Actively Recruiting

Phase 4
Age: 18Years - 50Years
FEMALE
NCT07119398

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

Led by Eastern Virginia Medical School · Updated on 2025-08-13

80

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 to 50 years of age
  • Able to understand and willing to participate in the study
  • Diagnosed with preterm prelabor rupture of membranes (PPROM)
  • Cervical dilation of 2 centimeters or less
  • Baby is in fetal cephalic presentation (head-down position)
  • Gestational age between 34 weeks 0 days and 36 weeks 6 days at enrollment, confirmed by last menstrual period and first trimester ultrasound
Not Eligible

You will not qualify if you...

  • Experiencing spontaneous labor
  • Known allergy to latex
  • Cervical dilation greater than 2 centimeters
  • Presence of chorioamnionitis (infection of the fetal membranes)
  • Any contraindications to labor induction or use of a Foley catheter for cervical ripening
  • HIV infection
  • Known or suspected fetal anomaly or aneuploidy
  • Prisoner status

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Actively Recruiting

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Research Team

K

Kristin Ayers, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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