NCT01933360

Misoprostol for Cervical Priming Prior to Vacuum Aspiration

Sublingual Versus Vaginal Misoprostol for Cervical Dilatation 1 or 3 Hours Prior to Surgical Abortion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.

Conditions

• First Trimester Pregnancy
• Surgical Termination of Pregnancy

Interventions

Type	Name	Description
DRUG	Misoprostol sublingual, 1h	Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
DRUG	Placebo sublingual,1h	Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
DRUG	Misoprostol sublingual, 3h	Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy
DRUG	Misoprostol vaginal, 1h	Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
DRUG	Misoprostol vaginal, 3h	Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy
DRUG	Placebo sublingual, 3h	Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy
DRUG	Placebo vaginal, 1h	Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
DRUG	Placebo vaginal, 3h	Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-09-02
• Last updated: 2014-08-15

Locations

1 site across 1 country: Sweden