Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion.

Summary

Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. There is little data to compare the efficacy of concomitant administration of both drugs and different time intervals. This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.

Timeline

Start

2018-03-01

Primary completion

2021-12-30

Completion

2023-12-30

Publications

• Background Creinin MD, Schreiber CA, Bednarek P, Lintu H, Wagner MS, Meyn LA; Medical Abortion at the Same Time (MAST) Study Trial Group. Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. Obstet Gynecol. 2007 Apr;109(4):885-94. doi: 10.1097/01.AOG.0000258298.35143.d2.
• Results Termination of pregnancy with reduced doses of mifepristone. World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation. BMJ. 1993 Aug 28;307(6903):532-7. doi: 10.1136/bmj.307.6903.532.
• Results McKinley C, Thong KJ, Baird DT. The effect of dose of mifepristone and gestation on the efficacy of medical abortion with mifepristone and misoprostol. Hum Reprod. 1993 Sep;8(9):1502-5. doi: 10.1093/oxfordjournals.humrep.a138287.
• Results Creinin MD, Schwartz JL, Pymar HC, Fink W. Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial. BJOG. 2001 May;108(5):469-73. doi: 10.1111/j.1471-0528.2001.00117.x.
• Results World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation; Special Programme of Research, Development and Research Training; World Health Organisation. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomised trial. BJOG. 2000 Apr;107(4):524-30. doi: 10.1111/j.1471-0528.2000.tb13273.x.
• Results Creinin MD, Fox MC, Teal S, Chen A, Schaff EA, Meyn LA; MOD Study Trial Group. A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion. Obstet Gynecol. 2004 May;103(5 Pt 1):851-9. doi: 10.1097/01.AOG.0000124271.23499.84.
• Results von Hertzen H, Piaggio G, Wojdyla D, Marions L, My Huong NT, Tang OS, Fang AH, Wu SC, Kalmar L, Mittal S, Erdenetungalag R, Horga M, Pretnar-Darovec A, Kapamadzija A, Dickson K, Anh ND, Tai NV, Tuyet HT, Peregoudov A; WHO Research Group on Post-ovulatory Methods of Fertility Regulation. Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial. BJOG. 2009 Feb;116(3):381-9. doi: 10.1111/j.1471-0528.2008.02034.x.
• Results Garg G, Takkar N, Sehgal A. Buccal versus vaginal misoprostol administration for the induction of first and second trimester abortions. J Obstet Gynaecol India. 2015 Apr;65(2):111-6. doi: 10.1007/s13224-014-0605-5. Epub 2014 Oct 31.
• Results Murthy AS, Creinin MD, Harwood B, Schreiber C. A pilot study of mifepristone and misoprostol administered at the same time for abortion up to 49 days gestation. Contraception. 2005 May;71(5):333-6. doi: 10.1016/j.contraception.2004.10.006.
• Results Goel A, Mittal S, Taneja BK, Singal N, Attri S. Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2011 Jun;283(6):1409-13. doi: 10.1007/s00404-011-1881-2. Epub 2011 Mar 23.
• Results Schaff E. Evidence for shortening the time interval of prostaglandin after mifepristone for medical abortion. Contraception. 2006 Jul;74(1):42-4. doi: 10.1016/j.contraception.2006.03.014. Epub 2006 May 12.
• Results Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception. 2001 Aug;64(2):81-5. doi: 10.1016/s0010-7824(01)00229-3.
• Results Wedisinghe L, Elsandabesee D. Flexible mifepristone and misoprostol administration interval for first-trimester medical termination. Contraception. 2010 Apr;81(4):269-74. doi: 10.1016/j.contraception.2009.09.007. Epub 2009 Oct 29.
• Braverman M, Dayan-Schwartz A, Ben-David Y, Kachta O, Zafran N. Early Pregnancy Termination with Mifepristone and Misoprostol: Concurrent vs. 48-Hour Interval Administration in a Randomized Controlled Trial. J Clin Med. 2025 Oct 27;14(21):7616. doi: 10.3390/jcm14217616.

Drugs

Indications

No indication recorded.