Francisco L. Gaudier

Misoprostol for cervical ripening and labor induction : A meta-analysis

Objective To analyze published randomized trials assessing the safety and efficacy of misoprostol for cervical ripening and labor induction. Data Sources We supplemented a search of entries in electronic data bases with references cited in original studies and review articles to identify randomized trials of misoprostol for cervical ripening and labor induction. Methods of Study Selection Two blinded investigators performed independent trial quality evaluation and data abstraction of randomized clinical trials assessing the efficacy of misoprostol as a cervical ripening and labor-inducing agent. Tabulation, Integration, and Results We calculated an estimate of the odds ratio (OR) and risk difference for dichotomous outcomes, using both a random- and fixedeffects model. Continuous outcomes were pooled using a variance-weighted average of the within-study difference in means. Of 16 studies identified, eight met our criteria for meta-analysis. These eight trials included 966 patients (488 received misoprostol and 478 were controls). Women who received misoprostol for cervical ripening and labor induction had a significantly lower overall cesarean rate (OR 0.67, 95% confidence interval [CI] 0.48, 0.93) and a higher incidence of vaginal delivery within 24 hours of misoprostol application (OR 2.64, 95% CI 1.87, 3.71). Use of misoprostol was associated with a higher incidence of tachysystole (OR 2.70, 95% CI 1.80, 4.04) but not hyperstimulation (OR 1.91, 95% CI 0.98, 3.73). The incidences of abnormal 5-minute Apgar scores and admissions to the neonatal intensive care unit were similar in the misoprostol and control groups. The pooled estimate of the mean interval from start of induction to delivery was 4.6 hours fewer (95% CI −3.5, −5.7) in the misoprostol group. Conclusions Published data confirm the safety and efficacy of intravaginal misoprostol as an agent for cervical ripening and labor induction.

Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: A randomized trial

Objective To compare the safety, efficacy, and costs of intravaginal misoprostol versus dinoprostone vaginal inserts for cervical ripening and labor induction. Methods Two hundred twenty-three labor induction patients were assigned randomly to one of two treatment groups: 1) intravaginal misoprostol or 2) dinoprostone vaginal inserts. Fifty micrograms of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum period of 24 hours. Ten milligrams of dinoprostone was administered in a single application as a vaginal insert for 12 hours. Results Among 223 patients evaluated, 108 were allocated to the misoprostol group and 115 to the dinoprostone group. The median interval from induction to vaginal delivery was significantly shorter in the misoprostol group: 698 (range 395–1053) versus 1041 (range 792–1531) minutes (P < .001). Vaginal delivery within 12 hours of ripening occurred in 40.7% of patients who received misoprostol compared with 19.1% for those receiving dinoprostone (P < .001); no significant difference between the groups was noted for vaginal delivery within 24 hours. Uterine tachysystole occurred more frequently in patients in the misoprostol group (21.3%) than in the dinoprostone group (7.0%) (P = .004). Nevertheless, no statistically significant differences were noted between the groups with respect to intrapartum complications, including uterine hyperstimulation, mode of delivery, and neonatal or maternal adverse outcomes. The average cost per patient for misoprostol treatment was

Efficacy of maintenance therapy after acute tocolysis : A meta-analysis

85 compared with

Randomized trial of two doses of the prostaglandin E1 analog misoprostol for labor induction

606 for treatment with the vaginal insert. Conclusion Intravaginal misoprostol and the dinoprostone vaginal insert appear to be safe agents for cervical ripening and labor induction. However, misoprostol is less expensive and more effective than the dinoprostone vaginal insert.

Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study.

