Comparing medications to induce labor in obese pregnant patients
Misoprostol Versus Pitocin for Induction of Labor in Patients With BMI > 30: A Randomized Controlled Trial
This study is testing whether misoprostol or Pitocin works better to help obese pregnant women start labor and deliver their babies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06259097 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effectiveness of misoprostol versus Pitocin, combined with a foley catheter, for inducing labor in pregnant patients with a BMI greater than 30. Participants will be randomly assigned to receive either medication upon admission for labor induction. The primary outcome measured will be the duration from the start of induction to delivery, providing insights into which medication may be more effective for this population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals with a BMI of 30 or greater who are presenting for labor induction.
Not a fit: Patients with a BMI less than 30 will not benefit from this study as they do not meet the inclusion criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved labor induction methods for obese pregnant patients, potentially reducing delivery times and associated complications.
How similar studies have performed: Other studies have explored labor induction methods, but this specific comparison in obese patients is less common, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 1 other locations
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
- Bronx Care Health System — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Angela Bianco, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Nicola F Tavella, MPH
- Email: nicola.tavella@mssm.edu
- Phone: 2122413888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.