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

NCT07119398 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-04-FB-0086
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Keywords

Induction; PPROM; Preterm prelabor rupture of membranes

Outcome Measures

Primary Outcomes (1)

• Vaginal Delivery within 12 Hours

  Vaginal Delivery within 12 hours of induction

  12 hours

Secondary Outcomes (19)

• Vaginal Delivery Rate

  From enrollment until delivery

• 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).

Study Arms (2)

Oxytocin plus Foley

EXPERIMENTAL

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

Combination Product: Oxytocin plus Foley Catheter

Oxytocin Only

ACTIVE COMPARATOR

• Induction of labor with intravenous oxytocin

Drug: Oxytocin

Interventions

Oxytocin plus Foley Catheter COMBINATION_PRODUCT

Intravenous oxytocin and a transcervical Foley catheter

Oxytocin plus Foley

Oxytocin DRUG

Intravenous oxytocin

Oxytocin Only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 26244535 BACKGROUND

• 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.

  PMID: 37793430 BACKGROUND

• 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.

  PMID: 28479288 BACKGROUND

• 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.

  PMID: 29215519 BACKGROUND

• 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.

  PMID: 27824758 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 16135593 BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Preterm Premature Rupture of the Membranes

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marwan Ma'ayeh, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Ayers, MPH

CONTACT

7574460529; ayerskl@evms.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a non-blinded prospective randomized pilot trial of pregnant patients with a singleton pregnancy between 34 weeks 0 days and 36 weeks 6 days gestation with PPROM receiving an induction of labor. Participants will be randomized to either: * Induction of labor with intravenous oxytocin * Induction of labor with intravenous oxytocin and a transcervical Foley catheter

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 13, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)