CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 201 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01973036
NCT01973036N/ACompleted
CompareCT.gov

Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)

Geisinger Clinic·interventional·Posted Oct 31, 2013·Updated Sep 24, 2018

In Brief

A clinical study evaluating Foley Catheter and Oxytocin for Premature Rupture of Membranes. Completed, enrolled 201 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Rupture of Membranes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 31, 2013
Enrollment StartMar 1, 2014
Primary CompletionJul 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.7 years ago

Interventions

Foley Catheterdevice

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.

Oxytocindrug

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.