CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 491 enrolled
Drug / intervention
Misoprostol Alone +3 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/NCT01916681
NCT01916681N/ACompleted

Foley OR MisO for the Management of Induction (FOR MOMI) Trial

University of Pennsylvania·interventional·Posted Aug 6, 2013·Updated May 18, 2017

In Brief

A clinical study evaluating Cervical Foley & Misoprostol, Misoprostol Alone, and 2 other interventions for Delivery; Prolonged. Completed, enrolled 491 participants across 1 site.

Detailed Summary

The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2013
Enrollment StartMay 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.9 years ago

Interventions

Cervical Foley & Misoprostoldevice

A cervical foley combined with misoprostol will be used to induce the patient.

Misoprostol Alonedrug

Misoprostol will be used alone to induce the patient

Cervical Foley Alonedevice

A cervical foley alone will be used to induce the patient

Cervical Foley & Pitocindevice

A cervical foley combined with pitocin will be used to induce the patient