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

NCT03140384 | Withdrawn Phase 3

• 1 other identifier: PI2016_843_0033
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Misoprostol; Drug-induced Abortion

Outcome Measures

Primary Outcomes (1)

• Complete pregnancy evacuation on ultrasound at 3 weeks

  3 weeks

Study Arms (3)

Administration of oral Misoprostol

ACTIVE COMPARATOR

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

Administration of Misoprostol vaginally

ACTIVE COMPARATOR

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

Administration of buccal Misoprostol

ACTIVE COMPARATOR

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

Interventions

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

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

Administration of Misoprostol vaginally; Administration of buccal Misoprostol; Administration of oral Misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \> 18 years hospitalized using abortions between 7 and 9 SA and after informed consent,
• Affiliation to a social security scheme.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 4, 2017
• Study Start: August 20, 2017
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

FR (1)