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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Withdrawn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
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

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WITHDRAWN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
Primary Outcome Measures
NameTimeMethod
Complete pregnancy evacuation on ultrasound at 3 weeks3 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CHU Amiens Picardie

🇫🇷

Amiens, Picardie, France

CHU Amiens Picardie
🇫🇷Amiens, Picardie, France

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