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New treatment option for Morbid Obesity
Official title Induction of Labor in Morbidly Obese Patients
ClinicalTrials.gov ID: NCT06199154
What this study is testing
What is Misoprostol?
Misoprostol is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for morbid obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.