence, and significantly more long-term pain. D: Absorbable synthetic sutures result in no difference in short-term pain, need for analgesia, suture dehiscence, or long-term pain.	B
1	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness of bed rest in hospital for women with suspected impaired fetal growth compared to ambulatory management? Please answer this question based on the information provided below: The effect of bedrest in hospital on fetal outcome in pregnancies complicated by intra-uterine growth retardation. A prospective study was made to evaluate whether bedrest in hospital is beneficial in pregnancies where intra-uterine growth retardation (IUGR) was suspected. Diagnosis was based on routine fetometry at 32 weeks of gestation, in conjunction with general ultrasound screening. 107 patients with suspected IUGR-pregnancies were divided into two groups, 49 in a hospital bedrest group and 58 in an 'out-patient' group. Fifteen women in the bedrest group refused hospitalization, and 8 women in the out-patient group had to be hospitalized for medical reasons other than suspected growth retardation, leaving 79% of the women in their allocated group. The women in the bedrest group were hospitalized for a mean duration of 29.2 days (range 5-54). The results suggest that bedrest in hospital is not beneficial, either to fetal growth or to pregnancy outcome. Options: A: Bed rest in hospital significantly improved fetal growth parameters and neonatal outcomes. B: Bed rest in hospital significantly worsened fetal growth parameters and neonatal outcomes. C: There were no significant differences in fetal growth parameters and neonatal outcomes between bed rest in hospital and ambulatory management. D: Bed rest in hospital was found to be harmful to both the mother and the fetus.	C
2	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness of betamimetic therapy for suspected impaired fetal growth in terms of fetal growth and perinatal outcomes? Please answer this question based on the information provided below: Long-term hospitalization and beta-mimetic therapy in the treatment of intrauterine growth retardation of unknown etiology. A group of 98 third trimester pregnant women whose ultrasonographic studies raised the suspicion of intrauterine fetal growth retardation was studied. The patients were randomly assigned to two groups: Group A (Treatment group: 44 patients) and Group B (Control group: 54 patients). All patients were admitted to the hospital upon diagnosis for baseline evaluation. Those in Group A remained in the hospital until delivery (mean stay 15 +/- 5 days) and received treatment with 10 mg/t.i.d. of p.o. ritodrine. Group B patients were discharged after an average stay of 7 +/- 3 days. This group was not treated with ritodrine, and they were seen weekly in an outpatient setting. The prevalence of low-birth-weight infants for their gestational age was 47.73% in the treatment group and 40.74% in the control group. Of the deliveries in the treatment group, 40.9% were induced (half for fetal indications). In the control group 35.18% of the induced labors was (47.35% for fetal indications). Of the cases in the treatment group 18.18% were delivered by cesarean section, of which 62.5% were performed for fetal distress. The control group showed similar figures: 16.66% cesarean sections with 77.7% of them done for fetal distress. We observed an incidence of 20.45% of acute fetal distress in the study group against 12.96% in the control group. Such a difference is not statistically significant. The group under study demonstrated a rate of 6.82% pathological pH value in the umbilical artery, while the rate of abnormal values in the control group was 18.52%. In both groups, the greatest percentage of acidotic pH was observed in patients with IGR.(ABSTRACT TRUNCATED AT 250 WORDS) Options: A: Betamimetic therapy significantly improved fetal growth and reduced neonatal morbidity and mortality. B: Betamimetic therapy had no significant effect on fetal growth, neonatal morbidity, or mortality. C: Betamimetic therapy significantly increased the risk of low birth weight and other adverse outcomes. D: Betamimetic therapy showed mixed results, with some studies indicating benefits and others indicating harm.	B
3	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the use of prophylactic betamimetic therapy during the second stage of labour on perinatal outcomes? Please answer this question based on the information provided below: The effect of intravenous ritodrine on the acid-base status of the fetus during the second stage of labour. A progressive fetal respiratory acidosis occurs in the second stage of labour. A double-blind controlled trial showed that the intravenous infusion of Ritodrine abolished this. Options: A: Prophylactic betamimetic therapy significantly reduced the need for forceps deliveries and improved neonatal outcomes. B: Prophylactic betamimetic therapy had no significant effect on the need for forceps deliveries, postpartum haemorrhage, neonatal irritability, feeding slowness, umbilical arterial pH values, or Apgar scores at 2 minutes. C: Prophylactic betamimetic therapy was associated with an increase in forceps deliveries and had no clear effects on postpartum haemorrhage, neonatal irritability, feeding slowness, umbilical arterial pH values, or Apgar scores at 2 minutes. D: Prophylactic betamimetic therapy significantly improved placental blood flow and fetal oxygenation, leading to better perinatal outcomes.	C
4	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness and tolerance of different antibiotics for treating genital Chlamydia trachomatis infection in pregnant women? Please answer this question based on the information provided below: Chlamydia in pregnancy: a randomized trial of azithromycin and erythromycin. OBJECTIVE: To determine side effect profiles and cure rates of azithromycin compared with erythromycin in the treatment of chlamydial cervicitis complicating pregnancy. METHODS: Pregnant patients with positive DNA antigen assays for Chlamydia trachomatis were randomized to either azithromycin, 1 g oral slurry in a single dose, or erythromycin, 500 mg every 6 hours for 7 days. Repeat assays were planned for 3 weeks after therapy. Side effects, compliance, and treatment efficacy were assessed. RESULTS: One hundred six women were enrolled, and eighty-five women completed the protocol. Significantly fewer gastrointestinal side effects were noted in the azithromycin group than in the erythromycin group (11.9% versus 58.1%, P < or = .01). Enhanced compliance was noted with azithromycin, because it was given in a single observed dose. Similar treatment efficacy was noted between azithromycin and erythromycin (88.1% versus 93.0%, P > .05). CONCLUSION: Compared with erythromycin, azithromycin is associated with significantly fewer gastrointestinal side effects in pregnancy. This association, along with the ease of administration and similar efficacy, suggests that azithromycin should be considered for the initial treatment of chlamydial cervicitis in pregnancy. Randomised comparison of amoxycillin and erythromycin in treatment of genital chlamydial infection in pregnancy. Erythromycin, the standard treatment for chlamydial infection in pregnant women, commonly causes side-effects, which limits its efficacy. In a randomised, double-blind study, we compared amoxycillin with erythromycin in this setting. 210 pregnant women with Chlamydia trachomatis infection were randomly assigned 7 days' treatment with amoxycillin (500 mg three times daily) or erythromycin (500 mg four times daily). Control cultures were obtained 21 days after treatment, during late pregnancy, and from the infant within a week of birth. Treatment was judged a failure if any post-treatment culture was positive or if the patient had to stop therapy because of severe side-effects. 11 women (5.2%) were lost to follow-up. 1 (of 100) amoxycillin-treated women had to stop treatment because of severe side-effects compared with 12 (of 99) erythromycin-treated women (p = 0.002). 1 woman in the amoxycillin group had a positive culture at the third-trimester examination. No positive post-treatment culture was found in the erythromycin group. Severe gastrointestinal side-effects were more common in women who received erythromycin (31 vs 6%, p < 0.001). The overall failure rate was therefore 2% in the amoxycillin group and 12% in the erythromycin group (p = 0.005). These results suggest that amoxycillin is an acceptable alternative to erythromycin for C trachomatis infection in pregnant women. Comparative efficacy of clindamycin versus erythromycin in eradication of antenatal Chlamydia trachomatis. Antenatal Chlamydia trachomatis infections are associated with both maternal and neonatal morbidity. Erythromycin, the only drug recommended for treatment during pregnancy, is often poorly tolerated, thus preventing successful cure. We have done a prospective, randomized, double-blind, placebo-controlled trial to compare the efficacy of clindamycin with that of erythromycin base in eradication of antenatal chlamydia. A total of 126 patients with documented cervical infection were enrolled before 24 weeks' gestation to receive clindamycin (450 mg), erythromycin (333 mg), or placebo orally four times daily for 14 days. Partners received doxycycline, 100 mg, twice daily for 7 days. Both clindamycin and erythromycin were effective agents with cure rates of 92.7% and 83.8%, respectively. Erythromycin therapy was associated with significantly more gastrointestinal complaints than was placebo therapy (23.1% (9/39) vs. 2.4% (1/41), p less than 0.02) whereas clindamycin was not. Patients who experienced side effects were more likely to be poorly compliant (p less than 0.03) and patients with moderate-to-good compliance were more likely to be cured than were women who were poorly compliant (p less than 0.002). Results of test of cure cultures performed immediately on completion of therapy did not differ significantly from those taken 4 weeks later. Azithromycin and erythromycin in the treatment of cervical chlamydial infection during pregnancy. OBJECTIVE: To compare azithromycin and erythromycin in regard to side effects, intolerance, and cure rate in a pregnant population with chlamydial cervicitis. METHODS: Thirty women were randomized to receive either erythromycin, 500 mg orally four times a day for 7 days, or azithromycin, 1 g orally as one dose. All subjects completed questionnaires identifying the incidence of nausea, vomiting, diarrhea, abdominal pain, and anorexia. Post-treatment cultures were taken from all subjects. RESULTS: All subjects receiving erythromycin reported two or more gastrointestinal side effects, versus none in the azithromycin group (P < .001). Five of 15 subjects in the erythromycin treatment arm were intolerant to the 500-mg dose given four times a day, compared to none in the azithromycin group (P < .025), so the dosage was lowered to 250 mg four times a day to complete the course. Repeat cervical testing demonstrated similar cure rates for both medications: 100 and 93% (14 of 15) for azithromycin and erythromycin, respectively. CONCLUSION: These data suggest that azithromycin is a valid treatment option in pregnant patients who cannot tolerate erythromycin because of side effects. Randomized Clinical Trial of Azithromycin vs. Erythromycin for the Treatment of Chlamydia Cervicitis in Pregnancy. OBJECTIVE: The purpose of this study was to prospectively test the null hypothesis that there is no difference in the clinical effectiveness of azithromycin and erythromycin for the treatment of chlamydia cervicitis in pregnancy. METHODS: All antepartum obstetrical patients underwent routine screening for chlamydia cervicitis using a DNA probe assay (Gen-Probe Pace, San Diego, CA). Women who tested positive for chlamydia cervicitis were prospectively randomized to receive either azithromycin 1 g orally at enrollment, or erythromycin 500 mg orally 4 times a day for 7 days. Sexual partners were referred to the county health department for evaluation and treatment. A test of cure was repeated in 2 weeks. RESULTS were analyzed by chi-square analysis and Fisher's exact test when indicated. RESULTS: One hundred forty women tested positive for chlamydia cervicitis and agreed to randomization. There were 4 (6.2%) treatment failures in the azithromycin group and 18 (27.7%) in the erythromycin group (P = 0.005). Gastrointestinal side effects were reported by 42 (65.5%) of the women taking erythromycin, but only 12 (19.4%) of those taking azithromycin (P < 0.002). Gastrointestinal side effects and resultant noncompliance were significantly related to treatment failure with erythromycin. CONCLUSIONS: The findings of this study support the conclusion that a single dose of azithromycin is a significantly more effective and better tolerated treatment regimen for chlamydia cervicitis in pregnancy than erythromycin which is currently recommended. Double-blind randomized study comparing amoxicillin and erythromycin for the treatment of Chlamydia trachomatis in pregnancy. OBJECTIVE: To compare the efficacy and patient tolerance of amoxicillin to that of erythromycin in the treatment of lower genital tract chlamydia infections during pregnancy. METHODS: A double-blind, randomized study was conducted comparing oral amoxicillin 500 mg three times daily versus oral erythromycin 500 mg four times daily for 7 days. One hundred forty-three women with positive cervical cultures for chlamydia at less than 36 weeks' gestation were enrolled. A test-of-cure culture was obtained 4 weeks after entry into the study and side effects were assessed. Success of the regimen was defined as completing the course of medication and having a negative test-of-cure culture. RESULTS: Thirty of the 65 women in the erythromycin group (46.1%) developed symptoms while taking the medication and 15 of them were unable to continue treatment (23.1%). In contrast, five of the 65 women (7.7%) in the amoxicillin group became symptomatic, with only one of these patients intolerant of the side effects (1.5%) (P < .001). Of the 50 patients in the erythromycin group who were able to complete their course of medication, only three had a positive test of cure (6.0%). In comparison, nine of the 64 patients (14.1%) taking amoxicillin who completed their course had positive cultures at test of cure. This difference was not statistically significant (P = .14). Forty-seven of the 65 patients (72.3%) in the erythromycin group successfully completed their regimen, compared to 55 of the 65 women (84.6%) in the amoxicillin group. This difference was not statistically significant. CONCLUSIONS: These findings suggest that amoxicillin is a reasonable alternative for the treatment of chlamydia in pregnant patients intolerant to erythromycin. The incidence of side effects and intolerance to therapy for amoxicillin are less than those for erythromycin. Double-Blind Placebo-Controlled Treatment Trial of Chlamydia trachomatis Endocervical Infections in Pregnant Women. OBJECTIVE: The purpose of this study was to determine if treatment of pregnant women with Chlamydia trachomatis infection would lower the incidence of preterm delivery and/or low birth weight. METHODS: Pregnant women between the 23rd and 29th weeks of gestation were randomized in double-blind fashion to receive either erythromycin 333 mg three times daily or an identical placebo. The trial continued until the end of the 35th week of gestation. RESULTS: When the results were examined without regard to study site, erythromycin had little impact on reducing low birth weight (8% vs. 11%, P = 0.4) or preterm delivery (13% vs. 15%, P = 0.7). At the sites with high persistence of C. trachomatis in the placebo-treated women, low birth weight infants occurred in 9 (8%) of 114 erythromycin-treated and 18 (17%) of 105 placebo-treated women (P = 0.04) and delivery <37 weeks occurred in 15 (13%) of 115 erythromycin-treated and 18 (17%) of 105 placebo-treated women (P = 0.4). CONCLUSIONS: The results of this trial suggest that the risk of low birth weight can be decreased by giving erythromycin to some women with C. trachomatis. Due to the high clearance rate of C. trachomatis in the placebo group, these data do not provide unequivocal evidence that erythromycin use in all C. trachomatis-infected women prevents low birth weight. Randomized trial of erythromycin and azithromycin for treatment of chlamydial infection in pregnancy. OBJECTIVE: The purpose of this study was to compare erythromycin and azithromycin in the treatment of chlamydial cervicitis during pregnancy with regard to efficacy, side effects, and compliance. METHODS: In a prospective manner, 48 pregnant patients with cervical chlamydial infections diagnosed by routine screening tests were randomly assigned to receive either erythromycin, 500 mg q.i.d. for 7 days (N = 24), or azithromycin, 1 g as a one-time dose (N = 24). All sexual partners were given prescriptions for doxycycline, 100 mg b.i.d. for 7 days. The treatment efficacy was assessed by follow-up chlamydia testing 3 weeks after the therapy was completed. The side effects, intolerance to therapy, and overall compliance were evaluated by means of a standardized posttreatment questionnaire. RESULTS: There was no significant difference in cure rates noted between the erythromycin group and the azithromycin group (77% vs. 91%, respectively; P = 0.24). Gastrointestinal side effects were reported more frequently among patients treated with erythromycin compared with patients treated with azithromycin (45% vs. 17%, respectively; P = 0.004). The patients who received erythromycin reported intolerance to therapy secondary to side effects more frequently than patients who received azithromycin (23% vs. 4%, respectively; P = 0.07). Furthermore, the patients in the azithromycin group were more likely to complete their course of therapy as prescribed than the patients in the erythromycin group (100% vs. 61%, respectively; P = 0.002). CONCLUSIONS: Azithromycin is efficacious and well tolerated for the treatment of chlamydial cervicitis in pregnancy. Erythromycin, though efficacious, is poorly tolerated, as demonstrated by the number of patients reporting significant side effects during the course of therapy. Since the cost of azithromycin is comparable to that of generic erythromycin, the present study supports the use of azithromycin as an alternative to erythromycin for the treatment of chlamydial cervicitis in pregnancy. Randomized trial of erythromycin and azithromycin for treatment of chlamydial infection in pregnancy. OBJECTIVE: The purpose of this study was to compare erythromycin and azithromycin in the treatment of chlamydial cervicitis during pregnancy with regard to efficacy, side effects, and compliance. METHODS: In a prospective manner, 48 pregnant patients with cervical chlamydial infections diagnosed by routine screening tests were randomly assigned to receive either erythromycin, 500 mg q.i.d. for 7 days (N = 24), or azithromycin, 1 g as a one-time dose (N = 24). All sexual partners were given prescriptions for doxycycline, 100 mg b.i.d. for 7 days. The treatment efficacy was assessed by follow-up chlamydia testing 3 weeks after the therapy was completed. The side effects, intolerance to therapy, and overall compliance were evaluated by means of a standardized posttreatment questionnaire. RESULTS: There was no significant difference in cure rates noted between the erythromycin group and the azithromycin group (77% vs. 91%, respectively; P = 0.24). Gastrointestinal side effects were reported more frequently among patients treated with erythromycin compared with patients treated with azithromycin (45% vs. 17%, respectively; P = 0.004). The patients who received erythromycin reported intolerance to therapy secondary to side effects more frequently than patients who received azithromycin (23% vs. 4%, respectively; P = 0.07). Furthermore, the patients in the azithromycin group were more likely to complete their course of therapy as prescribed than the patients in the erythromycin group (100% vs. 61%, respectively; P = 0.002). CONCLUSIONS: Azithromycin is efficacious and well tolerated for the treatment of chlamydial cervicitis in pregnancy. Erythromycin, though efficacious, is poorly tolerated, as demonstrated by the number of patients reporting significant side effects during the course of therapy. Since the cost of azithromycin is comparable to that of generic erythromycin, the present study supports the use of azithromycin as an alternative to erythromycin for the treatment of chlamydial cervicitis in pregnancy. A randomized, prospective trial comparing amoxicillin and erythromycin for the treatment of Chlamydia trachomatis in pregnancy. OBJECTIVE: Our purpose was to evaluate the efficacy of amoxicillin as an alternative therapy to erythromycin for the treatment of cervical chlamydial infections during pregnancy. STUDY DESIGN: A randomized, prospective trial of two treatment regimens for Chlamydia trachomatis was performed in a cohort of pregnant women enrolled for care in an inner-city, university-based prenatal clinic, with an alternate-therapy crossover arm for primary treatment failures. Pregnant women diagnosed with chlamydial infection by McCoy cell culture of cervical swabs were assigned to receive either 500 mg of amoxicillin three times daily or 500 mg of erythromycin four times daily for 7 days. Patients' partners were treated with doxycycline. Compliance information was obtained by a standardized questionnaire at a posttherapy follow-up visit. Patients with positive follow-up cultures were crossed over into the alternate treatment arm and recultured at a later visit. RESULTS: During the study period 74 women consented to participate in this trial; 36 were treated with amoxicillin and 38 with erythromycin. Initial cure rates of 82.3% (28/34) for the amoxicillin group and 84.6% (27/32) for erythromycin were obtained before crossover (p = 0.91); four patients in each group were lost to follow-up. Overall cure rates after crossover were 84.6% (33/39) for amoxicillin and 84.2% (32/38) for erythromycin (p = 0.83). In the amoxicillin group 12.8% of patients reported side effects compared with 31.6% treated with erythromycin (p = 0.09), although seven erythromycin-treated patients compared with none of those in the amoxicillin arm stopped therapy because of side effects (p = 0.02). CONCLUSION: Amoxicillin offers a reasonable alternative to erythromycin for the treatment of Chlamydia trachomatis in pregnancy, on the basis of both cure rates and patient compliance. A randomized, prospective trial comparing amoxicillin and erythromycin for the treatment of Chlamydia trachomatis in pregnancy. OBJECTIVE: Our purpose was to evaluate the efficacy of amoxicillin as an alternative therapy to erythromycin for the treatment of cervical chlamydial infections during pregnancy. STUDY DESIGN: A randomized, prospective trial of two treatment regimens for Chlamydia trachomatis was performed in a cohort of pregnant women enrolled for care in an inner-city, university-based prenatal clinic, with an alternate-therapy crossover arm for primary treatment failures. Pregnant women diagnosed with chlamydial infection by McCoy cell culture of cervical swabs were assigned to receive either 500 mg of amoxicillin three times daily or 500 mg of erythromycin four times daily for 7 days. Patients' partners were treated with doxycycline. Compliance information was obtained by a standardized questionnaire at a posttherapy follow-up visit. Patients with positive follow-up cultures were crossed over into the alternate treatment arm and recultured at a later visit. RESULTS: During the study period 74 women consented to participate in this trial; 36 were treated with amoxicillin and 38 with erythromycin. Initial cure rates of 82.3% (28/34) for the amoxicillin group and 84.6% (27/32) for erythromycin were obtained before crossover (p = 0.91); four patients in each group were lost to follow-up. Overall cure rates after crossover were 84.6% (33/39) for amoxicillin and 84.2% (32/38) for erythromycin (p = 0.83). In the amoxicillin group 12.8% of patients reported side effects compared with 31.6% treated with erythromycin (p = 0.09), although seven erythromycin-treated patients compared with none of those in the amoxicillin arm stopped therapy because of side effects (p = 0.02). CONCLUSION: Amoxicillin offers a reasonable alternative to erythromycin for the treatment of Chlamydia trachomatis in pregnancy, on the basis of both cure rates and patient compliance. Randomized prospective study comparing erythromycin, amoxicillin, and clindamycin for the treatment of chlamydia trachomatis in pregnancy. OBJECTIVE: The purpose of this study was to compare the efficacy and side effects of erythromycin, amoxicillin, and clindamycin in eradicating Chlamydia trachomatis from the lower genital tract of pregnant women. METHODS: A total of 174 women at <36 weeks gestation with positive cervical cultures for C. trachomatis were enrolled. Patients were assigned in a randomized prospective fashion to either erythromycin (500 mg q.i.d, for 7 days), amoxicillin (500 mg t.i.d, for 7 days), or clindamycin (600 mg t.i.d, for 10 days). Six women elected not to participate and 8 patients were lost to follow-up, leaving 53 patients in the erythromycin group, 55 patients in the amoxicillin group, and 52 patients in the clindamycin group. All sexual partners of the enrolled women were offered doxycycline (100 mg b.i.d. for 7 days) and patients were instructed to use barrier contraception until treatment was complete. RESULTS: All 3 medications were effective agents for the treatment of antenatal C. trachomatis infection with treatment efficacies of 96%, 94%, and 98% for the erythromycin, amoxicillin, and clindamycin groups, respectively. When the antibiotic groups were compared, no statistically significant differences were noted in intolerance. However, the differences in the incidence of gastrointestinal symptoms between erythromycin and amoxicillin and/or clindamycin were significant (P < 0.05). CONCLUSIONS: These findings suggest that 1) all 3 antibiotic regimens are efficacious, 2) erythromycin has a higher incidence of side effects, and 3) amoxicillin or clindamycin are reasonable alternatives for the treatment of C. trachomatis in pregnant patients unable to tolerate erythromycin. Options: A: Amoxycillin was found to be less effective than erythromycin but better tolerated. B: Amoxycillin was found to be as effective as erythromycin and better tolerated. C: Clindamycin and azithromycin were found to be ineffective. D: Erythromycin was found to be the only effective antibiotic.	B
