Inducing labor in morbidly obese patients using Misoprostol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial aims to compare the effectiveness of two different doses of Misoprostol (25 mcg vs 50 mcg) for inducing labor in morbidly obese patients with a BMI greater than 40. The study focuses on patients scheduled for induction of labor after 34 weeks of gestation, assessing their ability to achieve vaginal delivery and reduce the need for cesarean delivery. Participants will be randomly assigned to receive one of the two doses of Misoprostol every four hours, with the goal of improving delivery outcomes in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Rosa Drummond, MD
• Email: rosa.drummond@umm.edu
• Phone: 4103285965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.