Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion

Last updated: February 6, 2025
Sponsor: Linepharma International LTD
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Mifepristone-Misoprostol

Clinical Study ID

NCT04905251
LPI011
  • Ages 16-55
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria

Women who:

  • request elective pregnancy termination in one of the sites participating into thestudy

  • are prescribed mifepristone-misoprostol for this purpose

  • provide informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  • Participant who is unable to understand or comply with Health Care Professionalinstructions or medical abortion regimen

  • Participant who is unable or unwilling to provide written informed consent.

Study Design

Total Participants: 129
Treatment Group(s): 1
Primary Treatment: Mifepristone-Misoprostol
Phase:
Study Start date:
February 19, 2022
Estimated Completion Date:
February 20, 2024

Study 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;

    1. 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)

Connect with a study center

  • Family Planning Clinic, Moncton City Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Centennial Primary Care

    Kentville, Nova Scotia B4N 1C2
    Canada

    Site Not Available

  • Mud Creek Medical

    New Minas, Nova Scotia B4N 3R7
    Canada

    Site Not Available

  • Manitoulin Health Centre

    Mindemoya, Ontario P0P 1S0
    Canada

    Site Not Available

  • Choice in Health Clinic

    Toronto, Ontario M6P 1A9
    Canada

    Site Not Available

  • Women's College Hospital

    Toronto, Ontario M5S 1B2
    Canada

    Site Not Available

  • Women's Wellness Program and Sexual Services

    Charlottetown, Prince Edward Island C1A 5T1
    Canada

    Site Not Available

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