5	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness of different antibiotic regimens for treating gonorrhoea in pregnant women in terms of microbiological cure? Please answer this question based on the information provided below: Treatment of gonorrhea in pregnancy. OBJECTIVE: To evaluate prospectively the 1989 Centers for Disease Control recommendations for treatment of gonorrhea in pregnancy. METHODS: Two hundred fifty-two women referred with probable endocervical gonorrhea had pre-treatment endocervical, rectal, and oral cultures for Neisseria gonorrhoeae and direct fluorescent antibody testing for Chlamydia trachomatis. They were assigned randomly to receive ceftriaxone 250 mg intramuscularly (IM), spectinomycin 2 g IM, or amoxicillin 3 g orally plus probenecid 1 g orally. Treatment was unblinded and in a 1:1:1 distribution. RESULTS: Two hundred forty-five women (97%) had endocervical infection, 68 (27%) had rectal infection, and 17 (7%) had pharyngeal infection. One hundred two of 252 women (40%) had concomitant endocervical C trachomatis. The overall efficacy was 235 of 252 subjects (93%) (95% confidence interval [CI] 90.1-96.4%). Ceftriaxone was effective in 80 of 84 cases (95%) (95% CI 90.6-99.9%), amoxicillin with probenecid was effective in 75 of 84 cases (89%) (95% CI 82.5-96%), and spectinomycin was effective in 80 of 84 cases (95%) (95% CI 90.6-99.9%). No significant difference was noted in overall efficacy or by site of infection. There was no increased incidence of congenital malformations in the offspring spring of any treatment group. CONCLUSIONS: Ceftriaxone and spectinomycin are safe and effective for the treatment of gonorrhea in pregnancy. Amoxicillin with probenecid has lower efficacy and is not recommended for treatment of gonococcal infection in pregnancy. Treatment of gonorrhea in pregnancy. OBJECTIVE: To evaluate prospectively the 1989 Centers for Disease Control recommendations for treatment of gonorrhea in pregnancy. METHODS: Two hundred fifty-two women referred with probable endocervical gonorrhea had pre-treatment endocervical, rectal, and oral cultures for Neisseria gonorrhoeae and direct fluorescent antibody testing for Chlamydia trachomatis. They were assigned randomly to receive ceftriaxone 250 mg intramuscularly (IM), spectinomycin 2 g IM, or amoxicillin 3 g orally plus probenecid 1 g orally. Treatment was unblinded and in a 1:1:1 distribution. RESULTS: Two hundred forty-five women (97%) had endocervical infection, 68 (27%) had rectal infection, and 17 (7%) had pharyngeal infection. One hundred two of 252 women (40%) had concomitant endocervical C trachomatis. The overall efficacy was 235 of 252 subjects (93%) (95% confidence interval [CI] 90.1-96.4%). Ceftriaxone was effective in 80 of 84 cases (95%) (95% CI 90.6-99.9%), amoxicillin with probenecid was effective in 75 of 84 cases (89%) (95% CI 82.5-96%), and spectinomycin was effective in 80 of 84 cases (95%) (95% CI 90.6-99.9%). No significant difference was noted in overall efficacy or by site of infection. There was no increased incidence of congenital malformations in the offspring spring of any treatment group. CONCLUSIONS: Ceftriaxone and spectinomycin are safe and effective for the treatment of gonorrhea in pregnancy. Amoxicillin with probenecid has lower efficacy and is not recommended for treatment of gonococcal infection in pregnancy. A randomized trial that compared oral cefixime and intramuscular ceftriaxone for the treatment of gonorrhea in pregnancy. OBJECTIVE: The purpose of this study was to evaluate prospectively the Centers for Disease Control recommendations for the treatment of gonococcal infection in pregnancy. STUDY DESIGN: One hundred sixty-one women who were referred with probable endocervical gonorrhea underwent pretreatment endocervical, anal, and oral cultures for Neisseria gonorrhoeae. The women were randomly assigned to receive ceftriaxone 125 mg intramuscularly or cefixime 400 mg orally. Treatment was open and in a 1:1 distribution. There were 95 evaluable patients. The tests of cure cultures were performed 4 to 10 days after treatment. RESULTS: Eighty-six women (91%) had endocervical infection; 39 women (41%) had anal infection, and 11 women (12%) had pharyngeal infection. Fifty of 95 women (53%) had concomitant endocervical chlamydial infection. The overall efficacy was 91 of 95 subjects (95.8%; 95% CI, 89.6%-98.8%). Ceftriaxone was effective in 41 of 43 cases (95%; 95% CI, 84.2%-99.4%), and cefixime was effective in 50 of 52 cases (96%; 95% CI, 86.8%-99.5%). No significant difference was noted in the overall efficacy or by site of infection. Three of the 4 women who experienced treatment failures admitted to unprotected intercourse before their test of cure culture. CONCLUSION: Both intramuscular ceftriaxone 125 mg and oral cefixime 400 mg appear to be effective for the treatment of gonococcal infection in pregnancy. Options: A: Amoxycillin with probenicid, spectinomycin, and ceftriaxone all have similar effects on microbiological cure. B: Only amoxycillin with probenicid was found to be effective in achieving microbiological cure. C: Spectinomycin and ceftriaxone were found to be less effective than amoxycillin with probenicid in achieving microbiological cure. D: None of the antibiotic regimens tested were effective in achieving microbiological cure.	A
6	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What interventions have been found to be effective in decreasing the risk of mother-to-child transmission of HIV infection? Please answer this question based on the information provided below: Zidovudine for the reduction of perinatal human immunodeficiency virus transmission: pediatric AIDS Clinical Trials Group Protocol 076--results and treatment recommendations. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. BACKGROUND AND METHODS: Maternal-infant transmission is the primary means by which young children become infected with human immunodeficiency virus type 1 (HIV). We conducted a randomized, double-blind, placebo-controlled trial of the efficacy and safety of zidovudine in reducing the risk of maternal-infant HIV transmission. HIV-infected pregnant women (14 to 34 weeks' gestation) with CD4+ T-lymphocyte counts above 200 cells per cubic millimeter who had not received antiretroviral therapy during the current pregnancy were enrolled. The zidovudine regimen included antepartum zidovudine (100 mg orally five times daily), intrapartum zidovudine (2 mg per kilogram of body weight given intravenously over one hour, then 1 mg per kilogram per hour until delivery), and zidovudine for the newborn (2 mg per kilogram orally every six hours for six weeks). Infants with at least one positive HIV culture of peripheral-blood mononuclear cells were classified as HIV-infected. RESULTS: From April 1991 through December 20, 1993, the cutoff date for the first interim analysis of efficacy, 477 pregnant women were enrolled; during the study period, 409 gave birth to 415 live-born infants. HIV-infection status was known for 363 births (180 in the zidovudine group and 183 in the placebo group). Thirteen infants in the zidovudine group and 40 in the placebo group were HIV-infected. The proportions infected at 18 months, as estimated by the Kaplan-Meier method, were 8.3 percent (95 percent confidence interval, 3.9 to 12.8 percent) in the zidovudine group and 25.5 percent (95 percent confidence interval, 18.4 to 32.5 percent) in the placebo group. This corresponds to a 67.5 percent (95 percent confidence interval, 40.7 to 82.1 percent) relative reduction in the risk of HIV transmission (Z = 4.03, P = 0.00006). Minimal short-term toxic effects were observed. The level of hemoglobin at birth in the infants in the zidovudine group was significantly lower than that in the infants in the placebo group. By 12 weeks of age, hemoglobin values in the two groups were similar. CONCLUSIONS: In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine given ante partum and intra partum to the mother and to the newborn for six weeks reduced the risk of maternal-infant HIV transmission by approximately two thirds. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. BACKGROUND AND METHODS: A placebo-controlled trial has shown that treatment with zidovudine reduces the rate at which human immunodeficiency virus type 1 (HIV-1) is transmitted from mother to infant. We present data from that trial showing the number of infected infants at 18 months of age and the relation between the maternal viral load, the risk of HIV-1 transmission, and the efficacy of zidovudine treatment. Viral cultures were obtained, and HIV-1 RNA was measured by two assays in samples of maternal blood obtained at study entry and at delivery. RESULTS: In 402 mother-infant pairs, the rate of transmission of HIV-1 was 7.6 percent (95 percent confidence interval, 4.3 to 12.3 percent) with zidovudine treatment and 22.6 percent (95 percent confidence interval, 17.0 to 29.0 percent) with placebo (P<0.001). In the placebo group, a large viral burden at entry or delivery or a positive culture was associated with an increased risk of transmission (the transmission rate was greater than 40 percent in the highest quartile of the RNA level). In both groups, transmission occurred at a wide range of maternal plasma HIV-1 RNA levels. Zidovudine reduced plasma RNA levels somewhat (median reduction, 0.24 log). Zidovudine was effective regardless of the HIV-1 RNA level or the CD4+ count at entry. In the zidovudine group, however, after we adjusted for the base-line HIV-1 RNA level and CD4+ count, the reduction in viral RNA from base line to delivery was not significantly associated with the risk of transmission of HIV-1. CONCLUSIONS: A high maternal plasma concentration of virus is a risk factor for the transmission of HIV-1 from an untreated mother to her infant. The reduction in such transmission after zidovudine treatment is only partly explained by the reduction in plasma levels of viral RNA. To prevent HIV-1 transmission, initiating maternal treatment with zidovudine is recommended regardless of the plasma level of HIV-1 RNA or the CD4+ count. 6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Côte d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial. DITRAME Study Group. DIminution de la Transmission Mère-Enfant. BACKGROUND: Zidovudine reduces the rate of vertical transmission of HIV in non-breastfed populations. We assessed the acceptability, tolerance, and 6-month efficacy of a short regimen of oral zidovudine in African populations practising breastfeeding. METHODS: A randomised double-blind placebo-controlled trial was carried out in public clinics of Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso. Eligible participants were women aged 18 years or older, who had confirmed HIV-1 infection and pregnancy of 36-38 weeks duration, and who gave written informed consent. Exclusion criteria were severe anaemia, neutropenia, abnormal liver function, and sickle-cell disease. Women were randomly assigned zidovudine (n=214; 300 mg twice daily until labour, 600 mg at beginning of labour, and 300 mg twice daily for 7 days post partum) or matching placebo (n=217). The primary outcome was the diagnosis of HIV-1 infection in the infant on the basis of sequential DNA PCR tests at days 1-8, 45, 90, and 180. We compared the probability of infection at a given age in the two groups. Analyses were by intention to treat. FINDINGS: Women were enrolled between September, 1995, and February, 1998, when enrolment to the placebo group was stopped. Analysis was based on 421 women and 400 lifeborn infants. Baseline demographic, clinical, and laboratory characteristics were similar in the two groups. The Kaplan-Meier probability of HIV infection in the infant at 6 months was 18.0% in the zidovudine group (n=192) and 27.5% in the placebo group (n=197; relative efficacy 0.38 [95% CI 0.05-0.60]; p=0.027). Adjustment for centre, period of recruitment, mode of delivery, maternal CD4-cell count, duration of labour, prolonged rupture of membranes, and duration of breastfeeding did not change the treatment effect. The proportions of women taking more than 80% of the planned maximum dose were 75% before delivery, 81% during labour, and 83% post partum, without statistical difference between the groups. No major adverse biological or clinical event was reported in excess among women and children of the zidovudine group. INTERPRETATION: A short course of oral zidovudine given during the peripartum period is well accepted and well tolerated, and provides a 38% reduction in early vertical transmission of HIV-1 infection despite breastfeeding. Prevention of mother-to-child transmission of HIV in Africa: uptake of pregnant women in a clinical trial in Abidjan, Côte d'Ivoire. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. BACKGROUND: The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life. METHODS: From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis. FINDINGS: Nearly all babies (98.8%) were breastfed, and 95.6% were still breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p=0.354); 21.3% and 11.9% by age 6-8 weeks (p=0.0027); and 25.1% and 13.1% by age 14-16 weeks (p=0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 20-64) up to age 14-16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups. INTERPRETATION: Nevirapine lowered the risk of HIV-1 transmission during the first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less-developed countries. A randomised trial of mode of delivery in women infected with the human immunodeficiency virus. OBJECTIVE: During the pilot phase of a trial to evaluate the effectiveness of caesarean section delivery compared with vaginal delivery in reducing mother-to-child transmission of human immunodeficiency virus (HIV) infection, the feasibility of randomisation to mode of delivery was assessed. DESIGN: At 36 weeks of pregnancy, women infected with HIV were randomly allocated to either caesarean section delivery at 38 weeks or vaginal delivery. Information was also collected on the reasons why women were not enrolled, either because they refused or had a contraindication. SETTING: Fifty-one centres in six European countries. POPULATION: Pregnant women with confirmed HIV-1 infection. MAIN OUTCOME MEASURES: Randomisation. RESULTS: Three-hundred and thirty-nine women had been randomised by the end of 1996, the large majority from Italy (n = 250) and France (n = 54), with 22 from South Africa, three from Sweden, nine from Barcelona and one from London. A further 150 women were eligible but had not been randomised. Forty-eight women (14%) were not delivered according to the arm to which they were randomised; the majority (n = 44) were changed from vaginal to caesarean section delivery. There is wide variation between European countries in the acceptability and adherence to the mode of delivery trial. CONCLUSION: The pilot phase of this trial has shown that in some settings randomisation to mode of delivery is feasible and acceptable, but that in other settings clinicians and pregnant women are more reluctant to be randomised. Pending further information on transmission rates and accrual, enrollment into the trial continues. Elective caesarean-section versus vaginal delivery in prevention of vertical HIV-1 transmission: a randomised clinical trial. BACKGROUND: Results from observational studies suggest that caesarean-section delivery may reduce the risk of mother-to-child transmission of HIV-1 infection in comparison with vaginal delivery. We carried out a randomised clinical trial to address this issue and to assess the extent of postdelivery complications. METHODS: Eligible women were between 34 and 36 weeks of pregnancy, with a confirmed diagnosis of HIV-1 infection, and without an indication for caesarean-section delivery or a contraindication to this mode of delivery. Women were randomly assigned elective caesarean-section delivery at 38 weeks of pregnancy or vaginal delivery. An infant was classified as uninfected if he or she became negative for antibody to HIV-1 by age 18 months or was negative for virus by PCR or culture on at least two occasions, with no clinical, immunological, or viral evidence of infection. From 1993, to March, 1998, 436 women were randomised. FINDINGS: We present the results of an analysis updated to November, 1998, with data on the infection status of 370 infants. Three (1.8%) of 170 infants born to women assigned caesarean-section delivery were infected, compared with 21 (10.5%) of 200 born to women assigned vaginal delivery (p<0.001). Seven (3.4%) of 203 infants of women who actually gave birth by caesarean section were infected compared with 15 (10.2%) of 167 born vaginally (p=0.009). There were few postpartum complications and no serious adverse events in either group. INTERPRETATION: Our findings provide evidence that elective caesarean-section delivery significantly lowers the risk of mother-to-child transmission of HIV-1 infection without a significantly increased risk of complications for the mother. Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group. BACKGROUND: Many developing countries have not implemented the AIDS Clinical Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission because of its complexity and cost. We investigated the safety and efficacy of short-course oral zidovudine administered during late pregnancy and labour. METHODS: In a randomised, double-blind, placebo-controlled trial, HIV-1-infected pregnant women at two Bangkok hospitals were randomly assigned placebo or one zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of labour until delivery. Mothers were given infant formula and asked not to breastfeed. The main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth, 2 months, and 6 months. We measured maternal plasma viral concentrations by RNA PCR. FINDINGS: Between May, 1996, and December, 1997, 397 women were randomised; 393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25 days, and median number of doses during labour was three. 99% of women took at least 90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of 392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and 37 in the placebo group. The estimated transmission risks were 9.4% (95% CI 5.2-13.5) on zidovudine and 18.9% (13.2-24.2) on placebo (p=0.006; efficacy 50.1% [15.4-70.6]). Between enrolment and delivery, women in the zidovudine group had a mean decrease in viral load of 0.56 log. About 80% of the treatment effect was explained by lowered maternal viral concentrations at delivery. INTERPRETATION: A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during late pregnancy and labour in less-developed countries unable to implement the full 076 regimen. Administration of zidovudine during late pregnancy and delivery to prevent perinatal HIV transmission--Thailand, 1996-1998. Worldwide, approximately 500,000 infants are perinatally infected with human immunodeficiency virus (HIV) each year, most of whom are born in developing countries. In 1994, a clinical trial in the United States and France demonstrated that zidovudine (ZDV) administered orally five times a day to HIV-infected pregnant women starting at 14-34 weeks' gestation, intravenously during labor, and orally to their newborns for 6 weeks reduced the risk for perinatal HIV transmission by two thirds. In 1994, this regimen was recommended as standard care in the United States; however, because of its complexity and cost, this regimen has not been implemented in most developing countries, and no other intervention had been efficacious in reducing perinatal HIV transmission. In 1996, the Ministry of Public Health of Thailand and Mahidol University, in collaboration with CDC, initiated a randomized, placebo-controlled trial of a simpler and less expensive regimen of ZDV to prevent perinatal HIV transmission. This report describes preliminary trial results, which indicate that a short-term antenatal regimen of ZDV reduced the risk for perinatal HIV transmission by approximately half. Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns. Pediatric AIDS Clinical Trials Group Protocol 185 Pharmacokinetic Study Group. The pharmacokinetics and safety of hyperimmune anti-human immunodeficiency virus (HIV) intravenous immunoglobulin (HIVIG) were evaluated in the first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV transmission prophylaxis. Using 200 mg/kg, mean half-life and volume of distribution (Vd) in women were 15 days and 72 mL/kg, respectively, after one and 32 days and 154 mL/kg after three monthly infusions, with stable 4 mL/kg/day clearance. Transplacental passage occurred. Newborn single-dose half-life, Vd, and clearance were 30 days, 143 mL/kg, and 4 mL/kg/day, respectively. HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen, and plasma HIV-1 RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 103 maternal and 2 of 25 infant infusions. No adverse hematologic, blood chemistry, or immunologic effects were seen. HIVIG is well-tolerated in HIV-infected pregnant women and their newborns, clears antigenemia, crosses the placenta, and exhibits pharmacokinetics similar to those of other immunoglobulin preparations. Efficacy of zidovudine and human immunodeficiency virus (HIV) hyperimmune immunoglobulin for reducing perinatal HIV transmission from HIV-infected women with advanced disease: results of Pediatric AIDS Clinical Trials Group protocol 185. Pediatric AIDS Clinical Trials Group protocol 185 evaluated whether zidovudine combined with human immunodeficiency virus (HIV) hyperimmune immunoglobulin (HIVIG) infusions administered monthly during pregnancy and to the neonate at birth would significantly lower perinatal HIV transmission compared with treatment with zidovudine and intravenous immunoglobulin (IVIG) without HIV antibody. Subjects had baseline CD4 cell counts </=500/microL (22% had counts <200/microL) and required zidovudine for maternal health (24% received zidovudine before pregnancy). Transmission was associated with lower maternal baseline CD4 cell count (odds ratio, 1.58 per 100-cell decrement; P=.005; 10.0% vs. 3.6% transmission for count <200 vs. >/=200/microL) but not with time of zidovudine initiation (5.6% vs. 4.8% if started before vs. during pregnancy; P=. 75). The Kaplan-Meier transmission rate for HIVIG recipients was 4. 1% (95% confidence interval, 1.5%-6.7%) and for IVIG recipients was 6.0% (2.8%-9.1%) (P=.36). The unexpectedly low transmission confirmed that zidovudine prophylaxis is highly effective, even for women with advanced HIV disease and prior zidovudine therapy, although it limited the study's ability to address whether passive immunization diminishes perinatal transmission. Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Côte d'Ivoire: a randomised trial. BACKGROUND: In Africa, the risk of mother-to-child transmission of HIV-1 infection is high. Short-course perinatal oral zidovudine might decrease the rate of transmission. We assessed the safety and efficacy of such a regimen among HIV-1-seropositive breastfeeding women in Abidjan, Côte d'Ivoire. METHODS: From April, 1996, to February, 1998, all consenting, eligible HIV-1-seropositive pregnant women attending a public antenatal clinic in Abidjan were enrolled at 36 weeks' gestation and randomly assigned placebo or zidovudine (300 mg tablets), one tablet twice daily until the onset of labour, one tablet at onset of labour, and one tablet every 3 h until delivery. We used HIV-1-DNA PCR to test the infection status of babies at birth, 4 weeks, and 3 months. We stopped the study on Feb 18, 1998, when efficacy results were available from a study in Bangkok, Thailand, in which the same regimen was used in a non-breastfeeding population. FINDINGS: 280 women were enrolled (140 in each group). The median duration of the prenatal drug regimen was 27 days (range 1-80) and the median duration of labour was 7.5 h. Treatment was well tolerated with no withdrawals because of adverse events. All babies were breastfed. Among babies with known infection status at age 3 months, 30 (26.1%) of 115 babies in the placebo group and 19 (16.5%) of 115 in the zidovudine group were identified as HIV-1 infected. The estimated risk of HIV-1 transmission in the placebo and zidovudine groups were 21.7% and 12.2% (p=0.05) at 4 weeks, and 24.9% and 15.7% (p=0.07) at 3 months. Efficacy was 44% (95% CI -1 to 69) at age 4 weeks and 37% (-5 to 63) at 3 months. INTERPRETATION: Short-course oral zidovudine was safe, well tolerated, and decreased mother-to-child transmission of HIV-1 at age 3 months. Substantial efforts will be needed to ensure successful widespread implementation of such a regimen. Options: A: Zidovudine, nevirapine, and elective caesarean section B: Zidovudine, hyperimmune immunoglobulin, and vaginal delivery C: Nevirapine, non-specific immunoglobulin, and vaginal delivery D: Elective caesarean section, non-specific immunoglobulin, and short course therapy	A
