Different Medications to Induce Labor

NCT06259097 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY-24-00118
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy; Labor

Outcome Measures

Primary Outcomes (1)

• Time from induction to delivery

  Simple measure calculating time from start of induction until delivery of neonate.

  start of induction until delivery

Secondary Outcomes (1)

• Delivery outcome

  at delivery

Study Arms (2)

Misoprostol and Pitocin

ACTIVE COMPARATOR

Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.

Drug: Misoprostol; Drug: Pitocin

Pitocin only

ACTIVE COMPARATOR

Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.

Drug: Pitocin

Interventions

Misoprostol DRUG

25 mcg vaginally every 6 hours

Also known as: Miso

Misoprostol and Pitocin

Pitocin DRUG

3-6 mL intravenously every hour

Misoprostol and Pitocin; Pitocin only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Bronx Care Health System: collaborator

Study Sites (2)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Bronx Care Health System

The Bronx, New York, 10457, United States

RECRUITING

MeSH Terms

Interventions

Misoprostol; Soy Foods; Oxytocin

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Fermented Foods; Diet, Food, and Nutrition; Physiological Phenomena; Vegetable Products; Vegetables; Food; Food and Beverages; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nicola F Tavella, MPH

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Angela Bianco, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola F Tavella, MPH

CONTACT

2122413888; nicola.tavella@mssm.edu

Allison Perelman, MD

CONTACT

allison.perelman@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director, MFM

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 14, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to Nicola.tavella@mssm.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)