OJOG  Vol.2 No.1 , March 2012
A prospective randomized, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy
ABSTRACT
A prospective randomized, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Author: Dr Roopa Malik, Assistant Professor, Obstetrics and gynaecology department Pt BDS PGIMS Rohtak BACKGROUND: Vaginal misoprostol has been shown to be an effective single agent for medical agent for medical abortion. This randomized, placebo controlled trial compared a regimen of mefipristone and misoprostol with misoprostol alone for termination of early pregnancy. METHODS: 200 women with gestation <56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 ug vaginal misoprostol. Abortion success was defined as complete abortion without the use of surgical aspiration. RESULTS: Successful medical abortions occurred in 96 out of 100 subjects (96%) after mifepristone followed by vaginal misoprostol. In all, 79 out of 100 subjects (79%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (p < 0.05). CONCLUSION: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies <56 days than misoprostol alone. The misoprostol alone regimen for termination of early pregnancy is not a very good method for medical abortion but 79% efficacy obtained with vaginal misoprostol alone may clinically acceptable when mifepristone is not available.

Cite this paper
Malik, R. , Kumar, V. , Sangwan, V. and Nanda, S. (2012) A prospective randomized, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Open Journal of Obstetrics and Gynecology, 2, 81-84. doi: 10.4236/ojog.2012.21016.
References
[1]   World Health Organization (2004) Unsafe abortion-global and regional estimates of the incidence of unsafe abortion and associated mortality in 2000. 4th Edition, WHO, 82.

[2]   Avrech, O.M., Golan, A. and Weinraub, Z. (1991) Mefipristone alone or in combination with an analogue for termination of early pregnancy: A review. Fertility and Sterility, 56, 385-393.

[3]   Jain, J.K., Dutton, C. and Harwood, B. (2002) A prospective randomized, double blinded, placebo-controlled trial comparing, mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Human Reproduction, 17, 1477-1482. doi:10.1093/humrep/17.6.1477

[4]   Carbonell, J.L., Varela, L. and Velazco, A. (1997) The use of misoprostol for termination of early pregnancy. Contraception, 55, 165-168. doi:10.1016/S0010-7824(97)00020-6

[5]   Carbonell, J.L., Varela, L. and Velazco, A. (1997) The use of misoprostol for abortion at <9 weeks gestation. European Journal of Contraception and Reproductive Health Care, 2, 181-185. doi:10.3109/13625189709167474

[6]   Bugalho, A., Mocumbi, S., Faundes, A. and David, E. (2000) Termination of pregnancies of <6 weeks gestation with a single dose of 800ug of vaginal misoprostol. Contraception, 61, 47-50. doi:10.1016/S0010-7824(99)00116-X

[7]   Esteve, J.L., Varela, L. and Velazco, A. (1999) Early abortion with 800ug of misoprostol by vagonal route. Contraception, 59, 219-225. doi:10.1016/S0010-7824(99)00032-3

[8]   Jain, J.K., Meckstroth, K.R. and Mishell, D.R. Jr. (1999) Early pregnancy termination with intravaginally administered sodium chloride solution-moistened misoprostol tablets: Historical comparison with mifepristone and oral misoprostol. American Journal of Obstetrics & Gynecology, 181, 1386-1391. doi:10.1016/S0002-9378(99)70380-7

[9]   Nagai, S.W., Tang, O.S. and Chan, Y.M. (2000) Vaginal misoprostol alone for medical abortion up to 9 weeks of gestation: Efficacy and acceptability. Human Reproduction, 15, 1159-1162. doi:10.1093/humrep/15.5.1159

[10]   Jain, J.K., Harwood, B., Meckstroth, K.R. and Mishell, D.R. Jr. (2001) Early pregnancy termination with vaginal misoprostol combined with loperamide and acetaminophen prophylaxis. Contraception, 63, 217-221. doi:10.1016/S0010-7824(01)00193-7

[11]   Schaff, E.A., DiCenzo, R. and Fielding, S.L. (2005) Comparison of misoprostol plasma concentrations following buccal and sublingual administration. Contraception, 71, 22-25. doi:10.1016/j.contraception.2004.06.014

[12]   Middleton, T., Schaff, E. and Fielding, S.L. (2005) Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Contraception, 72, 328-332. doi:10.1016/j.contraception.2005.05.017

[13]   El Refaey, H., Rajasekar, D. and Abdalla, M. (1995) Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol. The New England Journal of Medicine, 332, 983-987. doi:10.1056/NEJM199504133321502

[14]   Arvidsson, C., Hellborg, M. and Gemzell-Danielsson, K. (2005) Preference and acceptability of oral versus vaginal administration of misoprostol in medical abortion with mifepristone. European Journal of Obstetrics & Gynecology and Reproductive Biology, 123, 87-91. doi:10.1016/j.ejogrb.2005.02.019

[15]   Fjerstad, M., Sivin, I. and Lichtenberg, E.S. (2009) Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days. Contraception, 80, 282-286. doi:10.1016/j.contraception.2009.03.010

 
 
Top