7	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness of calcium and sodium chloride in reducing leg cramps during pregnancy? Please answer this question based on the information provided below: The effect of oral magnesium substitution on pregnancy-induced leg cramps. OBJECTIVE: Our purpose was to determine whether women with pregnancy-related leg cramps would benefit from oral magnesium supplementation. STUDY DESIGN: Seventy-three women with pregnancy-related leg cramps were interviewed about their symptoms in a prospective, double-blind, randomized trial. Initial serum magnesium levels and diurnal magnesium excretion was determined in 50% of the patients. Oral magnesium or placebo was given for 3 weeks, after which new interviews and laboratory analyses were performed. RESULTS: Serum magnesium levels in these patients were at or below the lower reference limit, as is also often the case in healthy pregnant patients. Oral magnesium substitution decreased leg cramp distress (p < 0.05 compared with the placebo group, p < 0.001 compared with initial complaints), but did not significantly increase serum magnesium levels, excess magnesium being excreted as measured by an increase in urinary magnesium levels (p < 0.002). CONCLUSION: Oral magnesium supplementation seems to be a valuable therapeutic tool in the treatment of pregnancy-related leg cramps. Calcium treatment of leg cramps in pregnancy. Effect on clinical symptoms and total serum and ionized serum calcium concentrations. Up to 30 per cent of pregnant women suffer from leg cramps. The cause of these cramps is not known, but changes in calcium concentration have been suggested. Therefore 42 pregnant women with leg cramps were studied. No differences in total serum or ionized serum calcium concentrations were found as compared with a control group of pregnant women without leg cramps. Twenty-one patients were treated with 1 g calcium orally twice daily for 2 weeks and in this group good clinical improvement was achieved (p less than 0.001). The treatment increased the total serum calcium concentration from 2.25 mmol/l to 2.30 mmol/l but did not alter the ionized serum calcium concentration. Twenty-one untreated patients had the same frequency of cramps and showed no change in serum calcium concentrations throughout the investigation. Calcium and magnesium status in pregnant women. A comparison between treatment with calcium and vitamin C in pregnant women with leg cramps. 60 pregnant women underwent a double blind trial with calcium or ascorbic acid (1 g twice daily) as treatment for leg cramps. There was no significant difference between the two treatment groups with respect to clinical improvement. In 14 out of 60 patients the symptoms were totally abolished and in another 27 patients the symptoms were significantly decreased by the treatment (irrespective of drug used). In 17 patients the symptoms were unaffected while only two patients experienced an increase in frequency of their leg cramps during therapy. Serum total and ionized calcium concentrations, serum total magnesium and albumin concentrations were determined and were not significantly changed throughout therapy in any of the groups. No biochemical differences were found between the different treatment regimens or between those patients relieved or not relieved of their symptoms. Serum magnesium concentrations were at or just below the lower normal limit (for non pregnant women) in treated women and pregnant controls. Cramps in pregnancy. Effects of a multivitamin mineral supplement on zinc and copper status during pregnancy. The effect of a multivitamin-mineral supplement was investigated during pregnancy according to a double-blind protocol by determining zinc and copper in maternal plasma, mononuclear and polynuclear zinc and copper at the third, sixth, eighth, and ninth months of gestation. The subjects were supplemented from the first trimester until delivery. A significant decrease was observed in plasma zinc that varied from 11.5 mumol/L to 10.8 mumol/L in the supplemented group (n = 29) and from 11 mumol/L to 10 mumol/L in the placebo group (n = 33) at 3 and 9 mo of gestation, respectively. In contrast, plasma copper levels increased in a way depending upon the stage of gestation in both groups: from 24.7 to 28.2 mumol/L in the treated group and from 24.9 to 30.9 mumol/L in the placebo group at 3 and 9 mo of gestation, respectively, but the difference was only significant in the placebo group. No difference between groups was observed in mononuclear and polynuclear zinc or copper levels. These trace elements were also determined in cord blood at delivery. There were no statistically significant differences in zinc and copper concentration found in placebo group and supplemented group. Finally, the beneficial effect of supplementation on muscular cramps and appearance of vergetures was noted. Options: A: Calcium was found to be ineffective, while sodium chloride significantly reduced leg cramps. B: Both calcium and sodium chloride were found to reduce leg cramps, but the results for sodium chloride may be outdated due to dietary changes. C: Calcium significantly reduced leg cramps, but sodium chloride had no effect. D: Neither calcium nor sodium chloride had any significant effect on reducing leg cramps.	B
8	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What is the effect of maternal hydration on amniotic fluid volume in pregnant women with oligohydramnios or normal amniotic fluid volume? Please answer this question based on the information provided below: Effect of maternal hydration on oligohydramnios: a comparison of three volume expansion methods. OBJECTIVE: To determine the effect of maternal hydration with intravenous (i.v.) isotonic fluid, i.v. hypotonic fluid, and oral water on amniotic fluid index (AFI) in women with oligohydramnios. METHODS: Patients with low AFI and gestational age over 35 weeks without maternal complications were randomized into four groups (2 L/2 h i.v. isotonic fluid, 2 L/2 h i.v. hypotonic fluid, 2 L/2 h oral water, control). Maternal plasma osmolality, AFI, hematocrit, and hemoglobin concentration were measured before and after hydration. RESULTS: Eighty-four patients (n=21/group) completed the study without any maternal adverse effects. The mean increase in AFI after hydration was significantly greater in the i.v. hypotonic and oral water groups (2.8+/-1.9, P < .001; 3.8 +/-1.9, P < .001, respectively), but not in the i.v. isotonic group (0.5+/-1.1), compared with the control group (0.5+/-1.1). Significant decreases in maternal hematocrit and hemoglobin concentration were found only after i.v. isotonic hydration (32.0+/-2.9 to 29.5+/-2.3, P < .001; 11.0+/-1.6 to 10.1+/-1.4, P < .001, respectively). Changes in maternal osmolality correlated with the changes in AFI in both the i.v. hypotonic group (r=.58, P < .001) and oral water group (r =.63, P < .001). CONCLUSION: Maternal hydration with either i.v. hypotonic fluid or oral water increases AFI in oligohydramnios. Maternal osmotic change rather than maternal volume expansion had a more direct impact on increasing amniotic fluid volume with short-term acute hydration. Effect of maternal hydration on oligohydramnios: a comparison of three volume expansion methods. OBJECTIVE: To determine the effect of maternal hydration with intravenous (i.v.) isotonic fluid, i.v. hypotonic fluid, and oral water on amniotic fluid index (AFI) in women with oligohydramnios. METHODS: Patients with low AFI and gestational age over 35 weeks without maternal complications were randomized into four groups (2 L/2 h i.v. isotonic fluid, 2 L/2 h i.v. hypotonic fluid, 2 L/2 h oral water, control). Maternal plasma osmolality, AFI, hematocrit, and hemoglobin concentration were measured before and after hydration. RESULTS: Eighty-four patients (n=21/group) completed the study without any maternal adverse effects. The mean increase in AFI after hydration was significantly greater in the i.v. hypotonic and oral water groups (2.8+/-1.9, P < .001; 3.8 +/-1.9, P < .001, respectively), but not in the i.v. isotonic group (0.5+/-1.1), compared with the control group (0.5+/-1.1). Significant decreases in maternal hematocrit and hemoglobin concentration were found only after i.v. isotonic hydration (32.0+/-2.9 to 29.5+/-2.3, P < .001; 11.0+/-1.6 to 10.1+/-1.4, P < .001, respectively). Changes in maternal osmolality correlated with the changes in AFI in both the i.v. hypotonic group (r=.58, P < .001) and oral water group (r =.63, P < .001). CONCLUSION: Maternal hydration with either i.v. hypotonic fluid or oral water increases AFI in oligohydramnios. Maternal osmotic change rather than maternal volume expansion had a more direct impact on increasing amniotic fluid volume with short-term acute hydration. Maternal hydration increases amniotic fluid index. Although adequate amniotic fluid (AF) volume is considered an important aspect of fetal well-being, the etiology of decreased AF volume is not well understood. A randomized blinded trial was designed to examine our hypothesis that maternal hydration would increase the AF index in women with low AF indexes. Women seen in our testing centers were randomized into control or hydration groups. The control group was instructed to drink their normal amount of fluid; the hydration group was instructed to drink 2 L of water, in addition to their usual amount of fluid, 2-4 hours before the post-treatment AF index. The women returned for the post-treatment AF index the same or following day. The mean post-treatment AF index was significantly greater in the hydration group (6.3 versus 5.1; P less than .01), as was the mean change in AF index (post-treatment AF index--pre-treatment AF index: 1.5 versus 0.31; P less than .01). These findings suggest that maternal oral hydration increases AF volume in women with decreased fluid levels. Maternal hydration increases amniotic fluid index. Although adequate amniotic fluid (AF) volume is considered an important aspect of fetal well-being, the etiology of decreased AF volume is not well understood. A randomized blinded trial was designed to examine our hypothesis that maternal hydration would increase the AF index in women with low AF indexes. Women seen in our testing centers were randomized into control or hydration groups. The control group was instructed to drink their normal amount of fluid; the hydration group was instructed to drink 2 L of water, in addition to their usual amount of fluid, 2-4 hours before the post-treatment AF index. The women returned for the post-treatment AF index the same or following day. The mean post-treatment AF index was significantly greater in the hydration group (6.3 versus 5.1; P less than .01), as was the mean change in AF index (post-treatment AF index--pre-treatment AF index: 1.5 versus 0.31; P less than .01). These findings suggest that maternal oral hydration increases AF volume in women with decreased fluid levels. Maternal hydration increases amniotic fluid index in women with normal amniotic fluid. OBJECTIVE: To test the hypothesis that maternal oral hydration would increase the amniotic fluid (AF) index in pregnancies with normal AF. METHODS: Forty women with a normal AF index (7.0-24.0 cm) were randomized to either the control or hydration group. Women in the hydration group drank 2 L of water and returned for the post-treatment AF index in 4-6 hours, whereas women in the control group drank only 100 mL of water during the same time period. The investigator performing the AF index was blinded to the subject's group. The pre- and post-treatment AF indexes and maternal urine specific gravities were compared between the groups. RESULTS: The mean AF index in the hydration group increased significantly by 3.0 +/- 2.4 cm (P < or = .0001) whereas it declined significantly by 1.5 +/- 2.7 cm in the control group (P < or = .02). The maternal urine specific gravities also changed significantly in the expected direction, with those in the hydration group decreasing and those in the control group increasing (P < or = .0001). There was a regression coefficient of -0.6 (P < or = .0001) between the change in urine specific gravity and the change in AF index. The mean time between the pre- and post-treatment AF indexes was not different between the groups. CONCLUSIONS: Maternal oral hydration increased the AF index by approximately 16%, whereas fluid restriction decreased the AF index by 8% in women with normal AF. These findings support previous data that maternal hydration increased the AF index by 31% in women with decreased AF and suggest that maternal fluid volume or osmolality may have a role in maintaining the AF volume. A randomized clinical trial comparing the effect of maternal intravenous hydration and placebo on the amniotic fluid index in oligohydramnios. OBJECTIVE: To compare the treatment of acute intravenous hydration with placebo in term pregnant women manifesting oligohydramnios. METHODS: All patients with oligohydramnios who met the inclusion criteria were offered participation in this randomized, double-blind, placebo-controlled study. After ruling out rupture of membranes and maternal and fetal complications, we recruited 44 women with third trimester singleton pregnancies having an amniotic fluid index (AFI) of less than 6. Patients were randomized into treatment or control groups. Patients in the treatment group received a continuous intravenous infusion of (1/2) normal saline (NS) at a rate of 1000 mL/h for two hours. Patients in the placebo group received an intravenous infusion of (1/2) NS at 10 mL/h for two hours. The AFI was re-assessed by the same sonographer one hour after the hydration was completed. Both the patient and the examiner were blinded to the study groups. RESULTS: Maternal age, parity, gestational age, and birth weight were not significantly different between the two groups. The AFI increased significantly in both treatment (3.8 +/- 1.2 vs. 5.3 +/- 2.5, p < 0.05) and placebo (4 +/- 1.3 vs. 5.5 +/- 2.4, p < 0.05) groups. Moreover, the changes in AFI did not significantly differ between the treatment and the placebo groups (1.2 +/- 2.1 vs. 1.5 +/- 2.1, respectively; p > 0.05). CONCLUSIONS: There are statistically significant short-term increases in the AFI in patients with oligohydramnios whether the patients are treated with intravenous fluids or not. The short-term increase in AFI may reflect physiologic diurnal variations in the amniotic fluid. Options: A: Maternal hydration has no effect on amniotic fluid volume. B: Maternal hydration decreases amniotic fluid volume. C: Maternal hydration increases amniotic fluid volume. D: Maternal hydration only affects amniotic fluid volume in women with normal amniotic fluid volume.	C
9	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness of maternal oxygen therapy for suspected impaired fetal growth on fetal growth and perinatal outcome? Please answer this question based on the information provided below: Maternal hyperoxygenation in the treatment of intrauterine growth retardation. OBJECTIVE: In the current study the efficacy of maternal hyperoxygenation on growth-retarded fetuses was evaluated. STUDY DESIGN: Thirty-six pregnant women with intrauterine growth retardation were studied. The patients were divided in oxygen-treated (n = 17) and untreated (n = 19) groups. Doppler analysis of the fetal circulation was performed on the arrival to the hospital, after 12 hours, and thereafter on alternate days until delivery. Fetal blood was sampled by cordocentesis for immediate blood gas analysis at entrance to the study and the day of delivery. RESULTS: Significant improvement in Doppler flow patterns in treated patients were found when compared with untreated women. The Doppler variations were associated with complementary modifications in fetal blood gas. These differences resulted in a significant modification in perinatal mortality with an incidence of 29% and 68% (p less than 0.01) in treated and untreated groups, respectively. CONCLUSION: Our data suggest a benefit of maternal hyperoxygenation in the treatment of fetal growth retardation. A prospective randomised comparison of the effect of continuous O2 therapy and bedrest on fetuses with absent end-diastolic flow on umbilical artery Doppler waveform analysis. A double-blind randomised controlled trial of continuous oxygen therapy for compromised fetuses. OBJECTIVE: To investigate the effect of chronic oxygen therapy in fetuses with absent end diastolic flow in the umbilical artery assessed by doppler analysis at 24-30 weeks of gestation. DESIGN: A double-blind, randomised control trial was performed with patients blindly allocated to receive humidified oxygen or humidified air. SETTING: A tertiary referral hospital in South Africa. PARTICIPANTS: Thirty-two women who presented between 24 and 30 weeks of gestation with a confirmed finding of absent end diastolic flow in the umbilical artery. METHODS: After randomisation patients were allocated to receive a 40% mixture of humidified oxygen or humidified air from uniform coloured gas cylinders which were marked either 'a' or 'b' All women received betamethasone from 27 weeks of gestation on a weekly basis. Cardiotocographs were used from 28 weeks of gestation; after 28 weeks of gestation an amniocentesis was considered to confirm fetal maturity. Women were expected to breath the allocated gas continuously apart from meals and visits to the toilet. MAIN OUTCOME MEASURES: Survival of the fetus was the main outcome measure with secondary outcome measures documenting improvement in the fetal condition in utero. RESULTS: There were 16 women randomised to receive oxygen and 16 to receive air. There were nine survivors in the oxygen group (56.3%) and six in the air group (37.5%) (relative risk 1.5, 95% confidence interval 0.7-3.2). There was a nonsignificant increase in mean birthweight in the oxygen group (858.3 grammes vs 774.4 grammes) and a nonsignificant increase in mean duration of treatment in the oxygen group (12.8 days vs 10.4 days). CONCLUSION: This study did not demonstrate that chronic oxygen therapy provides any benefits to compromised fetuses between 24 and 30 weeks of gestation. Larger studies with sufficient power are necessary to assess whether oxygen therapy can reduce perinatal mortality by a clinically useful amount in this group of patients. A double-blind randomised controlled trial of continuous oxygen therapy for compromised fetuses. OBJECTIVE: To investigate the effect of chronic oxygen therapy in fetuses with absent end diastolic flow in the umbilical artery assessed by doppler analysis at 24-30 weeks of gestation. DESIGN: A double-blind, randomised control trial was performed with patients blindly allocated to receive humidified oxygen or humidified air. SETTING: A tertiary referral hospital in South Africa. PARTICIPANTS: Thirty-two women who presented between 24 and 30 weeks of gestation with a confirmed finding of absent end diastolic flow in the umbilical artery. METHODS: After randomisation patients were allocated to receive a 40% mixture of humidified oxygen or humidified air from uniform coloured gas cylinders which were marked either 'a' or 'b' All women received betamethasone from 27 weeks of gestation on a weekly basis. Cardiotocographs were used from 28 weeks of gestation; after 28 weeks of gestation an amniocentesis was considered to confirm fetal maturity. Women were expected to breath the allocated gas continuously apart from meals and visits to the toilet. MAIN OUTCOME MEASURES: Survival of the fetus was the main outcome measure with secondary outcome measures documenting improvement in the fetal condition in utero. RESULTS: There were 16 women randomised to receive oxygen and 16 to receive air. There were nine survivors in the oxygen group (56.3%) and six in the air group (37.5%) (relative risk 1.5, 95% confidence interval 0.7-3.2). There was a nonsignificant increase in mean birthweight in the oxygen group (858.3 grammes vs 774.4 grammes) and a nonsignificant increase in mean duration of treatment in the oxygen group (12.8 days vs 10.4 days). CONCLUSION: This study did not demonstrate that chronic oxygen therapy provides any benefits to compromised fetuses between 24 and 30 weeks of gestation. Larger studies with sufficient power are necessary to assess whether oxygen therapy can reduce perinatal mortality by a clinically useful amount in this group of patients. A double-blind randomised controlled trial of continuous oxygen therapy for compromised fetuses. OBJECTIVE: To investigate the effect of chronic oxygen therapy in fetuses with absent end diastolic flow in the umbilical artery assessed by doppler analysis at 24-30 weeks of gestation. DESIGN: A double-blind, randomised control trial was performed with patients blindly allocated to receive humidified oxygen or humidified air. SETTING: A tertiary referral hospital in South Africa. PARTICIPANTS: Thirty-two women who presented between 24 and 30 weeks of gestation with a confirmed finding of absent end diastolic flow in the umbilical artery. METHODS: After randomisation patients were allocated to receive a 40% mixture of humidified oxygen or humidified air from uniform coloured gas cylinders which were marked either 'a' or 'b' All women received betamethasone from 27 weeks of gestation on a weekly basis. Cardiotocographs were used from 28 weeks of gestation; after 28 weeks of gestation an amniocentesis was considered to confirm fetal maturity. Women were expected to breath the allocated gas continuously apart from meals and visits to the toilet. MAIN OUTCOME MEASURES: Survival of the fetus was the main outcome measure with secondary outcome measures documenting improvement in the fetal condition in utero. RESULTS: There were 16 women randomised to receive oxygen and 16 to receive air. There were nine survivors in the oxygen group (56.3%) and six in the air group (37.5%) (relative risk 1.5, 95% confidence interval 0.7-3.2). There was a nonsignificant increase in mean birthweight in the oxygen group (858.3 grammes vs 774.4 grammes) and a nonsignificant increase in mean duration of treatment in the oxygen group (12.8 days vs 10.4 days). CONCLUSION: This study did not demonstrate that chronic oxygen therapy provides any benefits to compromised fetuses between 24 and 30 weeks of gestation. Larger studies with sufficient power are necessary to assess whether oxygen therapy can reduce perinatal mortality by a clinically useful amount in this group of patients. Options: A: Maternal oxygen therapy significantly improved fetal growth and reduced perinatal mortality. B: Maternal oxygen therapy was associated with a lower perinatal mortality rate, but the evidence is insufficient to evaluate its overall benefits and risks. C: Maternal oxygen therapy had no effect on fetal growth or perinatal mortality. D: Maternal oxygen therapy increased the risk of adverse perinatal outcomes.	B
