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

• Oxytocin plus Foley Catheter (Combination product): Intravenous oxytocin and a transcervical Foley catheter
• Oxytocin (Drug): Intravenous oxytocin

Primary outcomes

• Vaginal Delivery within 12 Hours [12 hours]: Vaginal Delivery within 12 hours of induction

Secondary outcomes

• Vaginal Delivery Rate [From enrollment until delivery]: Overall vaginal delivery rate
• Intraamniotic Infection [Enrollment through 6 weeks postpartum]
• Operative vaginal delivery [From enrollment until delivery]
• Cesarean delivery [From enrollment until delivery]
• Estimated and quantitative blood loss [From enrollment until hospital discharge (up to 5 days post-delivery).]
• Blood transfusion [From enrollment until hospital discharge (up to 5 days post-delivery)]
• Maternal morbidity and adverse maternal outcomes [From enrollment until 6 weeks postpartum]: Including endometritis / chorioamnionitis, wound infection, venous thromboembolism, massive transfusion and postpartum hemorrhage, ICU admission, and maternal death
• Antepartum, intrapartum, or neonatal death [From enrollment until 6 weeks postpartum]
• Suspected and confirmed neonatal sepsis [From delivery until hospital discharge (up to 5 days post-delivery)]
• Birth weight [Recorded day of delivery]
• Hypoglycemia (glucose < 35 mg/dl) requiring IV glucose therapy [From birth until hospital discharge (up to 5 days post-delivery)]
• Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours [From birth until 72 hours after delivery]
• Neonatal encephalopathy [From birth until hospital discharge (up to 5 days after delivery)]: As defined by the NICHD Neonatal Research Network criteria
• Seizures [From birth until hospital discharge (up to 5 days post-delivery)]
• Shoulder dystocia [Recorded day of delivery]
• Birth trauma [Recorded day of delivery]: Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
• Intracranial hemorrhage [From birth until hospital discharge (up to 5 days post-delivery)]: Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
• Hyperbilirubinemia requiring phototherapy or exchange transfusion [From birth until hospital discharge (up to 5 days post-delivery)]
• NICU admission [From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first]

Sex: Female, ages: 18 Years to 50 Years

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.

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• Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032. PMID 28486381
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• Study Protocol and Statistical Analysis Plan (PDF, 2025-07-02)
• Informed Consent Form (PDF, 2025-07-02)

• Marwan Ma'ayeh, MD, Principal investigator, Eastern Virginia Medical School