Clinical trial

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

Name

STUDY-24-00118

Description

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.

Trial arms

Trial start

2024-07-01

Estimated PCD

2026-04-01

Trial end

2026-04-01

Status

Recruiting

Phase

Early phase I

Treatment

Misoprostol

25 mcg vaginally every 6 hours

Arms:

Misoprostol and Pitocin

Other names:

Miso

Pitocin

3-6 mL intravenously every hour

Arms:

Misoprostol and Pitocin, Pitocin only

Size

300

Primary endpoint

Time from induction to delivery

start of induction until delivery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

Updated at

2024-05-24

1 organization

2 products

2 indications

Organization

Icahn School of Medicine at Mount Sinai

Product

Indication

Indication

Product