10	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What was the conclusion regarding the effectiveness of maternal nutrient supplementation for suspected impaired fetal growth on fetal growth and perinatal outcomes? Please answer this question based on the information provided below: [Maternal blood and amniotic fluid insulin-like growth factor detection and amniotic cavity drug delivery for early diagnosis and management of fetal growth restriction]. OBJECTIVE: To explore the relationship between insulin-like growth factors (IGFs) and fetal growth restriction (FGR) and early treatment of FGR. METHODS: The levels of IGF-I and IGF-II were detected with radioimmunoassay in maternal blood and amniotic fluid samples of 44 pregnant women with FGR and 36 normal gravidas. The 44 gravidas with FGR were randomized into treatment group with amino acid by a pediatric administration to the amniotic cavity formula and control group with intravenous infusion of compound amino acid. The therapeutic effects were compared between the two groups on the basis of B-type ultrasound findings. RESULTS: Maternal blood IGF-I and amniotic fluid IGF-I and IGF-II levels in the pregnant women with FGR were significantly lower than those in normal gravidas (P<0.01). After therapy, IGF-I and IGF-II levels were significantly increased in the treatment group (P<0.01), but no obvious changes in IGF-I and IGF-II levels were observed in the control group (P>0.05). Compared with the control group, IGF-I and IGF-II levels increased significantly in the amniotic fluid in the treatment group, with also marked elevation of IGF-I levels in maternal blood (P<0.01). Better therapeutic effects were achieved in the treatment group than in the control group (P<0.01), and the birth weights of the neonates in the treatment group were basically normal. CONCLUSIONS: Detection of amniotic fluid IGF-I and IGF-II and maternal blood IGF-I can help predict the condition and facilitate early diagnosis of FGR. Injection of pediatric amino acid into the amniotic cavity can be effective for treatment of FGR. [Carnitine in therapy of placental insufficiency--initial experiences]. Carnitine (3-hydroxy and 4-trimethylaminobutyrate) present in all living cells, plays an important role in the oxidation of fatty acids. It is known that high dose carnitine activates surfactant synthesis. Given to women with imminent premature delivery, its benefit on the post natal period is proved. Own studies showed an increased need of carnitine during pregnancy. Therefore the questions rose if carnitine substitution improves placental insufficiency. 15 pregnant women were treated with 2 x 1 g carnitine orally for one week and with 1 x 1 g carnitine during the following 7 days when their fetus showed a retardation of 1-3 weeks. The control group were 15 untreated patients with the same problems of retardation. The placental insufficiency was diagnosed by fetometry, by blood parameters and the doppler ultrasound flow measurement. In the group of the treated patients 11 out of 15 showed an improvement, in 4 patients no effect of carnitine was seen and in 1 patient the retardation increased. In the control group 8 out of 15 patients showed a spontaneous improvement of fetal growth, 2 women did not have a change in their retardation and 5 patients had to be hospitalized because of increasing placental insufficiency. Inspite of the small number of patients a tendency towards a profit in carnitine treatment for placental insufficiency seems to be real. [Effect of the protein-free calf-blood-extract (Solcoseryl) on the excretion of estrogens in chronic placental insufficiency]. In a double blind study the action of Solcoseryl was tested in 31 patients during late pregnancy with chronic placental insufficiency. Under treatment with Solcoseryl a significant increase in urinary estrogen excretion occurred in relation to the placebo-group. [Therapeutic efforts and prenatal modification of selected disordered fetomaternal relations]. Based on the current view about disturbances of the feto-materno-placental unit we examined 37 women with suspected intrauterine fetal growth retardation and 12 women with threatened premature labor and looked for possibilities of antenatal therapeutic influence of nutritive, respiratory, endocrine and hemodynamic insufficiency. In a randomized study we can prove a normal increase of the distance between symphysis pubis and fundus as well, as the biparietal diameter not only following bedrest but also following bedrest with additional intravenous infusion of glucose respectively oral application of galactose. The high rate of hypotrophic babies is no argument against a positive influence on nutritive insufficiency, but the acquired retardation can not be compensated totally. Neither a positive influence on the endocrine insufficiency nor the moderate respiratory one could be found. As well by maternal transcutaneous nerval stimulation as by maternal oxygen inhalation an oral long-term tocolysis we can demonstrate a considerable improvement of the uteroplacental perfusion measured with isotopes. These positive aspects are basis for further investigations. An important supposition to a successful therapy remains an early diagnosis. [Therapy of suspected intrauterine fetal retardation]. In a randomized prospective study, performed on 45 pregnancies with clinical and sonographic suspicion for intrauterine fetal growth retardation, examinations were done to evaluate the therapeutic effect of bed rest and of additional daily administered glucose infusions or oral galactose applications respectively on the fetal growth, the hemodynamic, respiratory and endocrine insufficiency of the materno-feto-placental unit as well as selected biochemical parameters of the umbilical blood. There is no positive therapeutic effect, either on the impaired endocrine partial function nor on the reduced respiratory function of the feto-placental unit. It is obvious, that despite the improvement of the nutritional supply of the fetus and the revival of the regular fetal growth, the previous lack of fetal growth can not be altered. This can be demonstrated in all three therapeutic groups due to the fact of a resulting high hypotrophy-rate of the newborns. The results prove that the additional supply of the fetus with glucose or galactose does not remarkably improve the therapeutic effectivity as opposed by strict bed rest alone. Options: A: Nutrient supplementation significantly improved fetal growth and reduced the number of small for gestational age infants. B: Nutrient supplementation had no significant effect on fetal growth or the number of small for gestational age infants. C: Nutrient supplementation significantly increased the number of small for gestational age infants. D: Nutrient supplementation had significant adverse effects on maternal health.	B
11	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What is the most effective treatment for symptomatic vaginal candidiasis in pregnancy, and what is the recommended duration of treatment? Please answer this question based on the information provided below: Comparative evaluation of Monistat and Mycostatin in the treatment of vulvovaginal candidiasis. Double-blind investigation of R-42470 (terconazole cream 0.4%) and clotrimazole (cream 1%) for the topical treatment of mycotic vaginitis. A total of 78 patients took part in a double-blind randomized comparison of the efficacy, acceptability and tolerance of a new antifungal terconazole (R-42470) (cream 0.4%) with the well established and clinically effective clotrimazole (cream 1%) for the topical treatment of mycotic vaginitis. Five grams of cream were applied to the vagina for 7 consecutive days. Twenty non-pregnant and 19 pregnant patients were included in each group. Clinical and mycological controls were carried out one week and one month after completion of therapy and 89.7% of the patients treated with terconazole responded to therapy and 82.1% patients treated with clotrimazole were cured. Statistical analysis showed no significant difference when the results of the terconazole treated patients and the clotrimazole group were compared. Candida albicans vaginitis: the problem is diagnosis, the enigma is treatment. At the UCLA Vulvovaginitis Clinic, 63 patients were diagnosed as having symptomatic Candida albicans vaginal infections. In a random select manner 3-day treatment with 200-mg clotrimazole suppositories was compared with 7-day treatment using 100-mg clotrimazole suppositories. 7- and 35-day follow-up of all patients entered revealed no statistical difference between the two groups, suggesting that short-term treatment is most efficacious and can be expected to work better since patient compliance is primarily a function of duration of treatment. In 50 cases of C. albicans patients treated with miconazole or clotrimazole in a random manner, the recurrence rate was 8 or 16. All patients in the study received perianal cultures for C. albicans before treatment and 7 and 35 days after treatment. 5 of the 8 patients with recurrence had perianal positive cultures at the 7- and 35-day check suggesting this as a source of recurrence. It is suggested that patients with persistently high perianal cultures after treatment be given an oral fungicide or fungistat to lower chronic recurrent C. albicans. Treatment of vulvovaginal candidiasis in pregnancy. A comparative study. A carefully controlled comparative study showed miconazole nitrate 2% vaginal cream (Monistat) to be a highly effective agent in the treatment of vaginal candidiasis in pregnant subjects. Miconazole nitrate was significantly more effective than nystatin (Mycostatin) in the treatment of vaginal candidiasis in all three trimesters of pregnancy, and also more effective regardless of whether the candidal infection was primary or recurrent. Observations relating to the safety of this therapy during pregnancy were made and discussed. Comparison of nystatin ('Nystan') and hydrargaphen ('Penotrane') in the treatment of vaginal candidosis in pregnancy. A dose-response study with Monistat cream. A randomized multiregimen clinical study was undertaken using Monistat Cream for the treatment of vulvovaginal candidiasis. The objective of the study was to find if there is a shorter regimen comparable in effectiveness to the currently marketed 14-day regimen. The results indicate that there is no significant difference between the cure rate obtained for 7 days of therapy and for 14 days of therapy. Monistat cream (miconazole nitrate) a new agent for the treatment of vulvovaginal candidiasis. Monistat Cream (miconazole nitrate 2%), a new fungicidal agent indicated for the treatment of vulvovaginal candidiasis, was evaluated in a comparative study with nystatin vaginal tablets (100,-000 units each). A total of 95 pregnant and non-pregnant patients were treated. Miconazole nitrate was administered once daily, at bedtime, for 14 days to 55 pregnant and non-pregnant patients. Overall, 74.5% (41 of 55 patients) were cured with one course of therapy. In contrast, of 40 nystatin-treated patients (both pregnant and non-pregnant) treated twice daily for 15 days, 22 patients (57.8%) were cured with one course of therapy. This difference in cure rates was statistically significant. Side effects were minimal and comparable in the two treatment groups. No recorded instances of birth defects were observed in infants born to mothers in either treatment group. Monistate Cream, in this study, was found to be a safe and effective drug in treating both pregnant and nonpregnant patients with confirmed candidiasis. Efficacy of econazole in the treatment of candidiasis and other vaginal discharges. Three hundred and thirty Black pregnant patients attending the Baragwanath Hospital antenatal clinic were treated for symptomatic vaginal discharge with econazole (Ecostatin; Squibb). Patients with positive Candida albicans cultures were treated for either 7 or 14 days. The results of treatment in both groups are presented. Prophylactic clotrimazole treatment to prevent mycoses contamination of the newborn. A comparative trial of six day therapy with clotrimazole and nystatin in pregnant patients with vaginal candidiasis. Options: A: Nystatin for 14 days B: Hydrargaphen for 7 days C: Imidazole for 7 days D: Clotrimazole for 3 days	C
12	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness of active chest physiotherapy for babies being extubated from mechanical ventilation for neonatal respiratory failure? Please answer this question based on the information provided below: Chest physiotherapy and post-extubation atelectasis in infants. We investigated the role of chest physiotherapy (CPT) in preventing post-extubation atelectasis (PEA) in infants. Sixty-three infants who were admitted to the neonatal intensive care unit and intubated for more than 24 hours and who showed no evidence of atelectasis by chest x-ray prior to extubation were enrolled in the study. Infants were randomly assigned to 2-hourly CPT, 4-hourly CPT, or a no CPT group. Chest physiotherapy began immediately after extubation and consisted of postural drainage, bilateral chest vibration, and suctioning. A second chest x-ray was obtained on all infants 24 hours following extubation. The three groups were comparable in birth weight, gestational age, and duration of intubation. In the 24-hour period following extubation, the incidence of PEA was not statistically significant in the three groups (P = 0.33). Two infants in the 2-hourly CPT group were placed on nasal continuous positive airway pressure; two in each of the 2-hourly and the no CPT groups required re-intubation and intermittent positive pressure ventilation to treat symptomatic atelectasis. We conclude that post extubation chest physiotherapy as used in this study did not prevent atelectasis in extubated infants. Routine neonatal postextubation chest physiotherapy: a randomized controlled trial. OBJECTIVE: To test the effects of a neonatal postextubation programme on the incidence of postextubation collapse and adverse outcomes. METHODS: A randomized controlled trial was carried out at the Mater Mothers' Hospital, Brisbane. Mechanically ventilated infants were randomized into one of two groups, physiotherapy group--which involved a regimen of chest wall percussion and oropharyngeal suctioning and control group - which involved suctioning without the percussion unless indicated. Chest X-rays were taken at 6 h and at 24 h postextubation. The primary outcome measure was postextubation collapse as determined by a paediatric radiologist blinded to the group allocation. RESULTS: One hundred and seventy-seven neonates were enrolled in the trial between 1997 and 1999. After an interim analysis, the trial was stopped early. No statistically significant difference was shown in the rate of postextubation collapse (15 of 87 (17.2%) physiotherapy group and 17 of 86 (19.8%) control group (P = 0.85)). No differences were shown between the groups in the number of apnoeic or bradycardic events, duration of requirement for supplemental oxygen or the need for re-intubation within 24 h postextubation. CONCLUSION: The results of this trial suggest that a routine neonatal postextubation chest physiotherapy programme for all infants is not indicated. There was no evidence that chest physiotherapy is associated with any adverse outcomes. Postextubation atelectasis: a retrospective review and a prospective controlled study. To determine the role of chest physiotherapy in the prevention of postextubation atelectasis in neonates intubated for greater than 24 hours, a retrospective survey compared the incidence of this complication in a newborn intensive care unit prior to and following the institution of a routine of chest physiotherapy. Eight of 23 infants extubated developed atelectasis in the "pre-physio" period, whereas only one collapse occurred in 20 infants treated with a routine of physiotherapy at extubation (P less than 0.025). Subsequently a prospective controlled trial compared the use of a routine of physiotherapy at extubation with no physiotherapy. Eight of 21 infants not receiving physiotherapy developed postextubation atelectasis and none of 21 infants receiving physiotherapy developed atelectasis (P less than 0.01). Seventy-six percent of the collapses involved the right upper lobe. A vigorous program of chest physiotherapy, including postural drainage emphasizing the positions of the right upper lobe and chest vibrations, will significantly reduce the incidence of postextubation atelectasis. Options: A: Active chest physiotherapy significantly reduced the rate of postextubation lobar collapse and reintubation. B: Active chest physiotherapy showed no clear benefit in reducing postextubation lobar collapse but reduced the use of reintubation. C: Active chest physiotherapy increased the rate of postextubation lobar collapse and had no effect on reintubation. D: Active chest physiotherapy had no effect on postextubation lobar collapse or reintubation.	B
13	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What are the effects of administering intravenous dexamethasone prior to extubation in newborn infants who have undergone intermittent positive pressure ventilation (IPPV)? Please answer this question based on the information provided below: Effects of dexamethasone on pulmonary function following extubation. Dexamethasone is often given to intubated neonates to facilitate successful extubation. To study the effects of dexamethasone on pulmonary function immediately following extubation, we conducted a randomized, blinded, placebo-controlled trial in 51 infants. All infants had been intubated for a minimum of 3 days but no more than 30 days. Mean weight at extubation was 2.41 kg in treated infants, 2.25 kg in control infants. When infants were deemed ready for extubation, dexamethasone 0.5 mg/kg/dose or an equal volume of normal saline was given in three doses 8 hours apart. The final dose was given 1 hour before extubation. Esophageal pressure, air flow integrated to tidal volume (Vt), respiratory rate, and heart rate were measured before extubation, immediately following extubation, and every 20 minutes for 80 minutes. Total pulmonary resistance (RTP), dynamic lung compliance (CL), and minute ventilation (VE) were calculated. Forty-two infants completed the study; 19 infants received dexamethasone and 23 received placebo. There was no difference between the two groups in gestational age, weight at study, or length of intubation. Vt, RTP, VE, and CL were not significantly different between the two groups over time; however, RTP increased over time in the placebo group. Heart rate was significantly lower in the dexamethasone group. We conclude that dexamethasone appears to have limited effect on pulmonary function immediately following extubation in the population studied. Further studies should evaluate the drug effect beginning at least 1 hour after extubation. Effectiveness of dexamethasone in preventing extubation failure in preterm infants at increased risk for airway edema. We studied 50 preterm infants who had multiple or traumatic endotracheal intubations, or whose duration of endotracheal intubation was > or = to 14 days, and who were considered at high risk for airway edema. These infants were enrolled in a prospective, randomized, controlled clinical trial to assess whether prophylactic dexamethasone therapy would be effective in the prevention of postextubation stridor and respiratory distress. At study entry, both groups had similar weights, postnatal ages, methylxanthine use, ventilator settings, blood gas values, and pulmonary function test results (dynamic compliance, total respiratory resistance, tidal volume, peak-to-peak transpulmonary pressure, minute ventilation, and peak inspiratory and expiratory flow rates). Patients underwent blood gas studies, physical examinations, and pulmonary function testing at baseline (4 hours before extubation) and again 2 to 4 hours and 18 to 24 hours after extubation. Twenty-seven infants received dexamethasone, 0.25 mg/kg per dose, at baseline, and then every 8 hours for a total of three doses; 23 infants received saline solution at corresponding times. Eighteen to twenty-four hours after extubation, total pulmonary resistance increased by 225% from baseline in the control group compared with 33% in the dexamethasone group (p < 0.006), and the dexamethasone group had a greater tidal volume, a greater dynamic compliance, and a lower arterial carbon dioxide pressure. Of 23 control infants, 10 had postextubation stridor compared with 2 of 27 dexamethasone-treated patients (p < 0.006). Of the 23 control patients, 4 required reintubation compared with none of the treated group (p < 0.05). We conclude that the prophylactic use of corticosteroids for the prevention of postextubation stridor and respiratory distress is efficacious in low birth weight, high-risk preterm infants. Routine use of dexamethasone for the prevention of postextubation respiratory distress. We evaluated the routine use of dexamethasone for the prevention of postextubation respiratory distress by entering 60 ventilated infants into a prospective, randomized, blinded study. Thirty minutes before extubation, 30 infants were given a single dose of intravenous dexamethasone (0.25 mg/kg), and 30 infants received saline placebo. Infants were intubated orotracheally for at least 48 hours following a single intubation and were maintained on low ventilator settings (F10(2) less than 0.35, intermittent mandatory ventilation [IMV] less than 6, positive end-expiratory pressure [PEEP] less than 4) at least 12 hours before extubation. Following extubation, all infants weighing less than 1500 g were routinely placed on nasal continuous positive airway pressure (NCPAP). There was no difference between the two groups in postextubation Downes' score, serum pH, PCO2, or oxygen requirement at 30 minutes, 6 hours, and 24 hours. Respiratory acidosis occurred in one steroid-treated patient and in two placebo-treated infants. Stridor occurred in four infants in each group. No infant developed postextubation lobar atelectasis or required reintubation. We conclude that prophylactic administration of dexamethasone does not improve the immediate postextubation course of infants following a single intubation and that its routine use at the time of extubation is not indicated. Options: A: It significantly reduces the need for reintubation and has no side effects. B: It significantly reduces the need for reintubation, but may cause higher blood sugar levels and glycosuria. C: It has no significant effect on the need for reintubation and causes no side effects. D: It increases the need for reintubation and causes higher blood sugar levels and glycosuria.	B
