Dataset Information

A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial.

ABSTRACT: BACKGROUND:Cervical ripening is commonly needed for labor induction. Finding an optimal route of misoprostol dosing for efficacy, safety, and patient satisfaction is important and not well studied for the buccal route. OBJECTIVE:To compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at term. STUDY DESIGN:The IMPROVE trial was an institutional review board-approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ?6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) and a matching placebo tablet by the opposite route. The primary outcomes were time to delivery and the rate of cesarean delivery performed urgently for fetal nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. RESULTS:The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, Pnoninferiority = .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3% for the vaginal misoprostol group and 9.5% for the buccal misoprostol group (P = .033). The rate of vaginal delivery in <24 hours was higher in the vaginal group (58.6% vs 39.2%, P = .001). CONCLUSION:We were unable to demonstrate noninferiority. In leading to a higher rate of vaginal deliveries, more rapid vaginal delivery, and fewer cesareans for fetal issues, vaginal misoprostol may be superior to buccal misoprostol for cervical ripening at term.

SUBMITTER: Haas DM

PROVIDER: S-EPMC7692024 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial.

Haas David M DM Daggy Joanne J Flannery Kathleen M KM Dorr Meredith L ML Bonsack Carrie C Bhamidipalli Surya S SS Pierson Rebecca C RC Lathrop Anthony A Towns Rachel R Ngo Nicole N Head Annette A Morgan Sarah S Quinney Sara K SK

American journal of obstetrics and gynecology 20190507 3

<h4>Background</h4>Cervical ripening is commonly needed for labor induction. Finding an optimal route of misoprostol dosing for efficacy, safety, and patient satisfaction is important and not well studied for the buccal route.<h4>Objective</h4>To compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at term.<h4>Study design</h4>The IMPROVE trial was an institutional review board-approved, triple-masked, placebo-controlled randomized noninferiority ...[more]

PMID: 31075246

Similar Datasets

Project description:BackgroundThe safest, most effective and fastest combined approaches to induction of labor is unknown. In an open-label randomized clinical trial we evaluated the efficacy of combination of extra-amniotic Foley's catheter and vaginal misoprostol compared to vaginal misoprostol alone for cervical ripening and induction of labor on the incidence of failed induction, induction-to-delivery interval and adverse maternal and perinatal outcomes.MethodsPregnant women at gestational age of 28 weeks or greater admitted at Kenyatta National Hospital, Kenya for induction of labor were enrolled then randomized to either a combination of extra-amniotic Foley's catheter inflated by 30 cm3 of normal saline and 25 micrograms of vaginal misoprostol or 25 micrograms of vaginal misoprostol alone. Women underwent 6 hourly reviews and additional misoprostol inserted if required. The primary outcome was incidence of failed induction. Secondary outcomes were induction-to-delivery interval and adverse maternal and perinatal outcomes. We conducted an intent-to-treat analysis and compared means or medians using t-test or Wilcoxon rank, proportions using Chi-square or Fishers test as appropriate. Induction-to-delivery interval were compared using the log-rank test. P-values of < 0.05 and 95% confidence intervals that excluded the null were considered statistically significant.ResultsBetween February and May 2016, we enrolled 180 of 237 pregnant women admitted for induction of labor and randomized them to either a combination of extra-amniotic Foley's catheter and vaginal misoprostol (n = 90) or vaginal misoprostol alone (n = 90). The socio-demographic and obstetric characteristics were similar between the two groups. Failed induction rates were lower but not statistically significant following combined extra-amniotic Foley's catheter and vaginal misoprostol (8.9%) versus vaginal misoprostol alone (11.1%). The mean induction-to-delivery time was 4.8 h shorter in the combined extra-amniotic Foley's catheter and vaginal misoprostol (mean 18.9, standard deviation (SD) 7.2 h) compared to misoprostol only group (mean 14.1, SD 6.9 h) (log-rank test, p < 0.001). Maternal and perinatal complications were similar between the two groups.ConclusionsExtra-amniotic Foley's catheter and vaginal misoprostol for cervical ripening and induction of labor did not significantly lower the incidence of failed induction but safely shortened induction-to-delivery time compared to vaginal misoprostol only.Trial registrationTrial was retrospectively registered on 14-03-2016 PACTR201604001535825.

