NCT03140384

Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.

Conditions

• Misoprostol
• Drug-induced Abortion

Interventions

Type	Name	Description
BIOLOGICAL	Assess the efficacy and side effects of Misoprostol according to the route of administration	Assess the efficacy and side effects of Misoprostol according to the route of administration

Timeline

• Start date: 2017-08-20
• Primary completion: 2019-07-20
• Completion: 2019-07-20
• First posted: 2017-05-04
• Last updated: 2018-04-17

Locations

1 site across 1 country: France