NCT06199154RecruitingEarly phase 1
Induction of Labor in Morbidly Obese Patients
Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 4 Dec 2023
- Start date
- Jul 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Obesity
- NCT number
- NCT06199154
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 162
- From Jul 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
Other illness
- History of cesarean delivery
- Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
- Contraindications to labor (cardiac, neurosurgical, need for cesarean)
- Significant vaginal bleeding with concern for placental abruption
- Non-reassuring fetal status or fetal heart rate decelerations
Age
- Age \< 18yo
Other
- Fetal growth restriction with abnormal umbilical artery Doppler indices
- Cervical dilation \>5 cm
- Contractions \>5 per 10 minutes
- Fetal demise or major fetal anomaly
- Inability to give consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.