14	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What was the primary objective of the review comparing elective high frequency jet ventilation (HFJV) to conventional ventilation (CV) in preterm infants with respiratory distress syndrome (RDS)? Please answer this question based on the information provided below: Early randomized intervention with high-frequency jet ventilation in respiratory distress syndrome. To determine whether early use of high-frequency jet ventilation reduces neonatal mortality or pulmonary morbidity rates, we randomly selected 42 infants with clinical and radiographic evidence of severe respiratory distress syndrome to receive either high-frequency jet ventilation or conventional ventilation. Separate sequential analyses (two-sided, alpha = 0.05, power = 0.95 to detect 85:15 advantage) were performed for mortality rates, air leaks, bronchopulmonary dysplasia, intraventricular hemorrhage, and assignment crossover, and a combined analysis was performed, with death overriding other outcome variables. Enrollment was completed when the combined analysis reached the sequential design boundary indicating no treatment difference. Mortality rates (19% among infants receiving high-frequency jet ventilation vs 24% among infants receiving conventional ventilation), the incidence of air leaks (48% vs 52%), bronchopulmonary dysplasia (39% vs 41%), and intraventricular hemorrhage (33% vs 43%), and assignment crossovers (14% vs 24%) did not differs significantly between the treatment groups. We conclude that early use of high-frequency jet ventilation does not prevent or substantially reduce mortality or morbidity rates associated with assisted ventilation. Multicenter controlled clinical trial of high-frequency jet ventilation in preterm infants with uncomplicated respiratory distress syndrome. OBJECTIVE: To test the hypothesis that high-frequency jet ventilation (HFJV) will reduce the incidence and/or severity of bronchopulmonary dysplasia (BPD) and acute airleak in premature infants who, despite surfactant administration, require mechanical ventilation for respiratory distress syndrome. DESIGN: Multicenter, randomized, controlled clinical trial of HFJV and conventional ventilation (CV). Patients were to remain on assigned therapy for 14 days or until extubation, whichever came first. Crossover from CV to HFJV was allowed if bilateral pulmonary interstitial emphysema or bronchopleural fistula developed. Patients could cross over to the other ventilatory mode if failure criteria were met. The optimal lung volume strategy was mandated for HFJV by protocol to provide alveolar recruitment and optimize lung volume and ventilation/perfusion matching, while minimizing pressure amplitude and O2 requirements. CV management was not controlled by protocol. SETTING: Eight tertiary neonatal intensive care units. PATIENTS: Preterm infants with birth weights between 700 and 1500 g and gestational age <36 weeks who required mechanical ventilation with FIO2 >0.30 at 2 to 12 hours after surfactant administration, received surfactant by 8 hours of age, were <20 hours old, and had been ventilated for <12 hours. Outcome Measures. Primary outcome variables were BPD at 28 days and 36 weeks of postconceptional age. Secondary outcome variables were survival, gas exchange, airway pressures, airleak, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and other nonpulmonary complications. RESULTS: A total of 130 patients were included in the final analysis; 65 were randomized to HFJV and 65 to CV. The groups were of comparable birth weight, gestational age, severity of illness, postnatal age, and other demographics. The incidence of BPD at 36 weeks of postconceptional age was significantly lower in babies randomized to HFJV compared with CV (20.0% vs 40.4%). The need for home oxygen was also significantly lower in infants receiving HFJV compared with CV (5.5% vs 23.1%). Survival, incidence of BPD at 28 days, retinopathy of prematurity, airleak, pulmonary hemorrhage, grade I-II IVH, and other complications were similar. In retrospect, it was noted that the traditional HFJV strategy emphasizing low airway pressures (HF-LO) rather than the prescribed optimal volume strategy (HF-OPT) was used in 29/65 HFJV infants. This presented a unique opportunity to examine the effects of different HFJV strategies on gas exchange, airway pressures, and outcomes. HF-OPT was defined as increase in positive end-expiratory pressure (PEEP) by >/=1 cm H2O from pre-HFJV baseline and/or use of PEEP of >/=7 cm H2O. Severe neuroimaging abnormalities (PVL and/or grade III-IV IVH) were not different between the CV and HFJV infants. However, there was a significantly lower incidence of severe IVH/PVL in HFJV infants treated with HF-OPT compared with CV and HF-LO. Oxygenation was similar between CV and HFJV groups as a whole, but HF-OPT infants had better oxygenation compared with the other two groups. There were no differences in PaCO2 between CV and HFJV, but the PaCO2 was lower for HF-LO compared with the other two groups. The peak inspiratory pressure and DeltaP (peak inspiratory pressure-PEEP) were lower for HFJV infants compared with CV infants. CONCLUSIONS: HFJV reduces the incidence of BPD at 36 weeks and the need for home oxygen in premature infants with uncomplicated RDS, but does not reduce the risk of acute airleak. There is no increase in adverse outcomes compared with CV. HF-OPT improves oxygenation, decreases exposure to hypocarbia, and reduces the risk of grade III-IV IVH and/or PVL. High-frequency jet ventilation in the early management of respiratory distress syndrome is associated with a greater risk for adverse outcomes. OBJECTIVE: The objective of this investigation was to determine if high-frequency jet ventilation (HFJV) used early in the treatment of premature infants with respiratory distress syndrome was effective in reducing pulmonary morbidity without increasing the occurrence of adverse neurologic outcomes. STUDY DESIGN: A total of 73 premature infants who met the inclusion criteria (gestational age of less than 33 weeks, birth weight of more than 500 g, age of less than 24 hours, need for assisted ventilation with peak inspiratory pressure of more than 16 and FIO2 more than 0.30, and roentgenographic evidence of respiratory distress syndrome) were randomized to either conventional (n = 36) or to high-frequency jet (n = 37) ventilation. Our goals were to maintain the infants on the assigned ventilator for at least 7 days unless they could either be extubated or meet crossover criteria. Univariate analyses were initially used to compare the two groups. Stepwise logistic regression was subsequently used to assess whether various factors independently influenced adverse outcomes. RESULTS: The two groups of infants were similar in all obstetrical, perinatal, and neonatal demographic characteristics. The mean birth weight and gestational age in the conventional group were 930 g and 26.6 weeks and in the HFJV group, 961 g and 26.9 weeks. The infants were randomized at similar ages (7.1 and 7.3 hours of life, respectively). Their prerandomization ventilator settings and arterial blood gases were nearly identical. There were no differences in pulmonary outcomes (occurrence of air leaks, need for oxygen or ventilation at 36 weeks postconception), and there were no differences in the mean number of days oxygen was required, number of days ventilated, or length of hospital stay. Infants ventilated with HFJV were significantly more likely to develop cystic periventricular leukomalacia (10 vs 2, P = .022) or to have a poor outcome (grade IV hemorrhage, cystic periventricular leukomalacia, or death) (17 vs 7, P = .016). Logistic regression analysis revealed HFJV to be a significant independent predictor of both cystic periventricular leukomalacia and a poor outcome. The presence of hypocarbia was not an independently significant predictor of adverse outcomes. CONCLUSIONS: With the HFJV treatment strategy that we used, use of the high-frequency jet ventilator in the early management of premature infants with respiratory distress syndrome resulted in significantly more adverse outcomes than in those treated with conventional mechanical ventilation. Options: A: To determine if HFJV decreases the incidence of chronic lung disease (CLD) without adverse effects. B: To evaluate the cost-effectiveness of HFJV compared to CV. C: To assess the long-term neurodevelopmental outcomes of infants treated with HFJV. D: To compare the incidence of neonatal mortality between HFJV and CV.	A
15	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	In preterm infants at risk for apnea, what is the effect of prophylactic use of kinesthetic stimulation on the incidence of apnea, bradycardia, and the need for intermittent positive pressure ventilation (IPPV)? Please answer this question based on the information provided below: A controlled trial of a regularly cycled oscillating waterbed and a non-oscillating waterbed in the prevention of apnoea in the preterm infant. Fourteen preterm infants spent a mean of 23 hours divided into 4-hour periods with and without regular oscillations, 10 infants also being studied for control periods, before and afterwards. Electrocardiogram and impedance pneumogram were recorded continuously and analysed blindly. The waterbed, with or without oscillations, had no effect on apnoea or bradycardia when compared with control periods. Infants had appreciably more episodes of severe bradycardia while on the oscillating than on the non-oscillating waterbed. Effects of waterbed flotation on premature infants: A pilot study. Two types of waterbeds were developed to impart compensatory vestibular-proprioceptive stimulation to premature infants. Twenty-one infants ranging in gestational age from 27 to 34 weeks and birthweights from 1,050 to 1,920 gm were included in this pilot study. Assignment to experimental and control groups was made by random design. The experimental group consisted of ten infants who were placed on a gently oscillating waterbed before the sixth postnatal day, where they remained for seven days. Their clinical progress was compared with that of a control group of 11 similar babies. Waterbed flotation was found to be a safe procedure; there was no significant effects on the infants' vital signs, weight, or frequency of emesis. Highly significant differences were found in the incidence of apnea between the two groups, with infants on the oscillating waterbed having significantly fewer apneic spells. Infants placed on the waterbed during the first four postnatal days benefited more than those placed later. A non-oscillating waterbed was found clinically useful for very small prematures with severe skin problems, for infants recovering from abdominal surgery, and for infants receiving parenteral nutrition. Randomized clinical trial of an oscillating air mattress in preterm infants: effect on apnea, growth, and development. To investigate claims that oscillating mattresses reduce apnea of prematurity and improve growth and neurobehavioural development, we performed a randomized clinical trial using a predetermined sample size. Preterm infants weighing from 750 to 1750 gm at birth were randomly assigned, by 250 gm strata, to either a conventional mattress (n = 63) or to an air mattress (n = 59) oscillating at 14 to 16 regular pulses per minute. Infants remained on the oscillating air mattress for at least 7 days or until 34 weeks postmenstrual age. Apneic episodes occurred and required treatment equally in the two groups; this lack of an effect was seen for both sexes and all weight groups. Both weight and energy intake were similar. Neurobehavioral development as shown by sleep state, habituation testing, and behavioral assessment at term, 3, 6, and 12 months was similar in the two groups. There was no difference in the incidence of neurologic abnormalities. We conclude that an oscillating air mattress has no prophylactic value in reducing apnea and does not enhance growth and development. Randomized clinical trial of an oscillating air mattress in preterm infants: effect on apnea, growth, and development. To investigate claims that oscillating mattresses reduce apnea of prematurity and improve growth and neurobehavioural development, we performed a randomized clinical trial using a predetermined sample size. Preterm infants weighing from 750 to 1750 gm at birth were randomly assigned, by 250 gm strata, to either a conventional mattress (n = 63) or to an air mattress (n = 59) oscillating at 14 to 16 regular pulses per minute. Infants remained on the oscillating air mattress for at least 7 days or until 34 weeks postmenstrual age. Apneic episodes occurred and required treatment equally in the two groups; this lack of an effect was seen for both sexes and all weight groups. Both weight and energy intake were similar. Neurobehavioral development as shown by sleep state, habituation testing, and behavioral assessment at term, 3, 6, and 12 months was similar in the two groups. There was no difference in the incidence of neurologic abnormalities. We conclude that an oscillating air mattress has no prophylactic value in reducing apnea and does not enhance growth and development. Options: A: Prophylactic use of kinesthetic stimulation significantly reduces the incidence of apnea and bradycardia, and decreases the need for IPPV. B: Prophylactic use of kinesthetic stimulation has no significant effect on the incidence of apnea, bradycardia, or the need for IPPV. C: Prophylactic use of kinesthetic stimulation increases the incidence of apnea and bradycardia, and increases the need for IPPV. D: Prophylactic use of kinesthetic stimulation significantly improves long-term growth and development outcomes.	B
16	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the use of enteral antibiotic prophylaxis for preventing necrotising enterocolitis in low birth weight and preterm infants? Please answer this question based on the information provided below: Alterations in stool flora resulting from oral kanamycin prophylaxis of necrotizing enterocolitis. A prospective controlled trial of oral kanamycin in the prevention of neonatal necrotizing enterocolitis. Oral gentamicin therapy in the prevention of neonatal necrotizing enterocolitis. A controlled double-blind trial. The value of prophylactic oral gentamicin sulfate therapy in the prevention of necrotizing enterocolitis (NEC) was evaluated in a group of 42 high-risk neonates over a four-month period in a randomized, double-blind controlled trial. Twenty babies in the treatment group received 2.5 mg/kg of gentamicin sulfate every six hours for one week after birth, and 22 babies received dextrose-and-water placebo in an equivalently small volume. None of the 20 gentamicin-treated babies developed NEC. Four of the control babies did. Two of these babies died, and their diagnosis was pathologically confirmed. This difference in the incidence of NEC between the treatment and control group was significant at the .05 level. These results support the prophylactic use of orally given gentamicin for selected babies at high risk for NEC, particularly those born prematurely and those who have a history of perinatal asphyxia or umbilical artery catheterization or both. Continued surveillance for changes in antimicrobial sensitivity patterns is recommended. Gentamicin in prophylaxis of neonatal necrotising enterocolitis. Double blind, randomised, placebo controlled study of oral vancomycin in prevention of necrotising enterocolitis in preterm, very low birthweight infants. AIMS: To evaluate the effectiveness of oral vancomycin in the prophylaxis of necrotising enterocolitis in preterm, very low birthweight infants. METHODS: A prospective, double blind, randomised, placebo controlled study in a tertiary referral centre of a university teaching hospital was conducted on 140 very low birthweight infants consecutively admitted to the neonatal unit. The babies were randomly allocated to receive oral vancomycin (15 mg/kg every 8 hours for 7 days) or an equivalent volume of placebo solution. Prophylaxis was started 24 hours before the start of oral feeds. All suspected cases of necrotising enterocolitis were investigated with a full sepsis screen and serial abdominal radiographs. Necrotising enterocolitis was diagnosed and staged according to modified Bell's criteria. RESULTS: Nine of 71 infants receiving oral vancomycin and 19 of 69 infants receiving the placebo solution developed necrotising enterocolitis (p = 0.035). Infants with necrotising enterocolitis were associated with a significant increase in mortality (p = 0.026) and longer duration of hospital stay (p = 0.002). CONCLUSIONS: Prophylactic oral vancomycin conferred protection against necrotising enterocolitis in preterm, very low birthweight infants and was associated with a 50% reduction in the incidence. However, widespread implementation of this preventive measure is not recommended, as it would only be effective in necrotising enterocolitis caused by Gram positive organisms and could increase the danger of the emergence of vancomycin resistant or dependent organisms. Its use should be restricted to a high prevalence nursery for a short and well defined period in a selected group of high risk patients. Options: A: It significantly reduced the incidence of necrotising enterocolitis and NEC-related deaths without any increase in adverse outcomes. B: It significantly reduced the incidence of necrotising enterocolitis but had a borderline significant effect on reducing NEC-related deaths and increased the incidence of colonisation with resistant bacteria. C: It had no significant effect on the incidence of necrotising enterocolitis or NEC-related deaths and did not increase the incidence of colonisation with resistant bacteria. D: It significantly increased the incidence of necrotising enterocolitis and NEC-related deaths and also increased the incidence of colonisation with resistant bacteria.	B
17	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness of therapeutic ultrasound for treating acute perineal pain, persistent perineal pain, and dyspareunia following childbirth? Please answer this question based on the information provided below: Ultrasound and pulsed electromagnetic energy treatment for perineal trauma. A randomized placebo-controlled trial. Ultrasound and pulsed electromagnetic energy therapies are increasingly used for perineal trauma sustained during childbirth. The study included 414 women with moderate or severe perineal trauma randomly allocated to receive active ultrasound, or active pulsed electromagnetic energy, or corresponding placebo therapies; the allocation was double-blind for each machine. Overall, more than 90% thought that treatment made their problem better. There were no clear differences between the groups in outcome either immediately after treatment, or 10 days or 3 months postpartum, other than more pain associated with pulsed electromagnetic energy treatment at 10 days. Bruising looked more extensive after ultrasound therapy but then seemed to resolve more quickly. Neither therapy had an effect on perineal oedema or haemorrhoids. The place of these new therapies in postnatal care should be clarified by further controlled trials before they become part of routine care. Options: A: Therapeutic ultrasound significantly reduced acute perineal pain and dyspareunia, but had no effect on persistent perineal pain. B: Therapeutic ultrasound showed significant improvement in acute perineal pain and dyspareunia, but the evidence was insufficient to evaluate its overall effectiveness. C: Therapeutic ultrasound was effective in reducing both acute and persistent perineal pain, as well as dyspareunia. D: Therapeutic ultrasound had no significant effect on acute perineal pain, persistent perineal pain, or dyspareunia.	B
18	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	In preterm infants with apnea, what is the effect of kinesthetic stimulation on the reduction of clinical apnea and bradycardia, the use of mechanical ventilation or continuous positive airways pressure, and neurodevelopmental disability? Please answer this question based on the information provided below: The effect of vertical pulsating stimulation on apnea of prematurity. Placing preterm infants suffering idiopathic apnea of prematurity on the VPS had an effect on the infants' respiratory effort and achieved a reduction in the number of apneic episodes secondary to central and mixed apnea. However, VPS offered no benefits in the reduction of obstructive apnea in this study population. Because central apnea has been reported as the predominant type of apnea and VPS is a nontoxic, noninvasive, and easy-to-implement method of alleviating central and mixed apnea types, it seems prudent to give VPS which has the stimulus characteristics to preterm infants experiencing apnea of prematurity before other treatment modalities currently in use are tried. Further studies are warranted to determine if VPS is effective in a continuous long-term treatment for apnea of prematurity, for example, until the end of apnea. Reduction of sleep apnea and bradycardia in preterm infants on oscillating water beds: a controlled polygraphic study. The sleep and respiratory patterns of eight apneic preterm infants were polygraphically recorded for 24 hours. This polygraphic study was designed to test and extend our previous finding that gently oscillating water beds reduce apnea in premature infants. The infants who ranged in gestational age from 27 to 32 weeks and in birth weight from 1,077 to 1,650 gm served as their own controls, off and on the water bed. The 24-hour recordings were divided into four time blocks with the infant being placed on the water bed during alternate six-hour periods. Apnea was significantly reduced while the infants were on the oscillating water beds, with the longest apneic periods and those associated with severe bradycardia being reduced the most. Reduction of apnea was most consistent during indeterminate sleep and most pronounced during quiet sleep. Short respiratory pauses and periodic breathing were not significantly reduced. Reductions of central, obstructive, and mixed apneas were approximately equal. Effect of a rocking bed on apnoea of prematurity. We describe a rocking bed for use in incubators. Its effect was studied in 12 preterm infants with idiopathic apnoea, using each as his own control. All but one had less apnoea when the bed was rocking than when it was still. Apnoea associated with a significant fall in transcutaneous PO2 was less frequent, and fewer interventions were needed to terminate apnoeic attacks. Options: A: Kinesthetic stimulation leads to a significant reduction in clinical apnea and bradycardia, reduces the need for mechanical ventilation or CPAP, and decreases neurodevelopmental disability. B: Kinesthetic stimulation does not lead to a significant reduction in clinical apnea and bradycardia, does not reduce the need for mechanical ventilation or CPAP, and has no reported effect on neurodevelopmental disability. C: Kinesthetic stimulation increases the incidence of clinical apnea and bradycardia, increases the need for mechanical ventilation or CPAP, and worsens neurodevelopmental outcomes. D: Kinesthetic stimulation has mixed results, with some studies showing a reduction in clinical apnea and bradycardia, but no overall reduction in the need for mechanical ventilation or CPAP, and no data on neurodevelopmental outcomes.	B
