NCT06199154 Induction of Labor in Morbidly Obese Patients
| NCT ID | NCT06199154 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Morbid Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 162 participants in total. It began in 2024-07-15 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06199154 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Morbid Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06199154 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06199154 currently recruiting?
Yes, NCT06199154 is actively recruiting participants. Contact the research team at rosa.drummond@umm.edu for enrollment information.
Where is the NCT06199154 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06199154 clinical trial?
NCT06199154 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 162 participants.
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