Actively Recruiting
Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM
Led by Eastern Virginia Medical School · Updated on 2025-08-13
80
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 to 50 years of age
- Able to understand and willing to participate in the study
- Diagnosed with preterm prelabor rupture of membranes (PPROM)
- Cervical dilation of 2 centimeters or less
- Baby is in fetal cephalic presentation (head-down position)
- Gestational age between 34 weeks 0 days and 36 weeks 6 days at enrollment, confirmed by last menstrual period and first trimester ultrasound
You will not qualify if you...
- Experiencing spontaneous labor
- Known allergy to latex
- Cervical dilation greater than 2 centimeters
- Presence of chorioamnionitis (infection of the fetal membranes)
- Any contraindications to labor induction or use of a Foley catheter for cervical ripening
- HIV infection
- Known or suspected fetal anomaly or aneuploidy
- Prisoner status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
K
Kristin Ayers, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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