Induction of Labor in Morbidly Obese Patients (NCT06199154) | Clinical Trial Compass
RecruitingEarly Phase 1
Induction of Labor in Morbidly Obese Patients
United States162 participantsStarted 2024-07-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.