Project description:ObjectiveTo evaluate whether cervical ripening with oral misoprostol increases cesarean delivery risk and prolongs time to vaginal delivery compared with vaginal misoprostol in a predominantly overweight population.MethodsThis single center, retrospective cohort study was performed at a tertiary care academic medical center and compared labor induction outcomes with vaginal misoprostol to outcomes with oral misoprostol after a complete institutional shift to oral misoprostol. Labor induction using 25 micrograms vaginal misoprostol in 2013-2014 was compared with 50 micrograms oral misoprostol in 2014-2015. The primary outcome was cesarean delivery. Secondary outcomes included time to vaginal delivery, uterine tachysystole, maternal hemorrhage, and composite adverse neonatal outcomes. Demographics and outcomes were analyzed using standard statistical tests. Multivariable regression models accounting for potential confounders were created for the primary and secondary outcomes with adjusted odds ratios (aOR) as the measures of effect.ResultsThere were 138 women in the oral and 138 women in the vaginal misoprostol groups. In the overall cohort, the median (interquartile range) body mass index was 31.7 (28.2-36.8) and most women (72%) were of either black or Hispanic race or ethnicity. The frequency of cesarean delivery was higher in the oral than the vaginal misoprostol group (32% vs 21%; P=.04). The adjusted odds of cesarean was higher with oral misoprostol (aOR 2.01; 95% CI 1.07-3.76). Among nulliparous women, the frequency of cesarean delivery was 41% in the oral and 28% in the vaginal misoprostol groups (aOR 2.79; 95% CI 1.26-6.19). Women had a longer time to vaginal delivery in the oral compared with vaginal misoprostol group (41 vs 31 hours respectively, P=.01). Tachysystole occurred more frequently with vaginal misoprostol (20% vs 11%; P=.04).ConclusionCompared with vaginal misoprostol, oral misoprostol may be associated with increased risk of cesarean delivery and longer time to vaginal delivery.

Project description:ObjectiveTo compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women before operative hysteroscopy.DesignTwo separate but identical parallel, randomised, double-blind, placebo-controlled sequential trials, one in premenopausal women and one in postmenopausal women. The boundaries for the sequential trials were calculated on the primary outcomes of a difference of cervical dilatation > or = 1 mm, with the assumption of a type 1 error of 0.05 and a power of 0.95.SettingNorwegian university teaching hospital.SampleEighty-six women referred to outpatient operative hysteroscopy.MethodsThe women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient operative hysteroscopy.Main outcome measuresPreoperative cervical dilatation (primary outcome), number of women who achieve a preoperative cervical dilatation > or = 5 mm, acceptability, complications and adverse effects (secondary outcomes).ResultsIn premenopausal women, the mean cervical dilatation was 6.4 mm (SD 2.4) in the misoprostol group and 4.8 mm (SD 2.0) in the placebo group, the mean difference in cervical dilatation being 1.6 mm (95% CI 0.5-2.7). Among the premenopausal women receiving misoprostol, 88% achieved a cervical dilatation of > or = 5 mm compared with 65% in the placebo group. Twelve percent of the women who received misoprostol were difficult to dilate compared with 32% who received placebo. Dilatation was also quicker in the misoprostol group. Misoprostol had no effect on cervical ripening in postmenopausal women compared with placebo, and 43% of the women were difficult to dilate. The trials were terminated after analysis of 21 postmenopausal women and 65 premenopausal women after reaching a conclusion on the primary outcome with only 28% of the number of women needed in a fixed sample size trial. Three of 45 women who received misoprostol experienced severe lower abdominal pain, and there was an increased occurrence of light preoperative bleeding in the misoprostol group. Most women did not experience misoprostol-related adverse effects. The majority (83% of premenopausal and 76% of postmenopausal women) found self-administered vaginal misoprostol at home to be acceptable. There were two serious complications in the premenopausal misoprostol group: uterine perforation with subsequent peritonitis and heavy postoperative bleeding requiring blood transfusion, but these were not judged to be misoprostol related. Complications were otherwise comparatively minor and distributed equally between the two dosage groups.ConclusionsOne thousand micrograms of self-administered vaginal misoprostol 12 hours prior to operative hysteroscopy has a significant cervical ripening effect compared with placebo in premenopausal but not in postmenopausal women. Self-administered vaginal misoprostol of 1000 micrograms at home the evening before operative hysteroscopy is safe and highly acceptable, although a small proportion of women experienced severe lower abdominal pain. There is a risk of lower abdominal pain and light preoperative bleeding with this regimen, which is very cheap and easy to use.

