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

NCT ID: NCT07119398

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2026-12-30

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.

Conditions

Preterm PROM (Pregnancy)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxytocin plus Foley

• Induction of labor with intravenous oxytocin and a transcervical Foley catheter

Group Type: EXPERIMENTAL

Oxytocin plus Foley Catheter

Intervention Type: COMBINATION_PRODUCT

Intravenous oxytocin and a transcervical Foley catheter

Oxytocin Only

• Induction of labor with intravenous oxytocin

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Intravenous oxytocin

Interventions

Oxytocin plus Foley Catheter

Intravenous oxytocin and a transcervical Foley catheter

Intervention Type: COMBINATION_PRODUCT

Oxytocin

Intravenous oxytocin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: lead

Responsible Party

Marwan Ma'ayeh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwan Ma'ayeh, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristin Ayers, MPH

Role: CONTACT

ayerskl@evms.edu

7574460529

Facility Contacts

Marwan Ma'ayeh, MD

Role: primary

maayehmg@odu.edu

757-446-7900

References

McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.

Reference Type: BACKGROUND

PMID: 26244535 (View on PubMed)

Gomez Slagle HB, Hoffman MK, Sciscione AC, Ma'ayeh M. Combination Foley Catheter-Oxytocin versus Oxytocin Alone following Preterm Premature Rupture of Membranes. Am J Perinatol. 2024 May;41(S 01):e3030-e3034. doi: 10.1055/a-2185-4102. Epub 2023 Oct 4.

Reference Type: BACKGROUND

PMID: 37793430 (View on PubMed)

Amorosa JMH, Stone J, Factor SH, Booker W, Newland M, Bianco A. A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP). Am J Obstet Gynecol. 2017 Sep;217(3):360.e1-360.e7. doi: 10.1016/j.ajog.2017.04.038. Epub 2017 May 4.

Reference Type: BACKGROUND

PMID: 28479288 (View on PubMed)

Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.

Reference Type: BACKGROUND

PMID: 29215519 (View on PubMed)

Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.

Reference Type: BACKGROUND

PMID: 27824758 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28486381 (View on PubMed)

Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57.

Reference Type: BACKGROUND

PMID: 16135593 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

24-04-FB-0086

Identifier Type: -

Identifier Source: org_study_id