OBJECTIVE Our purpose was to analyze published randomized trials assessing the efficacy of maintenance tocolytic therapy after short-term tocolysis in patients with acute preterm labor. STUDY DESIGN We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify randomized trials assessing the efficacy of maintenance tocolytic therapy after resolution of the acute preterm labor episode. Two masked investigators performed independent trial quality evaluation and data abstraction of each trial. We calculated an estimate of the odds ratio and risk difference for dichotomous outcomes, using both a random- and fixed-effects model. Continuous outcomes were pooled with a variance-weighted average of the within-study difference in means. RESULTS Of 17 studies identified, 12 met our criteria for meta-analysis. These 12 trials included 1590 patients, including 855 who received maintenance tocolysis and 735 comparison patients who received placebo or no maintenance treatment. Compared with placebo or no treatment, the pooled odds ratio for preventing preterm delivery was 0.95 (95% confidence interval, 0. 77-1.17), and the odds ratio for preventing recurrent preterm labor was 0.81 (95% confidence interval, 0.64-1.03). In addition, use of maintenance tocolytic therapy was not associated with decreased rates of neonatal respiratory distress syndrome, perinatal deaths, or differences in birth weight. Although no difference was noted in mean gestational age at delivery, those receiving tocolytic agents had a longer latency period. CONCLUSION Maintenance tocolytic therapy after successful treatment of an acute episode of preterm labor does not reduce the incidence of recurrent preterm labor or preterm delivery and does not improve perinatal outcome. Accordingly, the results of this meta-analysis do not support the use of maintenance tocolytic therapy after successful treatment of preterm labor.

Intrapartum amnioinfusion for meconium-stained fluid: meta-analysis of prospective clinical trials.

OBJECTIVE Our purpose was to compare the safety and effectiveness of intravaginally administered misoprostol at doses of 25 micrograms and 50 micrograms for indicated labor induction in patients with an unfavorable cervix. STUDY DESIGN Three hundred ninety-nine patients received either 25 micrograms or 50 micrograms of misoprostol, placed intravaginally in the posterior fornix, in this randomized double-blind trial. The dose was repeated every 3 hours until adequate labor was achieved (at least three contractions in 10 minutes). RESULTS Among 399 patients evaluated, 192 patients were allocated to the 25 micrograms group and 207 patients to the 50 micrograms group. The start-to-delivery interval was shorter in the 50 micrograms group (826 minutes vs 970 minutes, p = 0.02). The incidence of vaginal delivery after one dose was higher in the 50 micrograms group (38.2% vs 25.0%, p = 0.007). Patients receiving 25 micrograms required oxytocin augmentation more frequently than did those receiving 50 micrograms (27.1% vs 16.9%, p = 0.02). No differences were noted in the cesarean or other operative delivery rates among patients in the two treatment groups. The incidence of newborns with a cord pH < 7.16 was greater in the 50 micrograms group (13.0% vs 6.8%, p = 0.04). Although the incidence of hyperstimulation was similar between the groups, the incidence of tachysystole was higher in the 50 micrograms group (32.8% vs 15.6%, p = 0.0001). CONCLUSIONS Although a dose of 50 micrograms is associated with a shorter start-to-delivery interval and a higher incidence of vaginal delivery after one dose, 25 micrograms of intravaginal misoprostol is effective and associated with a lower incidence of tachysystole and cord pH values < 7.16.

Group B streptococcus colonization in pregnant diabetic women.

Objective To evaluate the safety and clinical effectiveness of intravaginal misoprostol, a synthetic prostaglandin, E1 analogue, for labor induction in gravidas with premature rupture of membranes (PROM) at term. Methods One hundred forty-one pregnant women with term PROM were assigned randomly to one of two induction groups: 1) intravaginal misoprostol or 2) intravenous oxytocin by continuous infusion. Results Seventy subjects were allocated to the misoprostol group and 71 to be oxytocin group. The mean (± standard deviation) interval from induction to delivery was significantly shorter in the misoprostol group (416 ± 276 compared with 539 ± 372 minutes; P = .04). In 85.7% of patients in the misoprostol group, only one dose was required. Intrapartum complication rates, mode of delivery, and neonatal or maternal adverse event rates were similar in the two treatment groups. Uterine tachysystole occurred more frequently with misoprostol than with oxytocin (28.6% compared with 14.0%; P < .04). Conclusion Intravaginal administration of misoprostol induces labor safely and effectively in patients with PROM at term.

Cervical ripening and labor induction with a controlled-release dinoprostone vaginal insert: a meta-analysis.

