MISOPROSTOL INDUCTION OF LABOR IN MULTIPARA PREGNANT WOMEN: A MINI-SURVEY FOR PREDICTORS OF OUTCOME. (original) (raw)
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American Journal of Obstetrics and Gynecology, 2005
Objective: The purpose of this study was to identify the maximum tolerable dose and to determine the efficacy of different misoprostol dose reservoirs in an intravaginal controlledrelease hydrogel polymer. Study design: Nulliparous women at R37 weeks' gestation requiring cervical ripening and induction of labor were treated with misoprostol in a controlled-release, retrievable hydrogel polymer vaginal insert. Sequential cohorts of 6 patients were to be treated with escalating dose reservoirs of 25, 50, 100, 200, and 300 mg. The insert was to be removed upon onset of active labor, at 24 hours, or earlier if treatment-related adverse events occurred. The safety end point was determination of the maximum tolerable dose (MTD) based on occurrence of hyperstimulation syndrome. Our primary efficacy end point was time to vaginal delivery. Results: Increasing reservoir doses of misoprostol up to 100 mg produced more rapid increases in modified Bishop scores, less need for oxytocin, and a shorter time to vaginal delivery. Doses above 100 mg did not further enhance cervical ripening or shorten time to vaginal delivery. The median time to vaginal delivery was 14.2 hours using the 100 mg dose. Uterine hyperstimulation and adverse fetal heart rate effects occurred with the 200 and 300 mg inserts. Conclusion: The 100 mg vaginal insert resulted in successful cervical ripening and rapid vaginal delivery with an acceptable safety profile for future randomized clinical trials.
Labor induction post-term with 25 micrograms vs. 50 micrograms of intravaginal misoprostol
International Journal of Gynaecology and Obstetrics, 2003
Objectives: To compare the effectiveness of 25 mg vs. 50 mg of intravaginal misoprostol for cervical ripening and labor induction beyond 41 weeks' gestation. Methods: The study population consisted of 120 women not in active labor with a gestational age )41 weeks, singleton pregnancy with vertex presentation, reactive fetal heart rate tracing, amniotic fluid index G5, and Bishop score -5. Women were randomized to receive either 25 mg (ns60) or 50 mg (ns60) of intravaginal misoprostol. The dose was repeated every 4 h (maximum number of doses limited to six) until the patient exhibited three contractions in 10 min. The main outcome measure was the induction-vaginal delivery interval. Results: There was no significant difference between the two groups with regard to the inductionvaginal delivery interval (685"201 min in the 25 mg group vs. 627"177 min in the 50 mg group, Ps0.09). The proportion of women delivering vaginally with one dose of vaginal misoprostol was significantly greater in the 50 mg group (0y49 vs. 41y47, P-0.001). There were no differences in the rates of cesarean and operative vaginal delivery rates, or in the incidences of tachysystole and hyperstimulation syndrome in the two treatment groups. Neonatal outcomes were also similar. Conclusions: Intravaginal administration of 25 mg of misoprostol appears to be as effective as 50 mg for cervical ripening and labor induction beyond 41 weeks' gestation.
Prediction of adverse outcome associated with vaginal misoprostol for labor induction
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2003
Objective: To identify predictors of adverse outcome in pregnant women at term receiving 50 mg of intravaginal misoprostol for labor induction. Study design: A prospective observational study was conducted of 720 pregnant women at term with an unfavorable cervix and a medical or obstetric indication for labor induction. All patients received 50 mg of intravaginal misoprostol every 4 h up to three doses. The primary outcome measure was ''adverse outcome'' defined as: neonatal death, fetal acidemia and emergent cesarean delivery performed for non-reassuring fetal heart rate tracings. A stepwise logistic regression analysis was used to identify predictors of adverse outcome. Results: Tachysystole (frequent uterine contractions) (odds ratio (OR), 3.7; 95% confidence interval (CI), 1.2-10.8) and fetal tachycardia (OR, 4.8; 95% CI, 1.4-16.2) were determined as significant predictors of adverse outcome. The specificity of the model was 94.2%, whereas the sensitivity was 20.4%. Conclusion: In the absence of tachysystole and fetal tachycardia, an uneventful delivery might be expected for women receiving 50 mg of intravaginal misoprostol.