19	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What is the conclusion regarding the effectiveness of routine endotracheal intubation at birth in vigorous term meconium-stained infants compared to routine resuscitation including oro-pharyngeal suction? Please answer this question based on the information provided below: Tracheal suction in meconium stained infants: a randomized controlled study. We performed a randomized controlled study of the mortality and morbidity of 49 babies born with thick meconium staining of amniotic fluid. These unasphyxiated babies were consecutively born and were admitted to the intensive care unit for observation as routine. The groups were comparable in regard to sex, birth weight, gestational age, maternal factors like anaemia, toxaemia, antepartum haemorrhage, prolonged rupture of membranes, presentation, and interventions including caesarian section. The control group, comprising 26 babies received only oropharyngeal suction, while the intervention group, comprising 23 babies, underwent oropharyngeal suction followed by tracheal suction. There was no significant difference in the mortality or morbidity in form of evidence of air leak or hypoxic ischaemic encephalopathy. Need for endotracheal intubation and suction in meconium-stained neonates. In a prospective study, we determined whether routine immediate tracheal aspiration at birth is necessary in meconium-stained but otherwise normal infants delivered vaginally and having a 1-minute Apgar score greater than 8. A total of 572 newborn infants who met these criteria were randomly allocated to one of two groups. All infants underwent oropharyngeal suctioning with a DeLee catheter while the head was still on the perineum. In group I (n = 308) suctioning of the trachea under direct vision was performed instantly at birth; in group II (n = 264) this procedure was not done. There was no mortality among infants in the study, but morbidity, mainly pulmonary and laryngeal disorders, occurred in six of 308 group I infants and in none of the group II infants (P less than 0.025). Immediate tracheal suction is not a harmless intervention, and should be considered superfluous in a vigorous term neonate born with meconium-stained amniotic fluid. The need for delivery room intubation of thin meconium in the low-risk newborn: a clinical trial. The delivery room management of meconium-stained amniotic fluid remains controversial. We attempted to determine if intubation of the low-risk newborn with thin meconium affects the incidence of respiratory symptoms. Exclusion criterion included moderate or thick meconium, fetal distress, neonatal depression, or prematurity. Eligible infants were randomized to either an intubation (group I) or to a nonintubation group (group II). The outcome was the presence of respiratory symptoms. Patients were studied from May 1994 to June 1997. There were 8967 births during this period: 7.9% (708/8967) were delivered through meconium. Thin meconium was noted in 50.3% (356/708) of all births. 24/356 infants with thin meconium were excluded for medical criterion. One hundred sixty-three infants were medically eligible but could not be randomized due to lack of consent, late arrival of the team, or obstetrician request. These were placed into intubation (group I B) and nonintubation (group II B) groups. Seventy-seven infants were randomized into group I and 92 infants into group II. From the intubation groups I and I B, one required supplemental oxygen and was weaned to room air in 7 hr. From the nonintubation groups II and II B, two infants required oxygen, weaning to room air in 11 and 46 hr. Comparing birth weight, gestational age, sex, mode of delivery and 5-min Apgar, there were no significant differences. However, the intubation groups had significantly lower 1-min Apgar scores. There was no airway morbidity reported in the intubation groups. In the infant with thin meconium and an otherwise low-risk pregnancy, we were unable to demonstrate a difference in respiratory symptoms with intubation and intratracheal suctioning. The need for delivery room intubation of thin meconium in the low-risk newborn: a clinical trial. The delivery room management of meconium-stained amniotic fluid remains controversial. We attempted to determine if intubation of the low-risk newborn with thin meconium affects the incidence of respiratory symptoms. Exclusion criterion included moderate or thick meconium, fetal distress, neonatal depression, or prematurity. Eligible infants were randomized to either an intubation (group I) or to a nonintubation group (group II). The outcome was the presence of respiratory symptoms. Patients were studied from May 1994 to June 1997. There were 8967 births during this period: 7.9% (708/8967) were delivered through meconium. Thin meconium was noted in 50.3% (356/708) of all births. 24/356 infants with thin meconium were excluded for medical criterion. One hundred sixty-three infants were medically eligible but could not be randomized due to lack of consent, late arrival of the team, or obstetrician request. These were placed into intubation (group I B) and nonintubation (group II B) groups. Seventy-seven infants were randomized into group I and 92 infants into group II. From the intubation groups I and I B, one required supplemental oxygen and was weaned to room air in 7 hr. From the nonintubation groups II and II B, two infants required oxygen, weaning to room air in 11 and 46 hr. Comparing birth weight, gestational age, sex, mode of delivery and 5-min Apgar, there were no significant differences. However, the intubation groups had significantly lower 1-min Apgar scores. There was no airway morbidity reported in the intubation groups. In the infant with thin meconium and an otherwise low-risk pregnancy, we were unable to demonstrate a difference in respiratory symptoms with intubation and intratracheal suctioning. Delivery room management of the apparently vigorous meconium-stained neonate: results of the multicenter, international collaborative trial. OBJECTIVE: Disagreement exists concerning the appropriate delivery room management of the airway of vigorous meconium-stained infants. Some suggest a universal approach to intubation and suctioning of the airway in all such neonates, whereas others advocate a selective approach. We performed this investigation: 1) to assess whether intubation and suctioning of apparently vigorous, meconium-stained neonates would reduce the incidence of meconium aspiration syndrome (MAS); and 2) to determine the frequency of complications from delivery room intubation and suctioning of such infants. METHODS: Inclusion criteria included: 1) gestational age >/=37 weeks; 2) birth through meconium-stained amniotic fluid of any consistency; and 3) apparent vigor immediately after birth. Subjects were randomized to be intubated and suctioned (INT) or to expectant management (EXP). Primary outcome measures included: 1) the incidence of respiratory distress, including MAS, and 2) the incidence of complications from intubation. RESULTS: A total of 2094 neonates were enrolled from 12 participating centers (1051 INT and 1043 EXP). Meconium-stained amniotic fluid consistency was similar in both groups. Of the 149 (7.1%) infants that subsequently demonstrated respiratory distress, 62 (3.0%) had MAS and 87 (4.2%) had findings attributed to other disorders. There were no significant differences between groups in the occurrence of MAS (INT = 3.2%; EXP = 2.7%) or in the development of other respiratory disorders (INT = 3.8%; EXP = 4.5%). Of 1098 successfully intubated infants, 42 (3.8%) had a total of 51 complications of the procedure. In all cases, the complications were mild and transient in nature. CONCLUSIONS: Compared with expectant management, intubation and suctioning of the apparently vigorous meconium-stained infant does not result in a decreased incidence of MAS or other respiratory disorders. Complications of intubation are infrequent and short-lived. Options: A: Routine endotracheal intubation significantly reduces mortality and respiratory complications. B: Routine endotracheal intubation is more beneficial than routine resuscitation including oro-pharyngeal suction. C: Routine endotracheal intubation has not been shown to be superior to routine resuscitation including oro-pharyngeal suction. D: Routine endotracheal intubation is recommended for all vigorous term meconium-stained infants.	C
20	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What was the conclusion regarding the effectiveness of teaching pregnant women specific criteria for self-diagnosis of active labour onset in term pregnancy? Please answer this question based on the information provided below: Recognizing the onset of labor. An experimental study compared the use of an educational technique based on patient participation with routine instructions to prepare patients to recognize the onset of active labor. The number of visits to the labor suite that resulted in the patient being discharged undelivered was significantly lower in patients who received the educational intervention. The study revealed that, without any increase in time, nurses can prepare patients to make judgments about the need for hospitalization. Options: A: The program significantly reduced the number of early admissions to the hospital. B: The program increased women's confidence and decreased their anxiety. C: There is insufficient evidence to evaluate the effectiveness of the program. D: The program resulted in fewer women being sent home because they were not in labour.	C
21	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the effects of caregivers using specific criteria to diagnose active labour in term pregnancy compared to routine care? Please answer this question based on the information provided below: An early labor assessment program: a randomized, controlled trial. BACKGROUND: Approximately 31 percent of cesarean deliveries in the United States and Canada are performed for dystocia. The aim of this study was to determine the effectiveness of early labor assessment to reduce cesarean birth rates for low-risk nulliparous women. METHODS: Two hundred and nine low-risk nulliparous women were randomly allocated to either the early labor assessment group or the direct admission to hospital group. Women in the early labor assessment group were evaluated and, if found to be in false or latent labor, were encouraged to go home or walk before admission to the labor unit. Those in the direct admission group were admitted to the labor unit without an assessment. Data were collected and analyzed about method of delivery, duration of labor, intrapartum interventions, and neonatal well-being. Women completed an evaluation of their experience in the early postpartum period. RESULTS: Significant decreases occurred in duration of labor, use of epidural analgesia for pain, and use of oxytocin to augment labor in the early labor assessment group. These women evaluated their labor and birth experience more positively than women in the direct admission group. No significant differences were found in the frequency of cesarean section or instrumental vaginal delivery for the two groups. CONCLUSIONS: Early labor assessment has the potential to reduce the number of women receiving oxytocin for augmentation, the rate of epidural analgesia for pain relief, and the duration of the active and second stages of labor, and to improve women's evaluations of their labor and birth experiences. Options: A: Women were more likely to receive intrapartum oxytocics and analgesia. B: Women reported lower levels of control during labour and birth. C: There were no differences in the rate of caesarean section and other important maternal and neonatal outcomes. D: Women were less likely to receive intrapartum oxytocics and analgesia, and reported higher levels of control during labour and birth.	D
22	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What was the conclusion regarding the effectiveness of routine symphysis-fundal height measurements during antenatal care on pregnancy outcomes? Please answer this question based on the information provided below: The implications of introducing the symphyseal-fundal height-measurement. A prospective randomized controlled trial. A total of 1639 women attending the antenatal clinic of Gentofte University Hospital, Copenhagen, during 1986-1987 was randomized into a symphyseal fundal (SF)-group and a control group. The women in the SF-group had their fundal height measured from the 29th week until delivery. The measurements were used along with the other usual screening procedures. The SF-measurements were not found helpful in the prediction of small-for-gestational-age infants and no significant differences were found between the two groups regarding the number of interventions, additional diagnostic procedures, or the condition of the newborns. Options: A: Symphysis-fundal height measurements significantly improved pregnancy outcomes compared to abdominal palpation alone. B: Symphysis-fundal height measurements significantly worsened pregnancy outcomes compared to abdominal palpation alone. C: There was no significant difference in pregnancy outcomes between symphysis-fundal height measurements and abdominal palpation alone. D: Symphysis-fundal height measurements were found to be harmful and should be avoided during antenatal care.	C
23	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	In preterm or low birth weight infants, what is the impact of gradual versus abrupt discontinuation of supplemental oxygen on the incidence of severe retinopathy of prematurity (ROP)? Please answer this question based on the information provided below: Retinopathy of prematurity (retrolental fibroplasia) and oxygen. I. Clinical study. II. Further observations on the disease. Options: A: Gradual discontinuation significantly reduces the incidence of severe ROP compared to abrupt discontinuation. B: Abrupt discontinuation significantly reduces the incidence of severe ROP compared to gradual discontinuation. C: There is no significant difference in the incidence of severe ROP between gradual and abrupt discontinuation. D: Both methods increase the incidence of severe ROP compared to no supplemental oxygen.	A
24	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	In preterm or low birth weight infants, what were the findings regarding early versus late weaning from supplementary oxygen in terms of neonatal death rates, retinopathy of prematurity, and other long-term outcomes? Please answer this question based on the information provided below: Oxygen administration and retrolental fibroplasia. Response of small premature infants to restriction of supplementary oxygen. Options: A: Early weaning significantly reduced neonatal death rates and retinopathy of prematurity. B: Late weaning significantly reduced neonatal death rates and retinopathy of prematurity. C: There were no significant differences in neonatal death rates or retinopathy of prematurity between early and late weaning. D: Early weaning significantly improved long-term growth, development, lung, and visual function.	C
25	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	In premature infants undergoing extubation, which method is more successful in terms of reducing the likelihood of extubation failure: direct extubation from low rate intermittent positive pressure ventilation (IPPV) or extubation following a period of endotracheal continuous positive airway pressure (CPAP)? Please answer this question based on the information provided below: Successful direct extubation of very low birth weight infants from low intermittent mandatory ventilation rate. It is common practice to use endotracheal continuous positive airway pressure for various time periods up to 24 hours before attempting extubation in infants who are mechanically ventilated. A few studies in newborns have indicated that airway resistance is increased through small endotracheal tubes. This increases the work of breathing and the likelihood of subsequent ventilatory failure. In this study, 27 very low birth weight infants who were 1/2 to 28 days old at the time of extubation were randomly divided into two groups. One group of 13 study infants were extubated directly from intermittent mandatory ventilation rates of six to ten per minute, and the other 14 control infants were placed on continuous positive airway pressure through endotracheal tubes for six hours prior to an attempt to extubate. There was no difference between the two groups in gestational age, postnatal age, weight, or severity of lung disease at the time of extubation. All 13 study infants were successfully extubated without significant apnea or respiratory acidosis. Of the 14 control infants, only seven were successfully extubated; six infants had significant apnea and in one infant respiratory acidosis with pH 7.13 and PCO2 65 developed while receiving continuous positive airway pressure (13/13 v 7/14, P less than .005). The seven infants who failed the preextubation trial of continuous positive airway pressure were later extubated from low intermittent mandatory ventilation rates without significant apnea or respiratory acidosis.(ABSTRACT TRUNCATED AT 250 WORDS) Successful extubation of newborn infants without preextubation trial of continuous positive airway pressure. Sixty newborn infants who had been mechanically ventilated through 3.0- or 3.5-mm endotracheal tubes were studied to examine the necessity of a preextubation trial of continuous positive airway pressure (CPAP). Thirty randomly assigned study infants were directly extubated from intermittent mandatory ventilation rates of six per minute; 30 randomly assigned control infants were extubated after a six-hour trial of continuous positive airway pressure of 3 cm H2O. Changes in respiratory rate, in PCO2, and in PO2/FIO2 were similar. All 30 study infants tolerated direct extubation without significant apnea or respiratory acidosis. Two study and eight control infants developed apnea during six hours after intermittent mandatory ventilation was discontinued (chi 2 = 4.3, P less than .05). Five control and no study infants had apneic episodes greater than or equal to 0.5 per hour (chi 2 = 5.5, P less than .02). The results of this study suggest that newborn infants may tolerate direct extubation from low intermittent mandatory ventilation rates without a preextubation trial of CPAP. A preextubation trial of CPAP appears to be unnecessary and may cause more frequent apnea in newborn infants if used for more than several hours. Does continuous positive airway pressure (CPAP) during weaning from intermittent mandatory ventilation in very low birth weight infants have risks or benefits? A controlled trial. OBJECTIVE: The purpose of this study was to evaluate three ventilator weaning strategies and to evaluate whether the use of continuous positive airway pressure (CPAP) via a nasopharyngeal or endotracheal tube would increase the likelihood of extubation failure in very low birth weight (VLBW) infants. STUDY DESIGN: We studied prospectively 87 preterm infants (mean +/- SD; birth weight: 1078 +/- 188 g; gestational age: 28.8 +/- 2.2 weeks) who were in the process of being weaned from intermittent mandatory ventilation (IMV). Infants were assigned by systematic sampling to one of the following three treatment groups: (1) direct extubation from IMV (D.EXT) (n = 30); (2) preextubation endotracheal CPAP (ET-CPAP) for 12-24 hr (n = 28); or (3) postextubation nasopharyngeal CPAP (NP-CPAP) for 12-24 hr (n = 29). Failure was defined as the need for resumption of mechanical ventilation within 72 hr of extubation due to frequent or severe apnea and/or respiratory failure (pH < 7.25, PaCO2 > 60 mm Hg, and/or requirement for oxygen FiO2 > 60%). RESULTS: There were no significant differences in failure rates among the three procedures. Failures were 2/30 (7%) in D.EXT; 4/28 (14%) in ET-CPAP; and 7/29 (24%) in the NP-CPAP. There were also no differences in FiO2, PaO2, and respiratory rates before and after discontinuation of IMV among the three groups. PaCO2 values were slightly higher in the NP-CPAP group 12-24 hr after weaning from IMV. CONCLUSION: We were unable to demonstrate a clear difference in extubation outcome by use of CPAP administered via an endotracheal or nasopharyngeal tube when compared to direct extubation from low-rate IMV in VLBW infants. Options: A: Direct extubation from low rate IPPV is more successful. B: Extubation following a period of endotracheal CPAP is more successful. C: Both methods are equally successful. D: Neither method is successful in reducing extubation failure.	A
26	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What is the likely effect of dietary fibre supplements on constipation in pregnant women? Please answer this question based on the information provided below: Constipation during pregnancy: dietary fibre intake and the effect of fibre supplementation. Forty women who complained of constipation during the third trimester of pregnancy completed 14-day weighed diet records and bowel function charts over a 4-week period. After 2 weeks of baseline observation the women were randomly allocated into three groups which were asked to take 10 g dietary fibre supplements per day in the form of either a corn-based biscuit (Group A), or as wheat bran (Gp B), or to continue without intervention (Gp C). Mean (+/- s.e.m.) daily dietary fibre intake in the first 2 weeks was similar to that in the general population, at 20.4 +/- 1.2 g, for the whole group, and 21.1 +/- 1.6 g for the 26 women who said they had already increased their dietary fibre intakes in attempts to relieve their symptoms. In the final 2 weeks changes in fibre intakes were: Gp A, mean increase 7.2 +/- 1.0 g per day (P less than 0.001); Gp B, mean increase 9.1 +/- 1.6 g per day (P less than 0.001); Gp C mean decrease 3.50 +/- 1.6 g per day (P less than 0.005). These changes were accompanied by an increase in the number of bowel movements and a change to a softer stool consistency in Gps A and B, with no changes in number of bowel movements or stool consistency in Gp C. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Options: A: Fibre supplements have no significant effect on constipation in pregnant women. B: Fibre supplements decrease the frequency of defaecation and lead to harder stools. C: Fibre supplements increase the frequency of defaecation and lead to softer stools. D: Fibre supplements cause adverse effects and worsen constipation in pregnant women.	C
27	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What are the conclusions regarding the administration of furosemide to premature infants treated with indomethacin for symptomatic patent ductus arteriosus? Please answer this question based on the information provided below: Furosemide does not prevent indomethacin-induced renal side effects in preterm infants. OBJECTIVE: To determine whether furosemide could prevent renal side effects of indomethacin (INN, indometacin) used for the pharmacologic closure of the patent ductus arteriosus (PDA) in preterm infants. METHODS: Thirty-six preterm infants with birth weights < 1750 gm affected by hemodynamically significant PDA were randomly assigned to one of two study groups. Group 1 consisted of 18 infants treated with three doses of indomethacin (0.20 mg/kg every 12 hours); each dose was followed by a dose of furosemide (1 mg/kg). Group 2 consisted of 18 infants treated only with the same doses of indomethacin. Body weight, urine output, glomerular filtration rate (GFR), fractional excretion of sodium (FENa+) and potassium (FEK+), and osmolal and free water clearance were evaluated in both groups before, during, and after treatment. RESULTS: The body weight trend, serum sodium, chloride and potassium concentrations, plasmatic and urinary osmolality were similar during the treatment in both the groups. A significant reduction of urine output (p < 0.01) was detected in group 2 but not in group 1. A significant increase of blood urea nitrogen and serum creatinine was detected at the end of treatment in group 1 compared with group 2. During the treatment, a significantly higher GFR (p < 0.05) was found in group 2 than in group 1. FENa+ and FEK+ were significantly higher (p < 0.05 and p < 0.001, respectively) in group 1 than in group 2 during and after the treatment. The osmolol clearance and free water clearance were significantly higher during and after treatment (p < 0.01 and p < 0.001, respectively) in group 1 than in group 2. CONCLUSIONS: Our findings show that furosemide cannot prevent the indomethacin-induced renal failure, but it does not have any negative influence on its therapeutic effectiveness. [Indomethacin and furosemide in closure of ductus arteriosus]. Furosemide prevents the renal side effects of indomethacin therapy in premature infants with patent ductus arteriosus. To determine if furosemide would prevent the renal side effects of indomethacin therapy in premature infants with patent ductus arteriosus, 19 premature infants were randomized into two groups: nine received indomethacin alone, and ten received indomethacin followed immediately by furosemide. There was no significant difference between the groups in birth weight, gestational age, postnatal age, and in cardiopulmonary or renal status at the time of study. Infants who received indomethacin and furosemide had significantly higher urine output (P less than 0.05), higher FENa and FECl (P less than 0.01), and higher glomerular filtration rate (P less than 0.05) than those of infants who received indomethacin alone. Seven infants in each group responded to indomethacin therapy with disappearance of PDA murmur and improvement of cardiovascular status. The results of this study suggest that furosemide may prevent the renal side effects of indomethacin therapy and yet not affect the efficacy of indomethacin in the closure of a PDA. Options: A: Furosemide significantly increases the risk of failure of ductal closure and is recommended for use. B: Furosemide does not significantly increase the risk of failure of ductal closure, but there is insufficient evidence to support its use. C: Furosemide significantly improves mid-term and long-term outcomes in these infants. D: Furosemide is beneficial for all infants regardless of their initial BUN/creatinine ratio.	B
