Status:
RECRUITING
Induction of Labor in Morbidly Obese Patients
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Morbid Obesity
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI \>40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients re...
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
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06199154
Start Date
July 15 2024
End Date
October 1 2026
Last Update
July 3 2025
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201