2023
Objective: To compare the effectiveness and safety of 50μg of sublingual misoprostol administered six (6) hourly to that of 50μg of vaginal misoprostol administered four (4) hourly. Methodology: A non-blinded, randomized controlled trial conducted from Sept 1, 2014, to Nov 31, 2014, at a tertiary hospital in Ghana. Hundred and sixty women with medical or obstetric indications for labour induction were randomized into two groups. Results: The rate of vaginal delivery, caesarean section, uterine tachysystole and uterine hyperstimulation were similar in both groups. Sixty-three (78.8%) and 66 (82.5%) mothers in the vaginal and sublingual groups delivered vaginally. More (10.0%) mothers in the vagina group required emergency caesarean for foetal distress. Six (vaginal group) and 8 (sublingual group) of the mothers required emergency caesarean for cephalopelvic disproportion. Three mothers from each group had an emergency caesarean section due to failed labour induction. Almost the same number of mothers had uterine tachysystole in both groups. More (3.8%) mothers in the vaginal group had uterine hyperstimulation. Differences in the mean induction delivery interval and the need for oxytocin augmentation were not significant. No differences were found in the intrapartum passage of meconium, blood loss in the third stage of labour, 5-minute Apgar score <7, and neonatal intensive care unit admissions. Conclusion: The sublingual regimen was as effective and safe as the vaginal regimen in achieving vaginal delivery.
Comparison of Two Dosage Regimens of Vaginal Misoprostol for Induction of Labour at Term
2016
Objective: To compare the efficacy and safety of low and high dosage regimens of vaginal misoprostol for induction of labour at term. Design: A non-blinded randomized controlled trial. Setting: Labour room of Gynae unit I, Services Hospital/SIMS, Lahore. Participants: Two hundred pregnant women at term requiring induction of labour. Method: The women were randomized to receive 50μg (group A) and 100 μg (group B) of misoprostol vaginally every four hours to a maximum of five doses. Main outcome measures: Induction to delivery interval, need for oxytocin augmentation, mode of delivery, uterine hyperstimulation, failed induction and neonatal outcome. Results: The mean induction to delivery interval was significantly shorter in the 100μg group-high dosage (group B) with a mean difference of 7 hours and a p value <0.05. There was a significantly reduced need for oxytocin augmentation in the high dosage group B (4% vs 20%) and the incidence of failed induction was less in the high dosa...
Proceedings in Obstetrics and Gynecology, 2020
Introduction: The efficacy of misoprostol use for cervical priming before intrauterine device insertion (IUD) is controversial. This review aims to evaluate the evidence from published randomized controlled trials about the efficacy and safety of misoprostol before IUD insertion for pain relief in women with no previous vaginal delivery. Materials and methods: We searched the following electronic databases: Web of Science, Cochrane CENTRAL, SCOPUS, and PubMed for relevant studies using the following Mesh terms: (misoprostol) AND (intrauterine device OR IUD). The primary outcome was the mean pain score during insertion. Secondary outcomes included the ease of insertion score, the rate of successful IUD insertion, the rate of IUD insertion failure, and the adverse effects. Results: Ten randomized controlled trials (RCTs) (misoprostol: n=698 and placebo: n=689) were pooled in the analysis. The overall Standardized Mean Difference (SMD) of pain score did not favor either of the two groups (SMD=-0.09, 95%CI [-0.50, 0.33], p=0.007). Pooled results were highly heterogeneous (I2=93%, P<0.001). The total MD of the ease of insertion score favored the misoprostol group (MD=-1.36, 95% CI [-2.20,-0.52], p =0.002). The overall risk ratio (RR) of the number of failed insertions showed that misoprostol is associated with less IUD insertion failures compared to placebo (RR=0.55, 95% CI [0.38, 0.81], p=0.002). Finally, the overall risk showed that misoprostol is associated with more shivering, diarrhea and pelvic pain. Conclusions: Misoprostol facilitates IUD insertion in women with no previous vaginal delivery, and is associated with 50% less chance for IUD insertion failure despite inducing mild adverse effects brought to you by CORE View metadata, citation and similar papers at core.ac.uk provided by Iowa Research Online
