Medical AbortionMiMACNCT04905251
Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion
An observational study of Medical Abortion, run by Linepharma International LTD at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Mifepristone-Misoprostol
- How many people
- 129 participants
- Where
- 6 sitesCanada
- Study dates
- 19 Feb 2022to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Centennial Primary Care
Kentville, Nova Scotia, B4N 1C2
Manitoulin Health Centre
Mindemoya, Ontario, P0P 1S0
Family Planning Clinic, Moncton City Hospital
Moncton, New Brunswick, E1C 6Z8
Mud Creek Medical
New Minas, Nova Scotia, B4N 3R7
Women's College Hospital
Toronto, Ontario, M5S 1B2
Choice in Health Clinic
Toronto, Ontario, M6P 1A9
About this study
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
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.
Read the 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)
- Conditions
- Medical Abortion
- Being tested
- Mifepristone-Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone-MisoprostolDrug
Non interventional design.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 to 28 days
Secondary outcomes (10)
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.
Measured: 14 to 28 days
Rate of surgical aspiration
Description of the frequency (n and percentage of surgical abortion)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)).
Measured: 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)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start19 Feb 2022
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linepharma International LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dustin COSTESCU, MDMS FRCSC, Principal investigator, McMaster University Medical Centre - Hamilton ON Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905251
- Sponsor's protocol ID
- LPI011
- Acronym
- MiMAC
- Status last verified
- Feb 2025
- First submitted
- 24 May 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04905251
- Acronym / sponsor ID
- MiMAC / LPI011
- Conditions
- Medical Abortion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Linepharma International LTDIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2022 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone-MisoprostolNon interventional design. | Drug | – |
Primary outcome
Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days of gestational age
Time frame: 14 to 28 days
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
Time frame: 14 to 28 days
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.
10 secondary outcomes
Rate of ongoing pregnancy
Time frame: 14 to 28 days
Rate of surgical aspiration
Time frame: 14-28 days
Reasons for surgical aspiration
Time frame: 14-28 days
Delay between the scheduled and actual treatment administration
Time frame: 14 days
Overall safety profile of mifepristone-misoprostol combination
Time frame: 14-28 days
Impact of the demographic characteristics on effectiveness and safety
Time frame: 14-28 days
Impact of gestational age on effectiveness and safety
Time frame: 14-28 days
Impact of treatment self-administration on effectiveness and safety
Time frame: 14-28 days
Impact of the method and timing of determining gestational age on effectiveness and safety
Time frame: 14-28 days
Follow-up rate
Time frame: 28 days
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Related trials for Medical Abortion
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruiting
'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial
Medical Abortion
Not yet recruiting
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
Missed Abortion, Early Pregnancy Loss
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dustin COSTESCU, MDMS FRCSC principal investigator
McMaster University Medical Centre - Hamilton ON Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Abortion, run by Linepharma International LTD at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days of gestational age (time frame: 14 to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.