Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Not Applicable

Completed

• Conditions: Induction of Labor
• Interventions: Drug: Misoprostol; Drug: Oxytocin

• Registration Number: NCT01139801
• Lead Sponsor: Aultman Health Foundation

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Results First Submitted: 2018-01-29
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-22
• Last Update Submitted: 2018-08-22
• Results First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Oxytocin	Oxytocin	Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.

Primary Outcome Measures

Name	Time	Method
Rate of Induction To Delivery	24 hrs	To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times

Secondary Outcome Measures

Name	Time	Method
Delivery Route	24 hrs	To assess for differences in delivery routes

Trial Locations

Locations (1)

Aultman Health Foundation; 🇺🇸 Canton, Ohio, United States