NCT00346840

Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour

Controlled-Release Misoprostol Vaginal Insert in Parous Women for Labor Induction: Randomized Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.

Detailed description

Approximately 20% of pregnant women require medical intervention to induce labour for reasons including post-date pregnancy, pre-eclampsia, maternal diabetes, premature rupture of the membranes and intra-uterine fetal growth retardation. There are two fundamental changes that characterise pre-labour preparation for delivery: sensitisation of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. Prostaglandins (PG) are fundamental to both of these changes, and several forms have been used to successfully induce labour. Dinoprostone (PGE2) is an example of a cervical ripening agent that is available in gel and tablet form and has a proven record of successful cervical ripening in this population. Dinoprostone is also available in a controlled release vaginal delivery system, which is manufactured by Controlled Therapeutics (Scotland) a subsidiary of Cytokine PharmaSciences, Inc., King of Prussia, PA, USA. Another synthetic prostaglandin that has been shown to be an effective cervical ripener and labour inducer is misoprostol. Oral tablets are broken into fragments and used intravaginally to ripen the cervix and induce labour Due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labour induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Controlled Therapeutics has developed a controlled release vaginal delivery system similar to its marketed dinoprostone product but containing misoprostol. This study examines four dose strengths of the misoprostol vaginal insert in women who need to have their labours induced.

Conditions

• Labor Induction
• Cervical Ripening

Interventions

Type	Name	Description
DRUG	Misoprostol vaginal insert 25 mcg	One hydrogel polymer vaginal insert for up to 24h
DRUG	Misoprostol vaginal insert 50 mcg	One hydrogel polymer vaginal insert for up to 24h
DRUG	Misoprostol vaginal insert 100 mcg	One hydrogel polymer vaginal insert for up to 24h
DRUG	Misoprostol vaginal insert 200 mcg	One hydrogel polymer vaginal insert for up to 24h

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-02-01
• Completion: 2004-03-01
• First posted: 2006-06-30
• Last updated: 2012-06-18

Locations

6 sites across 1 country: United Kingdom