Different Medications to Induce Labor

NCT06259097 — Phase 3, Completed, 303 participants, Icahn School of Medicine at Mount Sinai

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

Registry	NCT06259097, acronym BLOOM
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	303 (Actual)
Sponsor	Icahn School of Medicine at Mount Sinai (Other); collaborators: Bronx Care Health System
Conditions	Pregnancy, Labor
Interventions	Misoprostol, Pitocin (Drug)
Dates	start 2024-07-02, primary completion 2026-08-10, completion 2026-08-10, first posted 2024-02-14, last updated 2026-08-18
Locations	2 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Misoprostol and Pitocin	Active comparator	Drug: Misoprostol; Drug: Pitocin	Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.
Pitocin only	Active comparator	Drug: Pitocin	Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.

Misoprostol (Drug), also known as Miso: 25 mcg vaginally every 6 hours
Pitocin (Drug): 3-6 mL intravenously every hour

+Outcome measures

Primary outcomes

Time from induction to delivery [start of induction until delivery]: Simple measure calculating time from start of induction until delivery of neonate.

Secondary outcomes

Delivery outcome [at delivery]: Simple determination whether patient had a vaginal delivery or delivered by cesarean section.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
Mount Sinai Hospital	New York, New York	United States
Bronx Care Health System	The Bronx, New York	United States

+Study documents

Informed Consent Form (PDF, 2026-03-03)

+Investigators

Nicola F Tavella, MPH, Study director, Icahn School of Medicine at Mount Sinai
Angela Bianco, MD, Principal investigator, Icahn School of Medicine at Mount Sinai