Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion

Prospective Non Interventional Phase IV Multi-centre Canadian Study on the Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion Under 63 Days Gestation

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.

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)

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.