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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.
Barnes Jewish Hospital
St Louis, Missouri, United States
Time From Start of Labor Induction to Vaginal Delivery
Time frame: 72 hours
Successful Number of Vaginal and Cesarean Deliveries
To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.
Time frame: 72 hours
Number of Participants Experiencing Tachysystole With Deceleration
Time frame: 72 hours
Number of Participants With Post-partum Hemorrhage
Time frame: 96 hours
Chorioamnionitis
Time frame: 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)
Time frame: 5 minutes
NICU Admission
Time frame: 96 hours
Time to Complete Cervical Dilation
We will record the start time of induction until the patient's cervix is 10cm dilated
Time frame: 72 hours
Delivery Within 24 Hours
Time frame: Delivery within 24 hours of induction
Admission to NICU or Special Care Nursery
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Time frame: birth to 96 hours of age