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

Phase 3

Withdrawn

• Conditions: Misoprostol; Drug-induced Abortion
• Interventions: Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration

• Registration Number: NCT03140384
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Study Start: 2017-08-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17
• Primary Completion: 2019-07-20
• Study Completion: 2019-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women > 18 years hospitalized using abortions between 7 and 9 SA and after informed consent,
• Affiliation to a social security scheme.

Exclusion Criteria

• Minor or major women under guardianship or curatorship
• BMI <18.5 (thinness)
• Ambulatory
• Several abortions on the duration of the study
• Take Mifepristone> 48 hours before taking Misoprostol
• Contraindications to Misoprostol: Prostaglandin Allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of buccal Misoprostol	Assess the efficacy and side effects of Misoprostol according to the route of administration	-
Administration of oral Misoprostol	Assess the efficacy and side effects of Misoprostol according to the route of administration	-
Administration of Misoprostol vaginally	Assess the efficacy and side effects of Misoprostol according to the route of administration	-

Primary Outcome Measures

Name	Time	Method
Complete pregnancy evacuation on ultrasound at 3 weeks	3 weeks

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France