Cervical Foley Plus Vaginal Misoprostol for Labor Induction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial

Conditions
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Induction of Labor

Intervention / Treatment
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* Device: Foley bulb


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foley Bulb plus Misoprostol<br> | Device: Foley bulb<br>* This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.<br>* Other names: cytotec;|
| No Intervention: Misoprostol<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Start of Labor Induction to Vaginal Delivery |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Number of Vaginal and Cesarean Deliveries | To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries. | 72 hours | 
| Number of Participants Experiencing Tachysystole With Deceleration |  | 72 hours | 
| Number of Participants With Post-partum Hemorrhage |  | 96 hours | 
| Chorioamnionitis |  | 96 hours | 
| Neonatal APGAR Scores | 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) | 5 minutes | 
| NICU Admission |  | 96 hours | 
| Time to Complete Cervical Dilation | We will record the start time of induction until the patient's cervix is 10cm dilated | 72 hours | 
| Delivery Within 24 Hours |  | Delivery within 24 hours of induction | 
| Admission to NICU or Special Care Nursery |  | birth to 96 hours of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor induction, foley bulb, misoprostol