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FOLCROM Trial: Foley Catheter in Rupture of Membranes

NCT01973036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2018-09-24

Study results available
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Summary

Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.

Conditions

  • Premature Rupture of Membranes

Interventions

DEVICE

Foley Catheter

The balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.

DRUG

Oxytocin

Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.

Sponsors & Collaborators

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Awathif D Mackeen, MD, MPH · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973036 on ClinicalTrials.gov