28	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effectiveness and safety of dopamine compared to dobutamine in the treatment of systemic hypotension in preterm infants? Please answer this question based on the information provided below: Randomized trial comparing dopamine and dobutamine in preterm infants. The aim of this study was to compare the efficacy of two inotropic infusions in treating low BP in preterm neonates. Forty infants with median gestational age 27 weeks (range 23-33) were studied. At trial entry the infants, who all had a systolic BP < 40 mmHg despite receiving a colloid infusion, were randomized to receive either a dopamine or dobutamine infusion. The infusions were commenced at a rate of 5 micrograms/kg per min and, if necessary, this was increased over the 3 h study period to 15 micrograms/kg per min. There was no significant difference in the gestational or postnatal age or baseline BP of the 20 infants who received dopamine and those 20 who received dobutamine. Three hours after commencing the infusions, although there was no difference in the rate of inotrope infusion between the two groups, the infants who received dopamine had a significantly higher systolic BP, a median of 39 mmHg (range 30-58) compared to a median of 34 mmHg (range 21-46) in the dobutamine group, P < 0.05. In addition, 10 infants who received dopamine, but only 3 who received dobutamine, had a systolic BP > 40 mmHg (P < 0.05). We conclude that dopamine rather than dobutamine infusion is more efficacious in improving the BP of preterm neonates. Impact on blood pressure and intestinal perfusion of dobutamine or dopamine in hypotensive preterm infants. In a prospective study hemodynamic effects of dobutamine or dopamine (10 micrograms/kg/min) were investigated in 20 preterm infants who had protracted arterial hypotension refractory to volume therapy. Doppler ultrasonography of the superior mesenteric artery (SMA) was applied to verify intestinal perfusion and blood pressure was recorded in parallel. Mean arterial pressure (MAP) raised significantly in both groups (from 31.0 +/- 6.8 to 37.7 +/- 9.8 mm Hg during dobutamine and from 27.7 +/- 3.6 to 36.0 +/- 9.3 mm Hg during dopamine). Mean blood flow velocity increased from 25.8 +/- 13.5 to 31.5 +/- 16 cm/s with dobutamine and from 16.3 +/- 5.0 to 19.0 +/- 6.0 cm/s with dopamine (significant for dobutamine). Vascular resistance of SMA (indicated by resistance index; RI) decreased from 0.81 +/- 0.07 to 0.74 +/- 0.11 for dobutamine and from 0.89 +/- 0.06 to 0.79 +/- 0.07 for dopamine (significant for both groups). These data indicate that in the dose tested here both catecholamines are equally effective in raising MAP and lead to a significant increase of intestinal perfusion. Thus, a negative impact on mesenteric blood supply, predisposing to necrotizing enterocolitis, is not probable. Randomized, blind trial of dopamine versus dobutamine for treatment of hypotension in preterm infants with respiratory distress syndrome. To compare the efficacy of dopamine and dobutamine for the treatment of hypotension (mean arterial blood pressure, < or = 30 mm Hg) in preterm (< or = 34 weeks of gestation) infants with respiratory distress syndrome in the first 24 hours of life, we enrolled 63 hypotensive preterm infants in a randomized, blind trial. Inclusion criteria required an arterial catheter for measurement of mean arterial blood pressure, treatment with exogenous surfactant, and persistent hypotension after volume expansion with 20 ml/kg (packed erythrocytes if hematocrit < 0.40, 5% albumin if > or = 0.40). Intravenous study drug infusions were initiated at 5 micrograms/kg per minute and then increased in increments of 5 micrograms/kg per minute at 20-minute intervals until a mean arterial blood pressure > 30 mm Hg was attained and sustained for > or = 30 minutes (success) or a maximum rate of 20 micrograms/kg per minute was reached without resolution of hypotension (failure). The study groups at entry were comparable for birth weight, gestational age, postnatal age, gender, birth depression, hematocrit < 0.40, heart rate, oxygenation index, delivery route, maternal chorioamnionitis, and maternal magnesium or ritodrine therapy. No infants in the dopamine group had a treatment failure (0/31; 0%); (16%) of 32 infants failed to respond to dobutamine (p = 0.028). Success was attained at < or = 10 micrograms/kg per minute in 30 (97%) of 31 infants given dopamine and in 22 (69%) of 32 infants given dobutamine (p < 0.01). Among those treated successfully, the increase in mean arterial blood pressure was significantly higher in those given dopamine (mean, 11.3 vs 6.8 mm Hg; p = 0.003). We conclude that dopamine is more effective than dobutamine for the early treatment of hypotension in preterm infants with respiratory distress syndrome. Response to dobutamine and dopamine in the hypotensive very preterm infant. A randomised double blind study was designed to evaluate haemodynamic response to dobutamine and dopamine in 20 hypotensive preterm infants of less than 32 weeks' gestation. Neonates initially received dopamine or dobutamine 5 micrograms/kg/min. If mean arterial pressure (MAP) remained below 31 mm Hg, the infusion rate was increased in increments of 5 micrograms/kg/min. If 20 micrograms/kg/min of the initial drug failed to achieve a MAP above 30 mm Hg, it was discontinued and the other drug was administered at the same infusion rate. Left ventricular output (LVO) was measured by pulsed Doppler echocardiography. Mean (SE) MAP increased significantly from 24.4 (1.0) to 32.0 (1.4) mm Hg at a median dobutamine dosage of 20 micrograms/kg/min and from 25.6 (1.2) to 37.7 (1.5) mm Hg at a median dopamine dosage of 12.5 micrograms/kg/min. The percentage LVO increase was +21 (7)% with dobutamine compared with -14 (8)% with dopamine. Dobutamine failed to increase MAP above 30 mm Hg in six infants out of 10, whereas dopamine succeeded in all 10 infants. Six switches from dobutamine to dopamine were thus performed, providing a rise in MAP (29.2 (0.5) to 41.2 (2.0) mm Hg) and drop in LVO (356 (40) to 263 (36) ml/kg/min). These data indicate that dopamine is more effective than dobutamine in raising and maintaining MAP above 30 mm Hg; however dopamine does not increase LVO. Assessment of therapy for arterial hypotension in critically ill preterm infants. The aim of this paper is to assess the efficacy of albumin and dopamine compared with albumin and dobutamine in treating hypotension in preterm newborn infants (PNI). A randomized, open-label, prospective, cross-over study, was designed on 66 PNI whose weights were between 1,000 to 1,500 g, and persistent hypotension, defined as a mean arterial pressure (MAP) of < 30 mmHg. Infants were randomly allocated to two groups and received a 5% albumin infusion at a dosage of 20 mL/kg, in 30 min. Thereafter, one group received dopamine and the other dobutamine at doses of 5 microg/kg/min. If there was not an increase in MAP values > 30 mmHg, the infusions were increased every 20 min by 2.5 microg/kg/min, up to a maximum of 10 microg/kg/min. Treatment failure was considered when there was no pressure response within 2 hr after the infusion started; then patients were changed to the other catecholamine. Statistical analysis was done with student's t-test, x2, and Fisher's exact probability test. There were no differences between groups in initial features. Overall, MAP was normalized with dopamine in 29 of 33 infants and with dobutamine in 25 of 33 infants (p > 0.05). The initial dosage of 5 microg/kg/min, was adequate in 22 infants treated with dopamine and in 13 treated with dobutamine (p < 0.05). The change from dopamine to dobutamine was successful in three out of four patients, while changing from dobutamine to dopamine was adequate in seven out of eight patients. Dopamine is recognized as the drug of choice to treat hypotension in PNI. Since our results showed only small differences in responses, it is proposed that dobutamine is also as efficacious and useful as dopamine. Options: A: Dopamine was more effective than dobutamine in treating systemic hypotension, with fewer infants experiencing treatment failure, but there was no significant difference in neonatal mortality, incidence of severe periventricular haemorrhage, or incidence of tachycardia. B: Dobutamine was more effective than dopamine in treating systemic hypotension, with fewer infants experiencing treatment failure, and there was a significant difference in neonatal mortality favoring dobutamine. C: There was no significant difference between dopamine and dobutamine in treating systemic hypotension, neonatal mortality, incidence of severe periventricular haemorrhage, or incidence of tachycardia. D: Dopamine was less effective than dobutamine in treating systemic hypotension, with more infants experiencing treatment failure, and there was a significant difference in the incidence of tachycardia favoring dopamine.	A
29	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effects of dietary advice to alter salt intake during pregnancy on the risk of pre-eclampsia and its consequences? Please answer this question based on the information provided below: (Patho)physiological implications of chronic dietary sodium restriction during pregnancy; a longitudinal prospective randomized study. OBJECTIVE: To study the possible pathophysiological implications of long continued dietary sodium restriction in pregnancy. DESIGN: Longitudinal prospective randomized study of the effects of a low sodium diet compared with unrestricted sodium intake in pregnancy. SETTING: Academic Department of Obstetrics and Gynaecology at Sint Radboud Hospital, Nijmegen, The Netherlands. SUBJECTS: 42 healthy nulliparous women. INTERVENTION: A low sodium diet (20 mmol sodium daily) started in the 14th week of pregnancy and stopped after delivery. MAIN OUTCOME MEASURES: Maternal weight gain, food intake, blood pressure, cardiac output, systemic vascular resistance, haematocrit and birthweight. RESULTS: Total maternal weight gain and dietary energy intake during pregnancy and weight at 1 and 6 weeks postpartum were significantly lower in the low sodium group. Blood pressure during pregnancy did not show major differences. Stroke volume and cardiac output during pregnancy were significantly lower in the low sodium group whereas systemic vascular resistance was significantly higher. Haematocrit values in the low sodium group tended to be lower during pregnancy, but were significantly lower at 1 and 6 weeks postpartum than in the unrestricted group. Placental and birthweights were not significantly different between the two groups. CONCLUSIONS: Chronic dietary sodium restriction during pregnancy is characterized by a diminished body fat accumulation and a reduction in circulating volume, due to a decrease in both plasma and red cell volume, in combination with a high systemic vascular resistance without major effects on blood pressure and birthweight. Low sodium diet in pregnancy: effects on maternal nutritional status. In the present study, besides the effect on blood pressure, the effects of a low sodium diet in pregnancy on maternal energy and nutrient intake, calcium metabolism, zinc and magnesium status, weight gain and body fat storage were investigated. No effect of the low sodium diet in pregnancy on the course of blood pressure and the incidence of hypertensive disorders was observed. The reduction in sodium intake also caused a significant reduction in the intake of energy, protein, carbohydrates, fat, calcium, zinc, magnesium, iron and cholesterol. The reduced intake of calcium, zinc and magnesium in the women on the low sodium diet did not result in significant changes in circulating total calcium, ionized calcium, parathyroid hormone, zinc, alkaline phosphatase or magnesium, probably because of homeostatic adaptations by the kidneys. In the women on the low sodium diet non-significant reductions in weight gain (1.5 kg) and fat mass gain (0.9 kg) over pregnancy were observed. These reductions in weight and fat mass gain were more pronounced (3.4 kg (P = 0.003) and 1.3 kg (P = 0.15), respectively) when only the data of the women with good compliance were analyzed. The use of a low sodium diet in pregnancy did not have significant effects on infant birth weight, placental weight or other pregnancy outcome variables. Dietary sodium restriction in the prophylaxis of hypertensive disorders of pregnancy: effects on the intake of other nutrients. Dietary sodium restriction is used in the Netherlands in the prophylaxis of preeclampsia. To study the effects of long-term sodium restriction on the intake of other nutrients and the outcome of pregnancy, 68 healthy nulliparous pregnant women were randomly assigned to either a low-sodium diet (20 mmol/24 h) or an unrestricted diet. The diet was consumed between week 14 of gestation and delivery. The dietary intakes of energy, fat, protein, carbohydrate, sodium, potassium, and calcium were estimated with the dietary-history technique. A low-sodium diet reduced the intake of protein (by approximately 15 g/24 h), fat (by 20 g/24 h), and calcium (by 350 mg/24 h) and tended to decrease the energy intake (by approximately 0.7 MJ/24 h). The intakes of carbohydrate and potassium did not differ between the groups. The maternal weight gain was less in the low-sodium group (6.0 +/- 3.7 compared with 11.7 +/- 4.7 kg). Mean birth weight was not significantly different (3.2 +/- 0.5 compared with 3.4 +/- 0.5 kg). Vasopressin and oxytocin levels during normal pregnancy: effects of chronic dietary sodium restriction. Neurohypophysial hormones are thought to be involved in alterations in fluid balance during pregnancy and delivery. In the course of normal pregnancy intravascular volume is increased whereas sodium restriction is thought to reduce plasma volume and cardiac output. In the present study, we measured the effect of long-term severe sodium restriction on vasopressin (AVP) and oxytocin (OT) levels during normal pregnancy and after delivery. Fifty-nine healthy nulliparous women were randomized either for a low sodium diet (20 mmol sodium daily) or for a normal diet from week 12 of pregnancy onwards. Circulating plasma levels and urinary excretion of AVP and OT, their neurophysins (Np-AVP and Np-OT) and AVP bound to platelets were determined at regular intervals during pregnancy and after delivery. After completion of the study, women on a sodium-restricted diet were compared with control women on a normal diet using repeated measurement ANOVA with adjustment for potentially confounding variables. After randomization, a reduction in urinary sodium excretion of, on average, 40-82% was found. In general, no effect of sodium restriction could be demonstrated on the various parameters (0.53 < P < 0.98) with the exception of a significantly lower 24-h urinary AVP excretion by non-smokers with sodium restriction compared with non-smokers having a normal diet (P = 0.018). For all parameters, clear changes were found in the course of pregnancy and puerperium (P < 0.0001 to P < 0.005). Platelet-bound AVP decreased and Np-OT increased during pregnancy. After birth, free plasma AVP, platelet-bound AVP, OT, osmolality, sodium and potassium increased, while Np-AVP and Np-OT decreased. Although elevated Np-AVP and Np-OT levels during pregnancy seem to indicate increased release of neurohypophysial hormones, pregnancy up to 36 weeks of gestation is accompanied by low circulating AVP and OT levels. Long-term severe sodium restriction diminishes urinary AVP excretion in (non-smoking) pregnant women, without changing circulating levels of AVP and OT, despite the known reduction in circulating volume. The reduced circulating (platelet-bound) AVP levels during pregnancy, whether or not in combination with severe sodium restriction, support the absence of significant non-osmotic stimulation of AVP during pregnancy. Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial. OBJECTIVE: To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. DESIGN: Multi-centre randomised controlled trial between April 1992 and April 1994. SETTING: Seven practices of independent midwives and one university hospital. PARTICIPANTS: The experimental group comprised 184 women given a low sodium diet (< or = 50 mmol sodium/day) and a control group of 177 women given a normal diet. Eligible women for inclusion had had a rise of blood pressure, or excessive weight gain or oedema during the antenatal period. The 361 women in the trial were recruited from 2020 nulliparae, of whom 1512 (75%) gave informed consent at the beginning of their pregnancy to participate in the study. MAIN OUTCOME MEASURES: The difference between highest diastolic blood pressure after randomisation and diastolic blood pressure at the moment of randomisation; referral and admission to hospital for hypertension. RESULTS: There was no difference in increase of diastolic blood pressure after randomisation, the percentage of referral and admission to hospital for hypertension, or in obstetric outcome between the two groups. Urinary sodium excretion after randomisation in the normal diet group was significantly higher than in the low sodium group. CONCLUSION: Prescribing a sodium-restricted diet to prevent or to treat mild pregnancy-induced hypertension is not effective. Therefore there is no need to introduce a salt restricted diet in prenatal care, although increasing evidence shows that a low sodium diet prevents hypertension in non-pregnant individuals. Options: A: The trials provided strong evidence that reducing salt intake significantly decreases the risk of pre-eclampsia. B: The trials provided strong evidence that increasing salt intake significantly decreases the risk of pre-eclampsia. C: The trials provided insufficient evidence to determine the effects of altering salt intake on the risk of pre-eclampsia. D: The trials showed that altering salt intake has no effect on the risk of pre-eclampsia.	C
30	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What were the findings regarding the effects of plasma volume expansion for the treatment of women with pre-eclampsia? Please answer this question based on the information provided below: Haemodynamic changes in gestational proteinuric hypertension: the effects of rapid volume expansion and vasodilator therapy. Ten patients with gestational proteinuric hypertension were studied with a Swan-Ganz thermodilution haemodynamic catheter before, during and after plasma volume expansion. Five patients were treated with dihydralazine before volume expansion and five after volume expansion. Before treatment all patients had a low pulmonary capillary wedge pressure (PCWP), low cardiac index (CI) and high systemic vascular resistance (SVR). Following volume expansion the PCWP and CI increased, the SVR decreased but the blood pressure (BP) was unchanged. Administration of dihydralazine following volume expansion led to a decrease in PCWP, an increase in CI and a decrease in SVR and BP. Dihydralazine alone caused an increase in heart rate, PCWP, and CI, and a decrease in SVR and BP. Volume expansion, by increasing CI and decreasing SVR, may be of therapeutic benefit in the severely hypertensive pregnant patient with a low cardiac index. Plasma volume expansion in the treatment of pre-eclampsia. The effects of plasma volume expansion with hyperosmolar solutions with the use of dextran 40 and plasmanate were studied in a controlled manner in 32 primiparous pre-eclamptic patients. The patients who were being studied received either dextran 40 (Rheomacrodex) or plasmanate in addition to the routine treatment with sedatives, bed rest, and magnesium sulfate when indicated. The patients were randomly assigned by blind draw to control (13), dextran (10), and plasmanate (nine) groups. The renal status of all patients was evaluated prior to volume expansion therapy. Patients were monitored for blood pressure, proteinuria, output of urine, hematocrit, and creatinine clearance. There was significant improvement in hemoconcentration and output of urine, and a trend toward a lowering of the mean arterial blood pressure in patients who were receiving plasmanate or dextran for volume expansion. Options: A: Plasma volume expansion significantly improved maternal and fetal outcomes. B: Plasma volume expansion had no significant effect on maternal and fetal outcomes. C: There is insufficient evidence to determine the effects of plasma volume expansion on maternal and fetal outcomes. D: Plasma volume expansion significantly worsened maternal and fetal outcomes.	C
31	evidence_summarization	You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.	What was the effect of a policy of elective delivery compared to expectant management in term diabetic pregnant women on maternal and perinatal outcomes? Please answer this question based on the information provided below: Insulin-requiring diabetes in pregnancy: a randomized trial of active induction of labor and expectant management. OBJECTIVE: Our purpose was to assess whether a program of expectant management of uncomplicated pregnancies in mothers with insulin-requiring gestational or pregestational class B reduces the incidence of cesarean birth. STUDY DESIGN: Two hundred women with uncomplicated, insulin-requiring diabetes at 38 weeks' gestation who were compliant with care and whose infants were judged appropriate for gestational age were randomly assigned to (1) active induction of labor within 5 days or (2) expectant management. The expectant management group was monitored with weekly physical examination and twice-weekly nonstress tests and amniotic fluid volume estimation until delivery. RESULTS: Expectant management increased the gestational age at delivery by 1 week. Approximately half (49%) of the mothers in the expectant management group required induction of labor for obstetric indications. The cesarean delivery rate was not significantly different in the expectant management group (31%) from the active induction group (25%). The mean birth weight (3672 +/- 407 gm) and percentage large for gestational age, as defined by birth weight > or = 90th percentile, of infants in the expectantly managed group (23%) was greater than those in the active induction group (3466 +/- 372 gm, p < 0.0001, 10% large for gestational age). This difference persisted after controlling for gestational age and maternal age and body weight (p < 0.01). CONCLUSION: In women with uncomplicated insulin-requiring gestational or class B pregestational diabetes, expectant management of pregnancy after 38 weeks' gestation did not reduce the incidence of cesarean delivery. Moreover, there was an increased prevalence of large-for-gestational-age infants (23% vs 10%) and shoulder dystocia (3% vs 0%). Because of these risks, delivery should be contemplated at 38 weeks and, if not pursued, careful monitoring of fetal growth must be performed. Insulin-requiring diabetes in pregnancy: a randomized trial of active induction of labor and expectant management. OBJECTIVE: Our purpose was to assess whether a program of expectant management of uncomplicated pregnancies in mothers with insulin-requiring gestational or pregestational class B reduces the incidence of cesarean birth. STUDY DESIGN: Two hundred women with uncomplicated, insulin-requiring diabetes at 38 weeks' gestation who were compliant with care and whose infants were judged appropriate for gestational age were randomly assigned to (1) active induction of labor within 5 days or (2) expectant management. The expectant management group was monitored with weekly physical examination and twice-weekly nonstress tests and amniotic fluid volume estimation until delivery. RESULTS: Expectant management increased the gestational age at delivery by 1 week. Approximately half (49%) of the mothers in the expectant management group required induction of labor for obstetric indications. The cesarean delivery rate was not significantly different in the expectant management group (31%) from the active induction group (25%). The mean birth weight (3672 +/- 407 gm) and percentage large for gestational age, as defined by birth weight > or = 90th percentile, of infants in the expectantly managed group (23%) was greater than those in the active induction group (3466 +/- 372 gm, p < 0.0001, 10% large for gestational age). This difference persisted after controlling for gestational age and maternal age and body weight (p < 0.01). CONCLUSION: In women with uncomplicated insulin-requiring gestational or class B pregestational diabetes, expectant management of pregnancy after 38 weeks' gestation did not reduce the incidence of cesarean delivery. Moreover, there was an increased prevalence of large-for-gestational-age infants (23% vs 10%) and shoulder dystocia (3% vs 0%). Because of these risks, delivery should be contemplated at 38 weeks and, if not pursued, careful monitoring of fetal growth must be performed. Options: A: Elective delivery significantly reduced the risk of caesarean section. B: Elective delivery significantly reduced the risk of macrosomia. C: Elective delivery significantly increased the risk of maternal morbidity. D: Elective delivery had no impact on the risk of shoulder dystocia.	B

