Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Rosa Drummond, MD
rosa.drummond@umm.edu
4103285965
Backup
Krista Mehlhaff, DO
KMehlhaff@som.umaryland.edu
4103285965
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2026-10
Participants
Target number of participants: 162
Treatments
Active_comparator: Control - 25 mcg vaginal misoprostol
Participants will receive 25 mcg vaginal misoprostol every 4 hours.
Experimental: Intervention - 50 mcg vaginal misoprostol
Participants will receive 50 mcg vaginal misoprostol every 4 hours.
Related Therapeutic Areas
Sponsors
Leads: University of Maryland, Baltimore