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

Not Applicable

Recruiting

• Conditions: Preterm PROM (Pregnancy)
• Interventions: Combination Product: Oxytocin plus Foley Catheter; Drug: Oxytocin

• Registration Number: NCT07119398
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-14
• Study First Submitted: 2025-07-21
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-07-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin plus Foley	Oxytocin plus Foley Catheter	• Induction of labor with intravenous oxytocin and a transcervical Foley catheter
Oxytocin Only	Oxytocin	• Induction of labor with intravenous oxytocin

Primary Outcome Measures

Name	Time	Method
Vaginal Delivery within 12 Hours	12 hours	Vaginal Delivery within 12 hours of induction

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States