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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-20

Study Completion Date

2019-07-20

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.

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Detailed Description

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Conditions

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Misoprostol Drug-induced Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of oral Misoprostol

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

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

Administration of Misoprostol vaginally

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

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

Administration of buccal Misoprostol

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

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

Interventions

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

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No