Induction of Labor in Morbidly Obese Patients

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06199154
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Morbid Obesity
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Misoprostol — DRUG
    Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.

Study Details

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.

Key Dates

Start date
Jul 15, 2024
Status verified
Jul 2025
Primary completion
May 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201
Rosa Drummond, MD
[email protected]
410-328-6436
Krista Mehlhaff, DO (PRINCIPAL_INVESTIGATOR)

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By research site
University of Maryland Medical Center· Baltimore, MD

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