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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)
Phase 3 trial testing Assess the efficacy and side effects of Misoprostol according to the route of administration in Misoprostol. Withdrawn.
20 July 2019
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 20 August 2017 |
| Primary completion | 20 July 2019 |
| Estimated completion | 20 July 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- Assess the efficacy and side effects of Misoprostol according to the route of administration — full drug profile →
Conditions studied
- Misoprostol — all drugs for Misoprostol →
- Drug-induced Abortion — all drugs for Drug-induced Abortion →
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):
-
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:
- PubMed search for NCT03140384
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Misoprostol
Currently open trials in the same condition.
- NCT06946914 — Misoprostol Before Caesarean Section · Phase 4 · recruiting
Other Centre Hospitalier Universitaire, Amiens trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03140384 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens
- Last refreshed: 17 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03140384.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing