NCT01139801

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Aultman Health Foundation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Induction of Labor

Interventions

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

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-06-09
• Last updated: 2018-08-24
• Results posted: 2018-08-24

Locations

1 site across 1 country: United States