Project description:Objective This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals.Study design This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5 cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (L&D) stay. Multivariable analysis was used to adjust for patient characteristics.Results Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR] = 1.21, 95% confidence interval [CI]: 0.96-1.52), Foley (21.3%, aRR = 1.16, 95% CI: 0.92-1.45), or Foley-oxytocin (19.4%, aRR = 1.04, 95% CI: 0.83-1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR = 0.35, 95% CI: 0.16-0.75) or Foley (3.6%, aRR = 0.51, 95% CI: 0.29-0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR = 0.63, 95% CI: 0.40-1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter L&D stay (adjusted mean difference = -1.97 hours, 95% CI: -3.45 to -0.49 and -5.92 hours, 95% CI: -7.07 to -4.77, respectively), compared with PGE.Conclusion In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of L&D stay was the shortest with concurrent Foley-oxytocin.Key points· Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.. · Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.. · The use of Foley alone, or in combination with other agents, appears to be beneficial..

Project description:Currently, there is no meta-analysis comparing intravaginal misoprostol plus intracervical Foley catheter versus intravaginal misoprostol alone for term pregnancy without identifying risk factors. Therefore, the purpose of this study is to conduct a systematic review and meta-analysis of randomized control trials (RCTs) comparing concurrent intravaginal misoprostol and intracervical Foley catheter versus intravaginal misoprostol alone for cervical ripening. We systematically searched Embase, Pubmed, and Cochrane Collaboration databases for randomized controlled trials (RCTs) comparing intracervical Foley catheter plus intravaginal misoprostol and intravaginal misoprostol alone using the search terms "Foley", "misoprostol", "cervical ripening", and "induction" up to 29 January 2019. Data were extracted and analyzed by two independent reviewers including study characteristics, induction time, cesarean section (C/S), clinical suspicion of chorioamnionitis, uterine tachysystole, meconium stain, and neonatal intensive care unit (NICU) admissions. Data was pooled using random effects modeling and calculated with risk ratio (RR) and 95% confidence interval (CI). Pooled analysis from eight studies, including 1110 women, showed that labor induction using a combination of intracervical Foley catheter and intravaginal misoprostol decreased induction time by 2.71 h (95% CI -4.33 to -1.08, p = 0.001), as well as the risk of uterine tachysystole and meconium staining (RR 0.54, 95% CI 0.30-0.99 and RR 0.48, 95% CI 0.32-0.73, respectively) significantly compared to those using intravaginal misoprostol alone. However, there was no difference in C/S rate (RR 0.93, 95% CI 0.78-1.11) or clinical suspicion of chorioamnionitis rate (RR 1.22, CI 0.58-2.57) between the two groups. Labor induction with a combination of intracervical Foley catheter and intravaginal misoprostol may be a better choice based on advantages in shortening induction time and reducing the risk of uterine tachysystole and meconium staining compared to intravaginal misoprostol alone.

Dataset Information

A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial.

Publications

A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets