Trial · NCT04905251
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days of gestational age | 14 to 28 days | Defined as complete abortion without further intervention within 14 days of mifepristone administration. |
| Primary | Safety of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age | 14 to 28 days | 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 | Rate of ongoing pregnancy | 14 to 28 days | 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. |
| Secondary | Rate of surgical aspiration | 14-28 days | Description of the frequency (n and percentage of surgical abortion) |
| Secondary | Reasons for surgical aspiration | 14-28 days | Frequency of the following indications: Ongoing pregnancy, Persistent gestational sac, Retained products of conception, Severe bleeding , Pelvic pain, Suspicion of ectopic pregnancy, others |
| Secondary | Delay between the scheduled and actual treatment administration | 14 days | 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 |
| Secondary | Overall safety profile of mifepristone-misoprostol combination | 14-28 days | 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 |
| Secondary | Impact of the demographic characteristics on effectiveness and safety | 14-28 days | 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 |
| Secondary | Impact of gestational age on effectiveness and safety | 14-28 days | 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 |
| Secondary | Impact of treatment self-administration on effectiveness and safety | 14-28 days | 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 |
| Secondary | Impact of the method and timing of determining gestational age on effectiveness and safety | 14-28 days | 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)). |
| Secondary | Follow-up rate | 28 days | 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) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04905251/registered