Different Medications to Induce Labor

Phase 3

Recruiting

• Conditions: Pregnancy; Labor
• Interventions: Drug: Pitocin; Drug: Misoprostol

• Registration Number: NCT06259097
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

This is a randomized controlled trial examining whether the use of misoprostol or pitocin, in combination with a foley catheter, is more effective at inducing labor in patients with a gravid BMI that is considered obese.

Detailed Description

This randomized controlled trial will include patients with a BMI greater than 30 at the time of admission for their induction of labor. Patients will be randomized to either misoprostol or Pitocin to begin induction of labor, alongside the standard foley catheter, and the primary outcome of interest will be length of time from start of induction until delivery.

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-14
• Study Start: 2024-07-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Pregnant patient presenting to labor & delivery for induction of labor with a BMI > = 30

Exclusion Criteria

• Pregnant patient presenting to labor & delivery for induction of labor with BMI < 30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitocin only	Pitocin	Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.
Misoprostol and Pitocin	Misoprostol	Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.
Misoprostol and Pitocin	Pitocin	Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.

Primary Outcome Measures

Name	Time	Method
Time from induction to delivery	start of induction until delivery	Simple measure calculating time from start of induction until delivery of neonate.

Secondary Outcome Measures

Name	Time	Method
Delivery outcome	at delivery	Simple determination whether patient had a vaginal delivery or delivered by cesarean section.

Trial Locations

Locations (2)

Bronx Care Health System; 🇺🇸 Bronx, New York, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States