Effectiveness & Safety of Combination Mifepristone/Misoprostol for Medical

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Medical Abortion

Clinical Trial Details

NCT number	NCT04905251
Study type	Observational
Source	Linepharma International LTD
Contact	Delphine JAQUET, MD PhD
Phone	+33786299178
Email	d.jaquet@linepharma-lab.com
Status	Recruiting
Phase
Start date	February 22, 2022
Completion date	December 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT02745093` - Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks	Phase 4
Completed	`NCT02570204` - Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests	N/A
Completed	`NCT01487213` - Routine Follow-up Versus Self-assessment in Medical Abortion	N/A
Terminated	`NCT05119439` - Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks	Phase 4
Terminated	`NCT04941443` - Methadone and Medication Abortion	Phase 4
Completed	`NCT02985229` - Acceptability and Feasibility of Medical Abortion in Singapore	Phase 3
Completed	`NCT01920022` - Quickstart of Nexplanon® at Medical Abortion	Phase 4
Completed	`NCT00472394` - Determining Women's Preferences for Medical Abortion Using Willingness to Pay	N/A
Completed	`NCT03604341` - Cannabinoids for Pain Control During Medical Abortion	Phase 4
Completed	`NCT00907725` - Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?	N/A
Completed	`NCT00120224` - De-Medicalizing Mifepristone Medical Abortion	N/A
Completed	`NCT03148587` - Medical Abortion Self-Confirmation (MASC)	N/A
Completed	`NCT00621543` - Insertion of an Intrauterine Device (IUD) After Medical Abortion	N/A
Completed	`NCT02343913` - Simplifying Menstrual Regulation (MR): Post Abortion Care in Pakistan	N/A
Completed	`NCT01856777` - Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy	N/A
Recruiting	`NCT00920465` - Treatment Regimens for Mifegyne and Cytotec	Phase 3
Completed	`NCT05532085` - Assessment of Pain During an Abortion With Knowledge of the Predictive Factors of Pain.
Completed	`NCT00997347` - The Extended Gestational Age Medical Abortion Study	Phase 4
Completed	`NCT03014193` - Simplifying First Trimester Medical Abortion Follow-up	N/A
Completed	`NCT04181541` - Midlevel Versus Physician-provided Medical Abortion in the Second Trimester	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms