NCT07119398

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Oxytocin plus Foley Catheter	Intravenous oxytocin and a transcervical Foley catheter
DRUG	Oxytocin	Intravenous oxytocin

Timeline

• Start date: 2025-07-14
• Primary completion: 2026-07-30
• Completion: 2026-12-30
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study