Phase 2 N=243 Randomized Treatment

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

Labor; Forced or Induced, Affecting Fetus or Newborn

Bottom Line

View on ClinicalTrials.gov: NCT02680314 ↗

Enrolled (actual)

243

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Number of Participants With Vaginal Delivery Within 24 Hours — 50; 55 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Misoprostol (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Montefiore Medical Center
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Vaginal Delivery Within 24 Hours	50; 55	—
SECONDARY To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group	1187; 1321	0.202

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02680314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.