Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD071920-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| misoprostol plus mifepristone | Active Comparator | 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior |
|
| misoprostol | Active Comparator | 800 micrograms of vaginal misoprostol alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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) | |
| Gestational Sac Expulsion by the 30-day Telephone Call | 30 Days | |
| Uterine Asperation | Surgical removal of the miscarriage. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Serious Adverse Events Between Study Arms. | 30 days | |
| Adverse Event Reported by Participants | 30 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Courtney A Schreiber, MD, MPH | University of Pennsylvania | Principal Investigator |
| Mitchell Creinin, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35780811 | Derived | Nagendra D, Gutman SM, Koelper NC, Loza-Avalos SE, Sonalkar S, Schreiber CA, Harvie HS. Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration. Am J Obstet Gynecol. 2022 Nov;227(5):737.e1-737.e11. doi: 10.1016/j.ajog.2022.06.054. Epub 2022 Jun 30. | |
| 33930380 | Derived | Roe AH, McAllister A, Flynn AN, Martin B, Jiang E, Koelper N, Schreiber CA. The effect of mifepristone pretreatment on bleeding and pain during medical management of early pregnancy loss. Contraception. 2021 Oct;104(4):432-436. doi: 10.1016/j.contraception.2021.04.023. Epub 2021 Apr 28. |
Not provided
Not provided
Not provided
We randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, orally, followed by 800 μg of misoprostol, administered vaginally (mifepristone-pretreatment group), or 800 μg of misoprostol alone, administered vaginally (misoprostol-alone group).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol | 800 micrograms of vaginal misoprostol alone Misoprostol |
| FG001 | Misoprostol Plus Mifepristone | 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol | 800 micrograms of vaginal misoprostol alone Misoprostol |
| BG001 | Misoprostol Plus Mifepristone | 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done |
|
Adverse events were collected over a 30 day time frame
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Misoprostol | 800 micrograms of vaginal misoprostol alone Misoprostol | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding resulting in blood transfusion | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Courtney Schreiber | University of Pennsylvania | 215-615-5234 | Courtney.Schreiber@uphs.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2017 | Aug 28, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mifepristone |
| Drug |
|
|
| The Bronx |
| New York |
| 10461 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| 33278280 | Derived | Shorter JM, Koelper N, Sonalkar S, Oquendo MA, Sammel MD, Schreiber CA. Racial Disparities in Mental Health Outcomes Among Women With Early Pregnancy Loss. Obstet Gynecol. 2021 Jan 1;137(1):156-163. doi: 10.1097/AOG.0000000000004212. |
| 32305259 | Derived | Sonalkar S, Koelper N, Creinin MD, Atrio JM, Sammel MD, McAllister A, Schreiber CA. Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial. Am J Obstet Gynecol. 2020 Oct;223(4):551.e1-551.e7. doi: 10.1016/j.ajog.2020.04.006. Epub 2020 Apr 17. |
| 32215633 | Derived | Nagendra D, Koelper N, Loza-Avalos SE, Sonalkar S, Chen M, Atrio J, Schreiber CA, Harvie HS. Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201594. doi: 10.1001/jamanetworkopen.2020.1594. |
| 30531561 | Derived | Clement EG, Horvath S, McAllister A, Koelper NC, Sammel MD, Schreiber CA. The Language of First-Trimester Nonviable Pregnancy: Patient-Reported Preferences and Clarity. Obstet Gynecol. 2019 Jan;133(1):149-154. doi: 10.1097/AOG.0000000000002997. |
| 29874535 | Derived | Schreiber CA, Creinin MD, Atrio J, Sonalkar S, Ratcliffe SJ, Barnhart KT. Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. N Engl J Med. 2018 Jun 7;378(23):2161-2170. doi: 10.1056/NEJMoa1715726. |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Only females where included in this study. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Primary | Uterine Asperation | Surgical removal of the miscarriage. | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | Frequency of Serious Adverse Events Between Study Arms. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Adverse Event Reported by Participants | Posted | Mean | Full Range | adverse events | 30 Days |
|
|
|
| 151 |
| 3 |
| 151 |
| 115 |
| 151 |
| EG001 | Misoprostol Plus Mifepristone | 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone | 0 | 149 | 5 | 149 | 118 | 149 |
| Pelvic Infection | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |