Clinical trial NCT04905251: Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Medical Abortion
Lead sponsor: Linepharma International LTD
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 129
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days of gestational age
timeFrame: 14 to 28 days
measure: Safety of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age
timeFrame: 14 to 28 days
Secondary outcomes:
measure: Rate of ongoing pregnancy
timeFrame: 14 to 28 days
measure: Rate of surgical aspiration
timeFrame: 14-28 days
measure: Reasons for surgical aspiration
timeFrame: 14-28 days
measure: Delay between the scheduled and actual treatment administration
timeFrame: 14 days
measure: Overall safety profile of mifepristone-misoprostol combination
timeFrame: 14-28 days
measure: Impact of the demographic characteristics on effectiveness and safety
timeFrame: 14-28 days
measure: Impact of gestational age on effectiveness and safety
timeFrame: 14-28 days
measure: Impact of treatment self-administration on effectiveness and safety
timeFrame: 14-28 days
measure: Impact of the method and timing of determining gestational age on effectiveness and safety
timeFrame: 14-28 days
measure: Follow-up rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Moncton
country: Canada
facility: Family Planning Clinic, Moncton City Hospital
state: New Brunswick
city: Kentville
country: Canada
facility: Centennial Primary Care
state: Nova Scotia
city: New Minas
country: Canada
facility: Mud Creek Medical
state: Nova Scotia
city: Mindemoya
country: Canada
facility: Manitoulin Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: Choice in Health Clinic
state: Ontario
Study officials:
affiliation: McMaster University Medical Centre - Hamilton ON Canada
name: Dustin COSTESCU, MDMS FRCSC
role: PRINCIPAL_INVESTIGATOR
References: