Clinical trial NCT01279343: Cervical Foley Plus Vaginal Misoprostol for Labor Induction
Official title: Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Keywords: labor induction
foley bulb
misoprostol
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 123
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* vertex presentation
* unfavorable cervix(Bishop's score less than or equal to 6)
* greater than 24 weeks gestation

Exclusion Criteria:

* fetal malpresentation
* multifetal gestation
* spontaneous labor
* more than 5 uterine contractions in 10 minutes
* contraindication to prostaglandins
* non-reassuring fetal heart rate tracing
* intrauterine growth restriction
* anomalous fetus
* fetal demise
* previous cesarean delivery or other significant uterine surgery

Primary outcomes:
measure: Time From Start of Labor Induction to Vaginal Delivery
timeFrame: 72 hours
Secondary outcomes:
measure: Successful Number of Vaginal and Cesarean Deliveries
timeFrame: 72 hours
measure: Number of Participants Experiencing Tachysystole With Deceleration
timeFrame: 72 hours
measure: Number of Participants With Post-partum Hemorrhage
timeFrame: 96 hours
measure: Chorioamnionitis
timeFrame: 96 hours
measure: Neonatal APGAR Scores
timeFrame: 5 minutes
measure: NICU Admission
timeFrame: 96 hours
measure: Time to Complete Cervical Dilation
timeFrame: 72 hours
measure: Delivery Within 24 Hours
timeFrame: Delivery within 24 hours of induction
measure: Admission to NICU or Special Care Nursery
timeFrame: birth to 96 hours of age
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jeanine F Carbone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.