Trial · NCT04905251
Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion
NCT04905251, Terminated, Linepharma International LTD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion. Trials, record NCT04905251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04905251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion
- NCT number
- NCT04905251
- Status
- Terminated
- Enrollment
- 129 participants, actual
- Lead sponsor
- Linepharma International LTD
- Conditions
- Medical Abortion
- Interventions
- Mifepristone-Misoprostol
- First posted
- 2021-05-27
- Last updated
- 2025-02-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04905251
GET https://conductscience.org/api/trials/v1/NCT04905251/registered