Induction of Labor in Morbidly Obese Patients
Recruiting · NCT06199154 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Misoprostol
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Maryland Medical Center - Baltimore, Maryland, United States