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NCT03140384: Misoprostol

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

Withdrawn Phase 3 Last updated 17 April 2018
What this trial tests

Phase 3 trial testing Assess the efficacy and side effects of Misoprostol according to the route of administration in Misoprostol. Withdrawn.

Timeline
20 August 2017
Primary endpoint
20 July 2019
20 July 2019

Quick facts

Lead sponsorCentre Hospitalier Universitaire, Amiens
PhasePhase 3
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Start date20 August 2017
Primary completion20 July 2019
Estimated completion20 July 2019
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, female only, with Misoprostol or Drug-induced Abortion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Medical methods for first trimester abortion.
    Zhang J, Zhou K, Shan D, Luo X. · · 2022 · cited 19× · PMID 35608608 · DOI 10.1002/14651858.cd002855.pub5

Verify or expand the search:

Other recruiting trials for Misoprostol

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire, Amiens trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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