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

Eastern Virginia Medical School (EVMS)

Status and phase: Enrolling; Phase 4

Conditions: Preterm PROM (Pregnancy)

Treatments: Drug: Oxytocin; Combination Product: Oxytocin plus Foley Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT07119398

24-04-FB-0086

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Oxytocin plus Foley

Experimental group

Description:

• Induction of labor with intravenous oxytocin and a transcervical Foley catheter

Treatment:

Combination Product: Oxytocin plus Foley Catheter

Oxytocin Only

Active Comparator group

Description:

• Induction of labor with intravenous oxytocin

Treatment:

Drug: Oxytocin