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Insufficient Enrollment for Meaningful Analysis/Incomplete or Inconclusive Data Collection. Reaching desired participation numbers of subjects and site was determined to be unfeasible within the two year time period the study was intended to last.
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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.
Primary Objectives:
Secondary objectives:
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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone-Misoprostol | Drug | Non interventional design. |
| 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 |
| 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 |
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Inclusion criteria
Women who:
Exclusion Criteria:
pregnant women
Stratified sample of sequential pregnant women requesting medical abortion under 63 days of gestation, who fulfill trial selection criteria and provide informed consent across a range of clinical practices in Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Dustin COSTESCU, MDMS FRCSC | McMaster University Medical Centre - Hamilton ON Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Planning Clinic, Moncton City Hospital | Moncton | New Brunswick | E1C 6Z8 | Canada | ||
| Centennial Primary Care |
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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:
| 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:
| 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:
| 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:
| 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:
| 28 days |
| Kentville |
| Nova Scotia |
| B4N 1C2 |
| Canada |
| Mud Creek Medical | New Minas | Nova Scotia | B4N 3R7 | Canada |
| Manitoulin Health Centre | Mindemoya | Ontario | P0P 1S0 | Canada |
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
| Choice in Health Clinic | Toronto | Ontario | M6P 1A9 | Canada |