Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion

Study Overview
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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.

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)

Official Title
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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

Conditions
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Medical Abortion

Intervention / Treatment
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* Drug: Mifepristone-Misoprostol


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mifepristone-Misoprostol|Non interventional design.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days of gestational age | Defined as complete abortion without further intervention within 14 days of mifepristone administration. | 14 to 28 days | 
| 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. | 14 to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ongoing pregnancy | Frequency of ongoing pregnancy documented at the first follow-up visit within 14 days after mifepristone administration. The method used to document the completion of abortion and the intervention proposed in case of ongoing pregnancy will also be recorded. | 14 to 28 days | 
| Rate of surgical aspiration | Description of the frequency (n and percentage of surgical abortion) | 14-28 days | 
| Reasons for surgical aspiration | Frequency of the following indications: Ongoing pregnancy, Persistent gestational sac, Retained products of conception, Severe bleeding , Pelvic pain, Suspicion of ectopic pregnancy, others | 14-28 days | 
| Delay between the scheduled and actual treatment administration | Measure of the time (in days) between the date scheduled at the initial visit and the actual date of administration of mifepristone. Measure of the time (in hour) between the actual administration of misoprostol and the actual administration of mifepristone. Description of the rate of mifepristone administration after 63 weeks of gestational age | 14 days | 
| Overall safety profile of mifepristone-misoprostol combination | Frequency of the following: TEAEs /Serious TEAEs (STEAEs) included in the composite criteria, Hysterectomy, Asthma resistant to common drugs, Cardiovascular event, Skin rash, angioedema, anaphylaxis,, Seizure, Suicide, Potential consequences of ongoing pregnancy exposed to mifepristone +/- misoprostol, All other serious adverse events (SAEs) described by System, Organ, Class (SOC) and Preferred Term (PT) , All other TEAE described by SOC and PT | 14-28 days | 
| Impact of the demographic characteristics on effectiveness and safety | Comparison of the rates of the primary effectiveness and safety endpoints according to the following stratified parameters: Health Care Professional's site: 1) Abortion Clinic 2) Hospital 3) Private practice 4) Other Type of Health Care Professional: 1) Specialist, 2) General Practitioner, 3) Nurse, 4) Other Participant location : rural vs. urban Geographic area of the prescribing site according to Canadian province | 14-28 days | 
| Impact of gestational age on effectiveness and safety | Comparison of the rates of the primary effectiveness and safety endpoints according to gestational age at the time of actual mifepristone administration according to the following stratification: ≤ 35 days 36-49 days 50-63 days > 63 days | 14-28 days | 
| Impact of treatment self-administration on effectiveness and safety | Comparison of the rates of the primary effectiveness and safety endpoints according to the location at which mifepristone is taken: At the study site At home | 14-28 days | 
| Impact of the method and timing of determining gestational age on effectiveness and safety | Comparison of the rates of the primary effectiveness and safety endpoints according to the fact that ultra-sonography was performed (or not) to confirm gestational age and rule out ectopic pregnancy. Description of the mean timing of gestational age determination by ultra-sonography (in weeks of amenorrhea) according to the primary endpoints (existence of complete abortion (yes/no) and of significant treatment emergent adverse event (yes/no)). | 14-28 days | 
| Follow-up rate | The follow-up rate will be assessed up to 28 days after mifepristone administration by describing the rate of: Attendance at the in-person follow-up visit between 7 and 14 days after mifepristone administration Attendance at a remote follow-up visit (phone call) up to 28 days after mifepristone administration Loss to follow-up (inability to contact participant up to 28 days following mifepristone administration) | 28 days |