Different Medications to Induce Labor (BLOOM)

Misoprostol Versus Pitocin for Induction of Labor in Patients With BMI > 30: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Labor
• Intervention / Treatment: Drug: Misoprostol; Drug: Pitocin

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nicola F Tavella, MPH; Phone Number: 2122413888; Email: nicola.tavella@mssm.edu
• Study Contact Backup: Name: Allison Perelman, MD; Email: allison.perelman@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Nicola F Tavella, MPH; Phone Number: 2122413888; Email: nicola.tavella@mssm.edu
      • Principal Investigator: Angela T Bianco
    • The Bronx, New York, United States, 10457
      • Recruiting
      • Bronx Care Health System
      • Principal Investigator: Gary Markoff, MD
      • Contact: Emmanuel Afful, MD, MPH; Phone Number: (718) 239-8389; Email: eafful1@bronxcare.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol and Pitocin; Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.	Drug: Misoprostol; 25 mcg vaginally every 6 hours; Other Names: Miso; Drug: Pitocin; 3-6 mL intravenously every hour
Active Comparator: Pitocin only; Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.	Drug: Pitocin; 3-6 mL intravenously every hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from induction to delivery	Simple measure calculating time from start of induction until delivery of neonate.	start of induction until delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery outcome	Simple determination whether patient had a vaginal delivery or delivered by cesarean section.	at delivery

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Bronx Care Health System
• Investigators: Principal Investigator: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai; Study Director: Nicola F Tavella, MPH, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Fatty Acids; Lipids; Biological Factors; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fermented Foods; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Pituitary Hormones, Posterior; Pituitary Hormones; Prostaglandins E, Synthetic; Vegetable Products; Vegetables; Oxytocin; Misoprostol; Soy Foods
• Other Study ID Numbers: STUDY-24-00118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No