RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combination Oxytocin/Foley Versus Oxytocin Alone for Induction of Labor in Patients With Preterm Prelabor Rupture of Membranes

Quick Facts

Study Start:2025-07-14
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07119398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 18-50 years of age;
  2. * The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
  3. * PPROM;
  4. * Cervical dilation \</= 2cm
  5. * Fetal cephalic presentation;
  6. * 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.
  1. * Spontaneous labor
  2. * Known allergy to latex;
  3. * Cervical dilation \>2cm;
  4. * Chorioamnionitis;
  5. * Contraindications to induction of labor or use of Foley for cervical ripening
  6. * HIV
  7. * Known or suspected fetal anomaly or aneuploidy;
  8. * Prisoners.

Contacts and Locations

Study Contact

Kristin Ayers, MPH
CONTACT
7574460529
ayerskl@evms.edu

Principal Investigator

Marwan Ma'ayeh, MD
PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School

Study Locations (Sites)

Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Eastern Virginia Medical School

  • Marwan Ma'ayeh, MD, PRINCIPAL_INVESTIGATOR, Eastern Virginia Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • Induction
  • PPROM
  • Preterm prelabor rupture of membranes

Additional Relevant MeSH Terms

  • Preterm PROM (Pregnancy)