Different Medications to Induce Labor

NCT ID: NCT06259097

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Misoprostol and Pitocin

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

25 mcg vaginally every 6 hours

Pitocin

Intervention Type DRUG

3-6 mL intravenously every hour

Pitocin only

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

Group Type ACTIVE_COMPARATOR

Pitocin

Intervention Type DRUG

3-6 mL intravenously every hour

Interventions

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Misoprostol

25 mcg vaginally every 6 hours

Intervention Type DRUG

Pitocin

3-6 mL intravenously every hour

Intervention Type DRUG

Other Intervention Names

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Miso

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bronx Care Health System

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Angela Bianco

Division Director, MFM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola F Tavella, MPH

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Angela Bianco, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Bronx Care Health System

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicola F Tavella, MPH

Role: CONTACT

2122413888

Allison Perelman, MD

Role: CONTACT

Facility Contacts

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Nicola F Tavella, MPH

Role: primary

212-241-3888

Emmanuel Afful, MD, MPH

Role: primary

718-239-8389

Other Identifiers

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STUDY-24-00118

Identifier Type: -

Identifier Source: org_study_id

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