Cervical Foley Plus Vaginal Misoprostol for Labor Induction
Recruitment status was Recruiting
The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial|
- Time from start of labor induction to vaginal delivery [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Successful number of vaginal deliveries [ Time Frame: 72 hours ] [ Designated as safety issue: No ]To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.
- tachysystole requiring terbutaline use [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
- Post-partum hemorrhage [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
- Chorioamnionitis [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
- neonatal APGAR scores [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]APGAR scores will be recorded at 1, 5 and 10 minutes after birth.
- NICU admission [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
- Time to complete cervical dilation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]We will record the start time of induction until the patient's cervix is 10cm dilated
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|No Intervention: Foley Bulb plus Misoprostol||
Device: Foley bulb
This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.
Other Name: cytotec
|No Intervention: Misoprostol|
More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279343
|Contact: Jeanine F Carbone, MDfirstname.lastname@example.org|
|Contact: Patricia Fogertey, RN, MSNemail@example.com|
|United States, Missouri|
|Barnes Jewish Hospital||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jeanine F Carbone, MD||Washington University Early Recognition Center|