drugset / Trial / NCT06502158
Mifepristone vs Misoprostol
RandomizedParallel-groupOpen-labelTreatment
Summary
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.
Timeline
- Start
- 2024-10-31
- Primary completion
- 2026-10
- Completion
- 2026-10
Publications
- Background Allen RH, Goldberg AB. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). Contraception. 2016 Apr;93(4):277-291. doi: 10.1016/j.contraception.2015.12.001. Epub 2015 Dec 9.
- Background Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev. 2010 Feb 17;2010(2):CD007207. doi: 10.1002/14651858.CD007207.pub2.
- Background Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.
- Background Ashok PW, Flett GM, Templeton A. Mifepristone versus vaginally administered misoprostol for cervical priming before first-trimester termination of pregnancy: a randomized, controlled study. Am J Obstet Gynecol. 2000 Oct;183(4):998-1002. doi: 10.1067/mob.2000.106767.
- Background Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.
- Background Ohannessian A, Baumstarck K, Maruani J, Cohen-Solal E, Auquier P, Agostini A. Mifepristone and misoprostol for cervical ripening in surgical abortion between 12 and 14 weeks of gestation: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:151-5. doi: 10.1016/j.ejogrb.2016.04.007. Epub 2016 Apr 11.
- Background Diedrich JT, Drey EA, Newmann SJ. Society of Family Planning clinical recommendations: Cervical preparation for dilation and evacuation at 20-24 weeks' gestation. Contraception. 2020 May;101(5):286-292. doi: 10.1016/j.contraception.2020.01.002. Epub 2020 Jan 31.
- Background Ranji, U., Diep, K., & Salganicoff, A. (2023). Key Facts on Abortion in the United States. Retrieved from https://www.kff.org/womens-health-policy/report/key-factson- abortion-in-the-united-states/#Where-do-people-get-abortion-care.
- Background Jones RK, Kirstein M, Philbin J. Abortion incidence and service availability in the United States, 2020. Perspect Sex Reprod Health. 2022 Dec;54(4):128-141. doi: 10.1363/psrh.12215. Epub 2022 Nov 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifepristone | Small molecule | 200 mg | — |
| Subject | Misoprostol | Other / unclassified | 600 ug | — |
Indications
No indication recorded.