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

Study Overview
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Brief Summary
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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.

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

Conditions
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Misoprostol, Drug-induced Abortion

Intervention / Treatment
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* Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Administration of oral Misoprostol<br> | Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration<br>* Assess the efficacy and side effects of Misoprostol according to the route of administration<br>|
| Active Comparator: Administration of Misoprostol vaginally<br> | Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration<br>* Assess the efficacy and side effects of Misoprostol according to the route of administration<br>|
| Active Comparator: Administration of buccal Misoprostol<br> | Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration<br>* Assess the efficacy and side effects of Misoprostol according to the route of administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pregnancy evacuation on ultrasound at 3 weeks |  | 3 weeks |