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NCT Number: NCT07119398

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

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.

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Key information

Conditions

Preterm PROM (Pregnancy) Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Pregnancy Complications Preterm Premature Rupture of the Membranes Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location status: Recruiting

Location contact

Marwan Ma'ayeh, MD

CONTACT

[email protected]

757-446-7900

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin plus Foley Catheter

Combination Product

Intravenous oxytocin and a transcervical Foley catheter

Oxytocin

Drug

Intravenous oxytocin

Primary outcomes

  1. Vaginal Delivery within 12 Hours

    Time frame: 12 hours

    Vaginal Delivery within 12 hours of induction

Secondary outcomes

  1. Vaginal Delivery Rate

    Time frame: From enrollment until delivery

    Overall vaginal delivery rate

  2. Intraamniotic Infection

    Time frame: Enrollment through 6 weeks postpartum

  3. Operative vaginal delivery

    Time frame: From enrollment until delivery

  4. Cesarean delivery

    Time frame: From enrollment until delivery

  5. Estimated and quantitative blood loss

    Time frame: From enrollment until hospital discharge (up to 5 days post-delivery).

  6. Blood transfusion

    Time frame: From enrollment until hospital discharge (up to 5 days post-delivery)

  7. Maternal morbidity and adverse maternal outcomes

    Time frame: From enrollment until 6 weeks postpartum

    Including endometritis / chorioamnionitis, wound infection, venous thromboembolism, massive transfusion and postpartum hemorrhage, ICU admission, and maternal death

  8. Antepartum, intrapartum, or neonatal death

    Time frame: From enrollment until 6 weeks postpartum

  9. Suspected and confirmed neonatal sepsis

    Time frame: From delivery until hospital discharge (up to 5 days post-delivery)

  10. Birth weight

    Time frame: Recorded day of delivery

  11. Hypoglycemia (glucose &amp;lt; 35 mg/dl) requiring IV glucose therapy

    Time frame: From birth until hospital discharge (up to 5 days post-delivery)

  12. Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours

    Time frame: From birth until 72 hours after delivery

  13. Neonatal encephalopathy

    Time frame: From birth until hospital discharge (up to 5 days after delivery)

    As defined by the NICHD Neonatal Research Network criteria

  14. Seizures

    Time frame: From birth until hospital discharge (up to 5 days post-delivery)

  15. Shoulder dystocia

    Time frame: Recorded day of delivery

  16. Birth trauma

    Time frame: Recorded day of delivery

    Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy

  17. Intracranial hemorrhage

    Time frame: From birth until hospital discharge (up to 5 days post-delivery)

    Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma

  18. Hyperbilirubinemia requiring phototherapy or exchange transfusion

    Time frame: From birth until hospital discharge (up to 5 days post-delivery)

  19. NICU admission

    Time frame: From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Ayers, MPH

CONTACT

[email protected]

7574460529

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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