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

NCT07119398 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Preterm PROM (Pregnancy)

Interventions

COMBINATION_PRODUCT

Oxytocin plus Foley Catheter

Intravenous oxytocin and a transcervical Foley catheter

DRUG

Oxytocin

Intravenous oxytocin

Sponsors & Collaborators

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Marwan Ma'ayeh, MD · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2026-07-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119398 on ClinicalTrials.gov