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)
Study Type
OBSERVATIONAL
Enrollment
129
Non interventional design.
Family Planning Clinic, Moncton City Hospital
Moncton, New Brunswick, Canada
Centennial Primary Care
Kentville, Nova Scotia, Canada
Mud Creek Medical
New Minas, Nova Scotia, Canada
Manitoulin Health Centre
Mindemoya, Ontario, Canada
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.
Time frame: 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.
Time frame: 14 to 28 days
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.
Time frame: 14 to 28 days
Rate of surgical aspiration
Description of the frequency (n and percentage of surgical abortion)
Time frame: 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
Time frame: 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
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Women's College Hospital
Toronto, Ontario, Canada
Choice in Health Clinic
Toronto, Ontario, Canada
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)).
Time frame: 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)
Time frame: 28 days