Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Eastern Virginia Medical School
Study ID
NCT07119398
Phase
PHASE4
Status
Recruiting
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Conditions

  • Preterm PROM (Pregnancy)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxytocin plus Foley Catheter — COMBINATION_PRODUCT
    Intravenous oxytocin and a transcervical Foley catheter
  • Oxytocin — DRUG
    Intravenous oxytocin

Study Details

Data on the optimal mode of labor induction after preterm prelabor rupture of membranes (PPROM) is lacking. Studies have shown no difference between oxytocin and misoprostol use for labor induction in this cohort (1). The preponderance of evidence from term pregnancies suggests that Foley catheter coupled with oxytocin is better than oxytocin alone, with a higher rate of delivery within 24 hours when a Foley catheter followed by oxytocin is compared to oxytocin alone. However, the use of a Foley catheter has not been evaluated in prospective studies on patients with PPROM.

Key Dates

Start date
Jul 14, 2025
Status verified
Aug 2025
Primary completion
Jul 30, 2026
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: Oxytocin plus Foley
    • Induction of labor with intravenous oxytocin and a transcervical Foley catheter
  • Active Comparator: Oxytocin Only
    • Induction of labor with intravenous oxytocin

Primary Outcome Measure

Vaginal Delivery within 12 Hours [ Time Frame: 12 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sentara Norfolk General HospitalNorfolkVirginia23507
Marwan Ma'ayeh, MD
[email protected]
757-446-7900

Find similar trials in Norfolk, VA

By research site
Sentara Norfolk General Hospital· Norfolk, VA

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