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
Eastern Virginia Medical School
80 participants
Jul 14, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Intravenous oxytocin and a transcervical Foley catheter
Intravenous oxytocin
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07119398