No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
162 (estimated)
Sponsor
University of Maryland, Baltimore · Other
Who this trial is looking for
This trial is looking for morbidly obese pregnant women to participate in a study that tests two different doses of a medication called Misoprostol for inducing labor. If you join, you will receive one of the doses to see how it helps with vaginal delivery.
Are You a Good Fit for This Trial?
Rules you outSignificant myomectomyPlacenta previaVasa previaHIV with high viral loadCardiac conditionNeurosurgical conditionNeed for cesareanFetal demise
You may be able to join if
I have a BMI of 40 or higher.
I speak English or Spanish.
I am between 34 weeks and 42 weeks pregnant.
I am 18 years old or older.
I have a single baby in the head-down position.
I plan to have cervical ripening.
My cervix is not more than 5 cm dilated.
I have no more than 5 contractions in 10 minutes.
You may not be able to join if
I have had a cesarean delivery before.
I have a condition that prevents me from using prostaglandins.
I have a condition that prevents me from having a vaginal delivery.
I have a condition that prevents me from going into labor.
I am younger than 18 years old.
My baby has growth restrictions with abnormal test results.
My cervix is more than 5 cm dilated.
I have more than 5 contractions in 10 minutes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Status
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 - cervi…
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
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