Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

Phase 2

Completed

• Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
• Interventions: Drug: Misoprostol

• Registration Number: NCT02680314
• Lead Sponsor: Montefiore Medical Center

Brief Summary

The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances of having a successful vaginal delivery as compared to using more than one dose of misoprostol, followed by treatment with oxytocin.

Detailed Description

This study involves a comparison of two different regimens of prostaglandin use for "cervical ripening" prior to induction of labor. Women admitted to the hospital for induction of labor who are found to have "unripe" cervixes at the time of admission, and who agree to participate in the study will be randomly assigned to one of two treatment groups. In one group, a single dose of 25 µcg of misoprostol will be administered vaginally and four hours later oxytocin induction will be started if clinically indicated. In the second group of women, repeat doses of misoprostol will be given every four hours up to six doses unless labor or cervical ripening occurs sooner. At this point, oxytocin will be started as needed. Success of vaginal delivery by 24 hours, time from initiation of protocol to delivery and cesarean section rates will be compared. Complications such as postpartum hemorrhage, episodes of tachysystole with fetal compromise and chorioamnionitis and endometritis will be monitored.

Study Timeline

• Study First Submitted: 2016-01-22
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-11
• Primary Completion: 2017-05-17
• Study Completion: 2021-06-16
• Results First Submitted: 2021-06-16
• Results First Submitted QC: 2021-07-08
• Results First Posted: 2021-07-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 243

Inclusion Criteria

• Any pregnant woman undergoing induction of labor
• Live singleton pregnancy ≥ 37 week gestation
• Bishop score < 6
• Category I fetal heart rate

Exclusion Criteria

• Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)
• Pregnancies complicated by major fetal anomalies
• Any contraindication to the use of misoprostol, including
• History of previous c-section or major uterine surgery
• Prior allergic reaction
• Category II or III fetal heart rate
• Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes
• Estimated fetal weight < 10 percentile
• Premature rupture of membranes
• Age < 18 years old
• Women who do not have the capacity to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Dose	Misoprostol	multiple doses of misoprostol
Single Dose	Misoprostol	single dose of misoprostol

Primary Outcome Measures

Name	Time	Method
Number of Participants With Vaginal Delivery Within 24 Hours	within 24 hours	To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication.

Secondary Outcome Measures

Name	Time	Method
To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group	within 24 hours from the initial intervention	To determine the interval from initiation of misoprostol to delivery in each group