End of preview. Expand in Data Studio

TrialPanorama: Supervised Fine-Tuning Data for Clinical Research LLMs

Dataset Summary

TrialPanorama SFT is a large-scale, task-oriented supervised fine-tuning (SFT) dataset designed to train large language models for end-to-end clinical research and trial development workflows.

The dataset is derived from TrialPanorama, a structured clinical research resource aggregating 1.6M+ clinical trial records across global registries and linking them with biomedical ontologies and supporting literature. It focuses on transforming raw clinical trial data and curated evidence into instruction–response pairs that reflect realistic, expert-level research tasks.

The dataset supports training LLMs to operate as clinical research assistants capable of systematic literature review, trial design reasoning, and evidence-based decision making.

Supported Training Tasks

Each task is released as a separate dataset configuration.

Task (config)	Description
`study_search`	Given a clinical research question, retrieve and justify relevant studies from large trial and literature corpora.
`study_screening`	Perform inclusion/exclusion decisions for candidate studies based on eligibility criteria and study metadata.
`evidence_summarization`	Synthesize structured and unstructured trial evidence into concise, faithful summaries.
`trial_design`	Generate or refine clinical trial designs, including arms, interventions, and eligibility criteria.
`sample_size_estimation`	Estimate appropriate sample sizes under specified statistical and design assumptions.
`trial_completion_assessment`	Assess trial completion likelihood and rationalize risks using trial design and historical evidence.

Data Characteristics

Instruction-following format suitable for SFT
Grounded in real clinical trial records
Emphasizes clinical reasoning, not surface text generation
Covers both systematic review and trial design & optimization tasks
Designed to support generalist and agentic LLM training

All files are provided in Apache Parquet format.

Typical Fields

Each record may include:

Task-specific instruction or prompt
Structured context (trial metadata, eligibility criteria, outcomes, phase)
Model response targets written or validated by domain experts
Task and difficulty metadata

Exact schemas vary by task.

Intended Use

This dataset is intended for:

Supervised fine-tuning of LLMs for clinical research tasks
Training research-oriented AI agents for trial planning and evidence synthesis
Building domain-adapted models for systematic review automation
Academic benchmarking of clinical reasoning capabilities

Not Intended For

Model evaluation (see TrialPanorama benchmarks for evaluation)
Clinical decision making
Direct medical or regulatory use

How to Load

Load a specific training task via its configuration name:

from datasets import load_dataset

ds = load_dataset("TrialPanorama/dataset", "study_screening")
ds["train"]

Downloads last month: 6

Size of downloaded dataset files:

499 MB

Size of the auto-converted Parquet files:

499 MB

Number of rows:

145,872