Efficacy and safety of misoprostol for intrauterine device insertion in women with no previous vaginal delivery: a systematic review and meta-analysis of randomized controlled trials, 2020
Introduction: The efficacy of misoprostol use for cervical priming before intrauterine device insertion (IUD) is controversial. This review aims to evaluate the evidence from published randomized controlled trials about the efficacy and safety of misoprostol before IUD insertion for pain relief in women with no previous vaginal delivery. Materials and methods: We searched the following electronic databases: Web of Science, Cochrane CENTRAL, SCOPUS, and PubMed for relevant studies using the following Mesh terms: (misoprostol) AND (intrauterine device OR IUD). The primary outcome was the mean pain score during insertion. Secondary outcomes included the ease of insertion score, the rate of successful IUD insertion, the rate of IUD insertion failure, and the adverse effects. Results: Ten randomized controlled trials (RCTs) (misoprostol: n=698 and placebo: n=689) were pooled in the analysis. The overall Standardized Mean Difference (SMD) of pain score did not favor either of the two groups (SMD= -0.09, 95%CI [-0.50, 0.33], p=0.007). Pooled results were highly heterogeneous (I2=93%, P<0.001). The total MD of the ease of insertion score favored the misoprostol group (MD= -1.36, 95% CI [-2.20, -0.52], p =0.002). The overall risk ratio (RR) of the number of failed insertions showed that misoprostol is associated with less IUD insertion failures compared to placebo (RR=0.55, 95% CI [0.38, 0.81], p=0.002). Finally, the overall risk showed that misoprostol is associated with more shivering, diarrhea and pelvic pain. Conclusions: Misoprostol facilitates IUD insertion in women with no previous vaginal delivery, and is associated with 50% less chance for IUD insertion failure despite inducing mild adverse effects
BMC Pregnancy and Childbirth
Background: Oral misoprostol as an induction of labour (IOL) agent is rapidly gaining popularity in resource-limited settings because it is cheap, stable at ambient temperatures, and logistically easier to administer compared to dinoprostone and oxytocin. We aim to investigate the safety and effectiveness of a regimen of oral misoprostol in Papua New Guinean women undergoing IOL. Methods: As part of a prospective dose escalation study conducted at Modilon Hospital in Papua New Guinea, women with a singleton pregnancy in cephalic presentation and an unfavourable cervix who gave written informed consent were administered oral misoprostol, commencing at 25mcg once every 2 h for 4 doses and increased to 50mcg once every 2 h for 8 doses within 24 h. The primary outcomes studied were i) the proportion of women delivering within 24 h of oral misoprostol administration, and ii) rates of maternal and perinatal severe adverse events. Results: Of 6167 labour ward screened admissions, 209 women (3%) fulfilled the study inclusion criteria and underwent IOL. Overall, 74% (155/209 [95% confidence interval 67.6-79.9]) delivered within 24 h. Most women (90%; 188/209; 95% CI [84.9-93.5]) delivered vaginally with 86% (180/209) having a good outcome for both the mother and baby. Of the 10% (21/209) who failed IOL and underwent caesarean section, a significant proportion of their babies were admitted to special-care nursery compared to babies delivered vaginally (20/21 [95%] versus 8/ 188 [4%]; Fisher Exact test P < 0.001), but their perinatal mortality rate was not significantly higher (1/21 [5%] versus 2/188 [1%]; P = 0.30). The only maternal death was not study related and occurred in a patient with post-partum haemorrhage, 15 h post-delivery. Conclusion: The oral misoprostol regimen for IOL described in the present study is safe, effective and logistically feasible to administer in a resource-limited setting.