Cervical Foley Plus Vaginal Misoprostol for Labor Induction
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About
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.
Full 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.
Enrollment
Sex
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
123 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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