NCT01428037

Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

A Randomized,Double-blind,Placebo-controlled, Multicenter Study of the Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Regenex Pharmaceutical, China · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.

Detailed description

There are many pregnant women require medical intervention to induce labor for some reasons at term. There are two fundamental changes that characterize pre-labor preparation for delivery: sensitization of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of these changes. Low dose misoprostol is effective and safe for labor induction and has been used widely. Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex Corporation has developed a vaginal tablet with 25mcg misoprostol. The primary objective of the study was to assess of the efficacy and safety of low dose (25 mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour.

Conditions

• Cervical Ripening
• Induction of Labor

Interventions

Type	Name	Description
DRUG	Placebo	One tablet vaginal inserted at 4 hrly interval with maximum of three doses
DRUG	Misoprostol vaginal Tablet 25 mcg	One tablet vaginal insert at 4 hrly interval with maximum of three doses

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-09-02
• Last updated: 2013-11-25

Locations

6 sites across 1 country: China