drugset / Trial / NCT02745093
Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the effectiveness, safety, and acceptability of home-administered medical abortion at gestational age of 8 to ≤9 weeks versus \>9 to ≤12 weeks among a cohort of women in Mexico City.
Timeline
- Start
- 2016-09
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Background Boersma AA, Meyboom-de Jong B, Kleiverda G. Mifepristone followed by home administration of buccal misoprostol for medical abortion up to 70 days of amenorrhoea in a general practice in Curacao. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):61-6. doi: 10.3109/13625187.2011.555568. Epub 2011 Feb 9.
- Background Chen MJ, Creinin MD. Mifepristone With Buccal Misoprostol for Medical Abortion: A Systematic Review. Obstet Gynecol. 2015 Jul;126(1):12-21. doi: 10.1097/AOG.0000000000000897.
- Background Gomperts R, van der Vleuten K, Jelinska K, da Costa CV, Gemzell-Danielsson K, Kleiverda G. Provision of medical abortion using telemedicine in Brazil. Contraception. 2014 Feb;89(2):129-33. doi: 10.1016/j.contraception.2013.11.005. Epub 2013 Nov 12.
- Background Gouk EV, Lincoln K, Khair A, Haslock J, Knight J, Cruickshank DJ. Medical termination of pregnancy at 63 to 83 days gestation. Br J Obstet Gynaecol. 1999 Jun;106(6):535-9. doi: 10.1111/j.1471-0528.1999.tb08320.x.
- Background Hamoda H, Ashok PW, Flett GM, Templeton A. Medical abortion at 9-13 weeks' gestation: a review of 1076 consecutive cases. Contraception. 2005 May;71(5):327-32. doi: 10.1016/j.contraception.2004.10.015.
- Background Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. BJOG. 2005 Aug;112(8):1102-8. doi: 10.1111/j.1471-0528.2005.00638.x.
- Background Kulier R, Kapp N, Gulmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD002855. doi: 10.1002/14651858.CD002855.pub4.
- Background Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review. Bull World Health Organ. 2011 May 1;89(5):360-70. doi: 10.2471/BLT.10.084046. Epub 2011 Mar 4.
- Background Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK138196/
- Background Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifepristone | Small molecule | 200 ug | Oral |
| Subject | Misoprostol | Other / unclassified | 400 ug | Other |
Indications
No indication recorded.