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

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03140384
Acronym
Misoprostol
Enrollment
0
Registered
2017-05-04
Start date
2017-08-20
Completion date
2019-07-20
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-induced Abortion, Misoprostol

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.

Interventions

BIOLOGICALAssess 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Complete pregnancy evacuation on ultrasound at 3 weeks3 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026