Different Medications to Induce Labor

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06259097
Phase
PHASE3
Status
Recruiting

Conditions

  • Labor
  • Pregnancy

Eligibility Criteria

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

Interventions

  • Misoprostol — DRUG
    25 mcg vaginally every 6 hours
  • Pitocin — DRUG
    3-6 mL intravenously every hour

Study Details

This is a randomized controlled trial examining whether the use of misoprostol or pitocin, in combination with a foley catheter, is more effective at inducing labor in patients with a gravid BMI that is considered obese.

Key Dates

Start date
Jul 2, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

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

Arms

  • Active Comparator: Misoprostol and Pitocin
    Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.
  • Active Comparator: Pitocin only
    Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.

Primary Outcome Measure

Time from induction to delivery [ Time Frame: start of induction until delivery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Nicola F Tavella, MPH
2122413888
Angela T Bianco (PRINCIPAL_INVESTIGATOR)
Bronx Care Health SystemThe BronxNew York10457
Emmanuel Afful, MD, MPH
(718) 239-8389
Gary Markoff, MD (PRINCIPAL_INVESTIGATOR)

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