Recruiting

Foley Catheter & Oxytocin

Sponsor:

Eastern Virginia Medical School

Code:

NCT07119398

Conditions

Preterm PROM (Pregnancy)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Oxytocin plus Foley Catheter

Oxytocin

Study Details

Brief 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)

Study ID

NCT07119398

Start date

Jul 14, 2025

Status verified date

Aug, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients 18-50 years of age;
  • The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
  • PPROM;
  • Cervical dilation </= 2cm
  • Fetal cephalic presentation;
  • The patient is between 34 weeks 0 days and 36 weeks 6 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.

Exclusion Criteria:

  • Spontaneous labor
  • Known allergy to latex;
  • Cervical dilation >2cm;
  • Chorioamnionitis;
  • Contraindications to induction of labor or use of Foley for cervical ripening
  • HIV
  • Known or suspected fetal anomaly or aneuploidy;
  • Prisoners.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Oxytocin plus Foley Catheter

Intravenous oxytocin and a transcervical Foley catheter

Oxytocin

Intravenous oxytocin

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kristin Ayers, MPH

7574460529ayerskl@evms.edu

Locations

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Marwan Ma'ayeh, MD

757-446-7900maayehmg@odu.edu

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Keywords

  • Induction
  • PPROM
  • Preterm prelabor rupture of membranes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2025-08-13.