Clinical trial
Induction of Labor in Morbidly Obese Patients
Recruiting now · Early Phase 1 · 1 countries · Registry ID NCT06199154
Recruiting nowEarly Phase 1Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionMorbid Obesity, Pregnancy
Full registry criteria
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
Treatments and study arms
Misoprostol
Drug
Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.
Primary outcomes
Achievement of complete cervical dilationStart of IOL until complete dilation
Study locations
1 locations were listed when this page was built. The first 40 are shown.
University of Maryland Medical Center🇺🇸 Baltimore, Maryland, United States
Rosa Drummond, MDContact
Krista Mehlhaff, DOPrincipal Investigator