Inducing labor in morbidly obese patients using Misoprostol
Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial
This study is testing whether two different doses of Misoprostol can help morbidly obese women have a vaginal delivery instead of a cesarean section when inducing labor.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06199154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are morbidly obese pregnant women (BMI ≥ 40) who are at least 18 years old and scheduled for induction of labor after 34 weeks of gestation.
Not a fit: Patients with a history of cesarean delivery or contraindications to vaginal delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rates of vaginal delivery and reduced surgical complications for morbidly obese patients during labor.
How similar studies have performed: While there is limited research specifically on Misoprostol dosing in morbidly obese patients, similar studies have shown that optimizing labor induction methods can improve delivery outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Rosa Drummond, MD
- Email: rosa.drummond@umm.edu
- Phone: 4103285965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.