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

April 12, 2018 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Administration of oral Misoprostol
Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration
Assess the efficacy and side effects of Misoprostol according to the route of administration
ACTIVE_COMPARATOR: Administration of Misoprostol vaginally
Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration
Assess the efficacy and side effects of Misoprostol according to the route of administration
ACTIVE_COMPARATOR: Administration of buccal Misoprostol
Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration
Assess the efficacy and side effects of Misoprostol according to the route of administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete pregnancy evacuation on ultrasound at 3 weeks
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 20, 2017

Primary Completion (ANTICIPATED)

July 20, 2019

Study Completion (ANTICIPATED)

July 20, 2019

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2016_843_0033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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