Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
Overview
- Phase
- Not Applicable
- Intervention
- Oxytocin
- Conditions
- Induction of Labor
- Sponsor
- Aultman Health Foundation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of Induction To Delivery
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.
Detailed Description
The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant or surrogate is capable of giving informed consent
- •Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
- •Participant is undergoing an indicated induction of labor
- •Participant is found to have cervical Bishop score ≤5 on initial cervical exam
- •Participant has no medical or obstetrical contraindications to induction of labor
Exclusion Criteria
- •Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
- •Manufacturer's contraindications to misoprostol or oxytocin
Arms & Interventions
Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
Intervention: Oxytocin
Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Intervention: Misoprostol
Outcomes
Primary Outcomes
Rate of Induction To Delivery
Time Frame: 24 hrs
To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times
Secondary Outcomes
- Delivery Route(24 hrs)