Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion (MiMAC)

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.

Study Overview

• Status: Recruiting
• Conditions: Medical Abortion
• Intervention / Treatment: Drug: Mifepristone-Misoprostol

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Delphine JAQUET, MD PhD; Phone Number: +33786299178; Email: d.jaquet@linepharma-lab.com
• Study Contact Backup: Name: Marion ULMANN, JD; Phone Number: +14379981980; Email: m.ulmann@linepharma-lab.com

Study Locations

• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Recruiting
      • Family Planning Clinic, Moncton City Hospital
      • Contact: Physician, MD; Phone Number: 506-855-6700
  • Nova Scotia
    • Kentville, Nova Scotia, Canada, B4N 1C2
      • Recruiting
      • Centennial Primary Care
      • Contact: Nurse Practitioner; Email: Jennifer.lawton@nshealth.ca
    • New Minas, Nova Scotia, Canada, B4N 3R7
      • Recruiting
      • Mud Creek Medical
      • Contact: Physician; Phone Number: 902 542 3633
  • Ontario
    • Mindemoya, Ontario, Canada, P0P 1S0
      • Recruiting
      • Manitoulin Health Centre
      • Contact: Nurse Practitioner; Phone Number: 705-377-5371
    • Toronto, Ontario, Canada, M5S 1B2
      • Recruiting
      • Women's College Hospital
      • Contact: Physician; Phone Number: 416-351-3726
    • Toronto, Ontario, Canada, M6P 1A9
      • Recruiting
      • Choice in Health Clinic
      • Contact: Study Coordinator; Phone Number: 905 818 1755
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 5T1
      • Not yet recruiting
      • Women's Wellness Program and Sexual Services
      • Contact: Nurse Practitioner; Email: klarter@ihis.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: 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	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	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	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	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: 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)	28 days

Collaborators and Investigators

• Sponsor: Linepharma International LTD
• Investigators: Principal Investigator: Dustin COSTESCU, MDMS FRCSC, McMaster University Medical Centre - Hamilton ON Canada

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: LPI011