Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion

NCT04905251 | Terminated DMC

• 1 other identifier: LPI011
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 6

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.

Conditions

Medical Abortion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Rate of ongoing pregnancy

  14 to 28 days

• Rate of surgical aspiration

  14-28 days

• Reasons for surgical aspiration

  14-28 days

• Delay between the scheduled and actual treatment administration

  14 days

• Overall safety profile of mifepristone-misoprostol combination

  14-28 days

Interventions

Mifepristone-Misoprostol DRUG

Non interventional design.

Eligibility Criteria

• Age: 16 Years - 55 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linepharma International LTD: lead

Study Sites (6)

Family Planning Clinic, Moncton City Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Centennial Primary Care

Kentville, Nova Scotia, B4N 1C2, Canada

Location

Mud Creek Medical

New Minas, Nova Scotia, B4N 3R7, Canada

Location

Manitoulin Health Centre

Mindemoya, Ontario, P0P 1S0, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Choice in Health Clinic

Toronto, Ontario, M6P 1A9, Canada

Location

Study Officials

• Dustin COSTESCU, MDMS FRCSC

  McMaster University Medical Centre - Hamilton ON Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: February 19, 2022
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CA (6)