Trial · NCT02012491
Comparative Effectiveness of Pregnancy Failure Management Regimens
NCT02012491, Phase 3, Completed, University of Pennsylvania; results first posted 2018-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Effectiveness of Pregnancy Failure Management Regimens. Trials, record NCT02012491. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02012491
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness of Pregnancy Failure Management Regimens
- NCT number
- NCT02012491
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Spontaneous Abortion
- Interventions
- Misoprostol, Mifepristone
- First posted
- 2013-12-16
- Last updated
- 2019-07-18
- Results first posted
- 2018-12-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. | Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done | |
| Primary | Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 | Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical) | |
| Primary | Gestational Sac Expulsion by the 30-day Telephone Call | 30 Days | |
| Primary | Uterine Asperation | 30 Days | Surgical removal of the miscarriage. |
| Secondary | Frequency of Serious Adverse Events Between Study Arms. | 30 days | |
| Secondary | Adverse Event Reported by Participants | 30 Days |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. | Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 | Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Gestational Sac Expulsion by the 30-day Telephone Call | 30 Days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Uterine Asperation | 30 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency of Serious Adverse Events Between Study Arms. | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Event Reported by Participants | 30 Days | adverse events | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. | Misoprostol | 100 | Participants | ||
| Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. | Misoprostol Plus Mifepristone | 124 | Participants | ||
| Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 | Misoprostol | 111 | Participants | ||
| Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 | Misoprostol Plus Mifepristone | 132 | Participants | ||
| Gestational Sac Expulsion by the 30-day Telephone Call | Misoprostol | 113 | Participants | ||
| Gestational Sac Expulsion by the 30-day Telephone Call | Misoprostol Plus Mifepristone | 135 | Participants | ||
| Uterine Asperation | Misoprostol | 35 | Participants | ||
| Uterine Asperation | Misoprostol Plus Mifepristone | 13 | Participants | ||
| Frequency of Serious Adverse Events Between Study Arms. | Misoprostol | 3 | Participants | ||
| Frequency of Serious Adverse Events Between Study Arms. | Misoprostol Plus Mifepristone | 5 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Misoprostol | 151 | |
| Overall Study | STARTED | Misoprostol Plus Mifepristone | 149 | |
| Overall Study | COMPLETED | Misoprostol | 149 | |
| Overall Study | COMPLETED | Misoprostol Plus Mifepristone | 148 | |
| Overall Study | NOT COMPLETED | Misoprostol | 2 | |
| Overall Study | NOT COMPLETED | Misoprostol Plus Mifepristone | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Misoprostol | 115 | 151 | |
| other | Fatigue | General disorders | Misoprostol Plus Mifepristone | 118 | 149 | |
| serious | Bleeding resulting in blood transfusion | Blood and lymphatic system disorders | Misoprostol | 1 | 151 | 1 |
| serious | Bleeding resulting in blood transfusion | Blood and lymphatic system disorders | Misoprostol Plus Mifepristone | 3 | 149 | 3 |
| serious | Pelvic Infection | Reproductive system and breast disorders | Misoprostol | 2 | 151 | 2 |
| serious | Pelvic Infection | Reproductive system and breast disorders | Misoprostol Plus Mifepristone | 2 | 149 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Misoprostol | 0 | 151 |
| Total, all-cause mortality | Misoprostol Plus Mifepristone | 0 | 149 |
| Total, other adverse events | Misoprostol | 115 | 151 |
| Total, other adverse events | Misoprostol Plus Mifepristone | 118 | 149 |
| Total, serious adverse events | Misoprostol | 3 | 151 |
| Total, serious adverse events | Misoprostol Plus Mifepristone | 5 | 149 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD071920 | Comparative Effectiveness of Pregnancy Failure Management Regimens (Pre-Fai-R) | SCHREIBER, COURTNEY A. | UNIVERSITY OF PENNSYLVANIA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2013 to 2017 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Misoprostol vs Misoprostol Plus Mifepristone: Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. | Trial comparisons |
| Misoprostol vs Misoprostol Plus Mifepristone: Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 | Trial comparisons |
| Misoprostol vs Misoprostol Plus Mifepristone: Gestational Sac Expulsion by the 30-day Telephone Call | Trial comparisons |
| Misoprostol vs Misoprostol Plus Mifepristone: Frequency of Serious Adverse Events Between Study Arms. | Trial comparisons |
| Misoprostol vs Misoprostol Plus Mifepristone: Uterine Asperation | Trial comparisons |
| Misoprostol vs Misoprostol Plus Mifepristone: deaths from any cause | Trial comparisons |
| Misoprostol vs Misoprostol Plus Mifepristone: serious adverse events | Trial comparisons |
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/NCT02012491
GET https://conductscience.org/api/trials/v1/NCT02012491/registered