Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 10:34 AM
Study NCT ID:
NCT04905251
Status:
TERMINATED
Last Update Posted:
2025-02-10
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion
Sponsor:
Linepharma International LTD
Organization:
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MiMAC
Brief Summary:
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:
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)
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: