Trials / Completed
CompletedNCT01973036
FOLCROM Trial: Foley Catheter in Rupture of Membranes
Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 201 (actual)
- Sponsor
- Geisinger Clinic · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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.
Detailed description
This is a prospective, randomized, multi-center clinical trial to test the hypothesis that in women with term and near term premature rupture of membranes (PROM), an intrauterine Foley catheter plus oxytocin infusion will decrease the mean time from induction to delivery by 2.5 hours as compared to oxytocin alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-07-01
- Completion
- 2016-08-01
- First posted
- 2013-10-31
- Last updated
- 2018-09-24
- Results posted
- 2018-09-24
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01973036. Inclusion in this directory is not an endorsement.