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

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ClinicalTrials.gov Identifier: NCT03140384
Recruitment Status : Withdrawn (no regulatory approval)
First Posted : May 4, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Misoprostol Drug-induced Abortion Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
Estimated Study Start Date : August 20, 2017
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Active Comparator: Administration of oral Misoprostol 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

Active Comparator: Administration of Misoprostol vaginally 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

Active Comparator: Administration of buccal Misoprostol 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




Primary Outcome Measures :
  1. Complete pregnancy evacuation on ultrasound at 3 weeks [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140384


Locations
France
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03140384     History of Changes
Other Study ID Numbers: PI2016_843_0033
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics