Foley catheter plus oxytocin versus oxytocin alone for inducing labor after preterm PROM

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Selective antibiotics when symptoms develop versus universal antibiotics for preterm neonates

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.