Foley catheter plus oxytocin versus oxytocin alone for inducing labor after preterm PROM
Combination Oxytocin/Foley Versus Oxytocin Alone for Induction of Labor in Patients With Preterm Prelabor Rupture of Membranes
This trial tests whether adding a Foley catheter to oxytocin helps people with preterm PROM (34w0d–36w6d) go into labor and deliver faster than oxytocin alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Eastern Virginia Medical School Academic / other |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT07119398 on ClinicalTrials.gov |
What this trial studies
Patients with preterm prelabor rupture of membranes between 34 0/7 and 36 6/7 weeks, with a cervix ≤2 cm and a fetus in cephalic presentation, are enrolled at a single center. Enrolled participants receive either a Foley catheter plus oxytocin or oxytocin alone for induction and are monitored for labor progress, time to delivery, and maternal and neonatal outcomes. The trial excludes patients in spontaneous labor, with chorioamnionitis, significant cervical dilation, contraindications to a Foley, HIV, or known fetal anomalies. Study procedures and outcomes focus on whether the Foley plus oxytocin approach shortens the time to delivery and affects infection or other complications.
Who should consider this trial
Good fit: People aged 18–50 with PPROM between 34w0d and 36w6d, cervical dilation ≤2 cm, a cephalic fetus, and who can consent and receive care at the study site are ideal candidates.
Not a fit: Patients already in active labor, with cervical dilation >2 cm, chorioamnionitis, contraindications to a Foley, HIV, known fetal anomalies, or other exclusion criteria are unlikely to be eligible or benefit from this approach.
Why it matters
Potential benefit: If successful, adding a Foley catheter could shorten the time from induction to delivery and reduce the risks associated with prolonged membrane rupture.
How similar studies have performed: Previous randomized data show Foley plus oxytocin shortens time to delivery in term pregnancies and oxytocin versus misoprostol showed no clear difference in PPROM, but Foley use has not been prospectively tested in patients with PPROM.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Norfolk, Virginia
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Marwan Ma'ayeh, MD — Eastern Virginia Medical School
- Study coordinator: Kristin Ayers, MPH
- Email: ayerskl@evms.edu
- Phone: 7574460529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.