NCT07119398PHASE4Recruiting
Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM
Eastern Virginia Medical School
Start Date
7/14/2025
Completion Date
12/30/2026
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.
Eligibility Criteria
Age Range: 18 years to 50 years
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.
Interventions
COMBINATION_PRODUCT
Oxytocin plus Foley Catheter
DRUG
Oxytocin
Conditions
Preterm PROM (Pregnancy)
Locations
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States