Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-19

Study Completion Date

2024-02-20

Brief Summary

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National multi-center non interventional study aiming at investigating the effectiveness and safety of the combination mifepristone-misoprostol prescribed in Canada to women for medical termination of pregnancy at or before 63 days gestational age through a multi-center prospective non interventional study design.

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Detailed Description

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Primary Objectives:

* Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age, defined as complete abortion without further intervention within 14 days of mifepristone administration
* Safety of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age, defined as the rate of significant Treatment Emergent Adverse Events (TEAE) as a composite outcome of the following events: 1. Hospital Admission; 2. Treatment in Emergency Room; 3. Blood Transfusion; 4. Infection requiring IV Antibiotics, Admission, or Surgical debridement; 5. Death; 6. Ongoing intrauterine pregnancy; 7. Ectopic pregnancy.

Secondary objectives:

* To determine the rate of ongoing pregnancy within 14 days after the administration of mifepristone
* To determine the rate of surgical aspiration performed at the follow-up and time since mifepristone administration
* To determine the reasons for surgical aspiration
* To evaluate the follow-up rate
* To evaluate the delay between the scheduled and actual treatment administration
* To determine the overall safety profile of mifepristone-misoprostol combination
* To evaluate the impact of the demographic characteristics (prescription site, region, gestational age) on effectiveness and safety
* To evaluate the impact of gestational age on effectiveness and safety
* To evaluate the impact of treatment self-administration on effectiveness and safety
* To evaluate the impact of the method and timing of determining gestational age on effectiveness and safety

Study population:

Study performed on a stratified sample of sequential participants (n=3,000) who fulfill trial selection criteria and provide informed consent across a range of clinical practices in Canada (n=30)

Conditions

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Medical Abortion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mifepristone-Misoprostol

Non interventional design.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Women who:

* request elective pregnancy termination in one of the sites participating into the study
* are prescribed mifepristone-misoprostol for this purpose
* provide informed consent to participate in the study.

Exclusion Criteria

* Participant who is unable to understand or comply with Health Care Professional instructions or medical abortion regimen
* Participant who is unable or unwilling to provide written informed consent.

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No