Objective To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid. Data Sources We identified prospective clinical trials of amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid (AF) published in English by using computerized databases, references in published studies, and index reviews. Methods of Study Selection We analyzed prospective studies of intrapartum amnioinfusion for meconium-stained AF. In every case, group allocation was based exclusively on meconium in AF. Only published studies with clearly documented outcome data were included. The trials were evaluated for meconium below the vocal cords, meconium aspiration syndrome, fetal acidemia, cesarean delivery, and postpartum endometritis. Each trial was evaluated for the quality of its methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. Tabulation, Integration, and Results Thirteen studies met inclusion criteria for our systematic review. Odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated for each outcome. Estimates of ORs and risk differences for dichotomous outcomes were calculated using random and fixed-effects models. We tested for homogeneity across the studies. We found that intrapartum amnioinfusion significantly reduced the frequency of meconium aspiration syndrome (OR 0.30; 95% CI 0.19, 0.46), of meconium below the vocal cords, and neonatal acidemia. Subjects allocated to receive amnioinfusion also had a significantly lower overall cesarean rate (OR 0.74, 95% CI 0.59, 0.93) without increased postpartum endometritis. Conclusion Amnioinfusion in cases of meconium-stained fluid significantly improves neonatal outcome, lowers the cesarean delivery rate, and does not increase the postpartum endometritis rate.

Prophylactic amnioinfusion for intrapartum oligohydramnios: a meta-analysis of randomized controlled trials

Objective To evaluate the influence of maternal diabetes on the risk of group B streptococcus colonization during pregnancy. Methods We prospectively analyzed data on 105 pregnant women with diabetes mellitus, both pregestational and gestational, and a control group of 300 pregnant women without carbohydrate intolerance. All had singleton gestations, negative tests for human immunodeficiency virus, and intact membranes at enrollment. Culture specimens for group B streptococcus were obtained from the lower vaginal walls and rectum. Two-tailed unpaired Student t test, Mann-Whitney U test, and χ2 test were used as appropriate. Multiple logistic regression analyses were performed to evaluate the independent influence of maternal diabetes on the rate of group B streptococcus colonization. Results Compared to controls, diabetic women had a higher colonization rate (43.8 versus 22.7%, odds ratio [OR] 2.56, 95% confidence interval [CI] 1.6, 4.1). The prevalence of group B streptococcus colonization in pregestational diabetic women was 54.1% and in women with gestational diabetics it was 35.1% (P = .05). Among women with pregestational diabetes, the prevalence of group B streptococcus colonization was 59.1% in class B and 50.0% in class C to R (P = not significant). After we adjusted fir maternal age, race, and obesity, diabetic women continued to be at increased risk of group B streptococcus colonization (OR 3.1, 95% CI 1.8, 5.2). Conclusion Carbohydrate intolerance appears to be an independent risk factor for group B streptococcus colonization during pregnancy.

Use of misoprostol (prostaglandin E1 methyl analogue) to expedite delivery in severe preeclampsia remote from term

OBJECTIVE To systematically review published randomized trials that compared efficacy of a 10-mg, controlled-release dinoprostone vaginal insert with other prostaglandins for cervical ripening and labor induction. DATA SOURCES We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify randomized clinical trials of dinoprostone vaginal inserts for cervical ripening and labor induction. METHODS OF STUDY SELECTION We evaluated, abstracted data, and assessed the quality of randomized clinical trials on the efficacy of dinoprostone vaginal inserts as cervical ripening and labor induction agents. Only published randomized trials were included in this meta-analysis. TABULATION, INTEGRATION, AND RESULTS Seventeen studies were identified, eight of which met our criteria for metaanalysis. Those eight trials included 964 subjects, 490 of whom were allocated to dinoprostone vaginal inserts and 474 to other prostaglandin (PG) preparations. We calculated an estimate of the odds ratio (OR) and risk difference for dichotomous outcomes, using a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of within-study difference in means. Compared with women who received other PG preparations, those who received dinoprostone vaginal inserts had lower incidence of vaginal delivery within 12 hours of PG application (OR 0.55, 95% confidence interval 0.39, 0.79). Vaginal inserts were associated with longer intervals to vaginal delivery and lower rates of active labor. There were no differences in cesarean delivery rates, incidence of hyperstimulation, or need for oxytocin augmentation between dinoprostone and other PGs. CONCLUSION Dinoprostone vaginal insert was less effective than other prostaglandins for cervical ripening and labor induction.