Back to resultsCompare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA) (Misoprostol)
Primary Purpose
Misoprostol, Drug-induced Abortion
Status
Withdrawn
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Assess the efficacy and side effects of Misoprostol according to the route of administration
Sponsored by
About this trial
This is an interventional treatment trial for Misoprostol
Eligibility Criteria
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
Sites / Locations
- CHU Amiens Picardie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Administration of oral Misoprostol
Administration of Misoprostol vaginally
Administration of buccal Misoprostol
Arm Description
Outcomes
Primary Outcome Measures
Complete pregnancy evacuation on ultrasound at 3 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT03140384
First Posted
April 27, 2017
Last Updated
April 12, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03140384
Brief Title
Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
Acronym
Misoprostol
Official Title
Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
no regulatory approval
Study Start Date
August 20, 2017 (Anticipated)
Primary Completion Date
July 20, 2019 (Anticipated)
Study Completion Date
July 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Misoprostol, Drug-induced Abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Administration of oral Misoprostol
Arm Type
Active Comparator
Arm Title
Administration of Misoprostol vaginally
Arm Type
Active Comparator
Arm Title
Administration of buccal Misoprostol
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Assess the efficacy and side effects of Misoprostol according to the route of administration
Intervention Description
Assess the efficacy and side effects of Misoprostol according to the route of administration
Primary Outcome Measure Information:
Title
Complete pregnancy evacuation on ultrasound at 3 weeks
Time Frame
3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
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