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

Misoprostol Clinical Trial

— Misoprostol  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03140384
• Other study ID #: PI2016_843_0033
• Status: Withdrawn
• Phase: Phase 3
• First received: April 27, 2017
• Last updated: April 12, 2018
• Start date: August 20, 2017
• Est. completion date: July 20, 2019

Study information

• Verified date: April 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amenorrhea
• Drug-induced Abortion
• Misoprostol

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pregnancy evacuation on ultrasound at 3 weeks		3 weeks