Recruiting
Early Phase 1

Induction of Labor

Sponsor:

University of Maryland, Baltimore

Code:

NCT06199154

Conditions

Morbid Obesity

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Misoprostol

Study Details

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.

Conditions

Morbid Obesity

Pregnancy

Study ID

NCT06199154

Start date

Jul 15, 2024

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control - 25 mcg vaginal misoprostol

Participants will receive 25 mcg vaginal misoprostol every 4 hours.

experimental: Intervention - 50 mcg vaginal misoprostol

Participants will receive 50 mcg vaginal misoprostol every 4 hours.

Interventions

Misoprostol

Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.

Primary outcome measure

  • Achievement of complete cervical dilation [ Time Frame: Start of IOL until complete dilation ]

Central Contacts and Locations

Central contacts

Rosa Drummond, MD

4103285965rosa.drummond@umm.edu

Krista Mehlhaff, DO

4103285965KMehlhaff@som.umaryland.edu

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Rosa Drummond, MD

410-328-6436rosa.drummond@umm.edu

Principal Investigator:

Krista Mehlhaff, DO

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • induction of labor
  • morbid obesity
  • misoprostol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-29.