NCT04905251

Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: Linepharma International LTD · Industry
• Sex: Female
• Age: 16 Years – 55 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Medical Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone-Misoprostol	Non interventional design.

Timeline

• Start date: 2022-02-19
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2021-05-27
• Last updated: 2025-02-10

Locations

6 sites across 1 country: Canada