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NCT06259097 Clinical Trial

Different Medications to Induce Labor

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06259097
Other study ID # STUDY-24-00118
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 2024
Est. completion date April 2026

Study information
Verified date February 2024
Source Icahn School of Medicine at Mount Sinai
Contact Nicola F Tavella, MPH
Phone 2122413888
Email nicola.tavella@mssm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol and Pitocin
25 mcg vaginally every 6 hours (miso) and 3-6 mL intravenously every hour (pitocin)
• Pitocin only
3-6 mL intravenously every hour (pitocin)

Locations
Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time from induction to delivery Simple measure calculating time from start of induction until delivery of neonate. start of induction until delivery
Secondary Delivery outcome Simple determination whether patient had a vaginal delivery or delivered by cesarean section. at delivery
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