drugset / Trial / NCT02012491
Comparative Effectiveness of Pregnancy Failure Management Regimens
Phase 3
Completed
300 enrolled
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2014-01
- Primary completion
- 2017-05-15
- Completion
- 2019-06-15
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mifepristone | Small molecule | 200 mg | Oral |
| Comparator | Misoprostol | Other / unclassified | 800 ug | Other |