Induction of Labor in Morbidly Obese Patients

This study is looking at different doses of a medication called Misoprostol to help start labor (induction of labor) in pregnant people who have morbid obesity (a Body Mass Index or BMI of 40 or higher). The goal is to see if one dose of Misoprostol (25 mcg or 50 mcg, given vaginally every 4 hours) works better to help achieve a vaginal delivery. This is important because morbid obesity can make it harder to have a vaginal delivery, sometimes leading to a C-section. Researchers hope to find a way to improve vaginal delivery rates and reduce surgical risks for these patients. The study plans to enroll 162 participants and is currently recruiting. You may be able to join if you are 18 or older, speak English or Spanish, are between 34 and 42 weeks pregnant with a single baby, and have a BMI of 40 or higher.

Study design
This is a randomized, controlled, double-blind study comparing two different doses of Misoprostol. It plans to enroll 162 participants.
What's involved
Participants will receive either 25 mcg or 50 mcg of vaginal Misoprostol every 4 hours. The study measures the time from the start of labor induction until complete cervical dilation.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06199154

Induction of Labor in Morbidly Obese Patients

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~162 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Misoprostol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Achievement of complete cervical dilation
Measured over Start of IOL until complete dilation
Morbid Obesity
Pregnancy
1 sites across 1 states
Maryland1

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Eligibility criteria

Inclusion

Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
Speaks English or Spanish
Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
Age 18 years old or older
Viable, single, cephalic fetus
Intent to proceed with cervical ripening - cervical exam: dilation \< 5 cm
Contractions \< 5 per 10 minutes

Exclusion

History of cesarean delivery
Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
Contraindications to labor (cardiac, neurosurgical, need for cesarean)
Age \< 18yo
Fetal growth restriction with abnormal umbilical artery Doppler indices
Cervical dilation \>5 cm
Contractions \>5 per 10 minutes
Significant vaginal bleeding with concern for placental abruption
Non-reassuring fetal status or fetal heart rate decelerations
Fetal demise or major fetal anomaly
Inability to give consent
  • Achievement of complete cervical dilationStart of IOL until complete dilation