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

Combination Oxytocin/Foley Versus Oxytocin Alone for Induction of Labor in Patients With Preterm Prelabor Rupture of Membranes

Who can join

Ages 18 to 50 · Women

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.

About the study

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.

What is being tested

• Oxytocin plus Foley Catheter (combination product)
• Oxytocin (drug)

Sponsor: Eastern Virginia Medical School · Participants: 80 · Started: Jul 14, 2025

Contact the study team

• Kristin Ayers, MPH · Phone: 7574460529

Official record on ClinicalTrials.gov — NCT07119398

Locations in the U.S.

Conditions

• Preterm Premature Rupture of the Membranes

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.