Cervical Foley Plus Vaginal Misoprostol for Labor Induction

Not Applicable

Completed

• Conditions: Induction of Labor
• Interventions: Device: Foley bulb

• Registration Number: NCT01279343
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-19
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2019-04-09
• Results First Submitted QC: 2019-04-09
• Status Verified: 2019-05
• Results First Posted: 2019-05-01
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley Bulb plus Misoprostol	Foley bulb	-

Primary Outcome Measures

Name	Time	Method
Time From Start of Labor Induction to Vaginal Delivery	72 hours

Secondary Outcome Measures

Name	Time	Method
Successful Number of Vaginal and Cesarean Deliveries	72 hours	To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.
Chorioamnionitis	96 hours
NICU Admission	96 hours
Time to Complete Cervical Dilation	72 hours	We will record the start time of induction until the patient's cervix is 10cm dilated
Number of Participants Experiencing Tachysystole With Deceleration	72 hours
Number of Participants With Post-partum Hemorrhage	96 hours
Neonatal APGAR Scores	5 minutes	APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)
Delivery Within 24 Hours	Delivery within 24 hours of induction
Admission to NICU or Special Care Nursery	birth to 96 hours of age

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States