Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
NCT06199154

Induction of Labor in Morbidly Obese Patients

Led by University of Maryland, Baltimore · Updated on 2025-07-03

162

Participants Needed

1

Research Sites

115 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Induction of Labor in Morbidly Obese Patients

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Morbidly obese (BMI 240 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 with cervical dilation less than 5 cm
  • Contractions fewer than 5 per 10 minutes
Not Eligible

You will not qualify if you...

  • History of cesarean delivery
  • Contraindication to prostaglandin administration (including significant myomectomy or prior cesarean delivery)
  • Contraindication to vaginal delivery (such as placenta previa, vasa previa, or high viral load HIV)
  • Contraindications to labor (including cardiac or neurosurgical conditions or need for cesarean)
  • Age under 18 years
  • Fetal growth restriction with abnormal umbilical artery Doppler indices
  • Cervical dilation greater than 5 cm
  • Contractions more than 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

R

Rosa Drummond, MD

CONTACT

K

Krista Mehlhaff, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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