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

Centre Hospitalier Universitaire, Amiens

Status and phase: Withdrawn; Phase 3

Conditions: Misoprostol; Drug-induced Abortion

Treatments: Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03140384

PI2016_843_0033

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Administration of oral Misoprostol

Active Comparator group

Treatment:

Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration

Administration of Misoprostol vaginally

Active Comparator group

Treatment:

Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration

Administration of buccal Misoprostol

Active Comparator group

Treatment:

Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration