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NCT Number: NCT06259097

Different Medications to Induce Labor

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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Key information

Conditions

Pregnancy Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mount Sinai Hospital, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

25 mcg vaginally every 6 hours

Other names: Miso

Pitocin

Drug

3-6 mL intravenously every hour

Primary outcomes

  1. Time from induction to delivery

    Time frame: start of induction until delivery

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

Secondary outcomes

  1. Delivery outcome

    Time frame: at delivery

    Simple determination whether patient had a vaginal delivery or delivered by cesarean section.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Perelman, MD

CONTACT

[email protected]

Nicola F Tavella, MPH

CONTACT

[email protected]

2122413888

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Bronx Care Health System

Registry information

Official study title

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

Acronym: BLOOM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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