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Previous Volume 332:983-987 April 13, 1995 Number 15 Next

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ABSTRACT

Background Medical termination of pregnancy can be successfully performed with a combination of mifepristone (RU 486) and a prostaglandin analogue. We conducted a prospective, randomized trial to compare oral with vaginal administration of the prostaglandin E₁ analogue misoprostol for first-trimester abortion in women treated initially with mifepristone.

Methods The study population consisted of 270 women seeking abortion within 63 days after the onset of amenorrhea. The dose of mifepristone was 600 mg, and the dose of misoprostol was 800 µg. The study had two primary end points: expulsion of the conceptus without the need for a surgical procedure, and abortion within four hours after the administration of misoprostol.

Results Expulsion of the conceptus without the need for a surgical procedure occurred in 95 percent of the women who received misoprostol vaginally and in 87 percent of those who received it orally (P = 0.03). The rate of continued pregnancy was 7 percent with the oral regimen and 1 percent with the vaginal regimen (P = 0.01). Ninety-three percent of the women receiving misoprostol vaginally had abortions within four hours, as compared with only 78 percent of the women receiving the drug orally (P<0.001). Vomiting and diarrhea were reported more frequently by the women who received oral misoprostol than by those who received vaginal misoprostol (P = 0.04 and P = 0.002, respectively).

Conclusions After the administration of mifepristone, vaginal administration of misoprostol is more effective and better tolerated than oral administration for the induction of first-trimester abortion.

Source Information

From the Department of Obstetrics and Gynaecology (H.E.-R., D.R., L.C., A.T.) and the Health Service Research Unit (M.A.), Medical School, Aberdeen, Scotland, United Kingdom.

Address reprint requests to Dr. El-Refaey at the Obstetric Hospital, University College Hospital, Huntly St., London WC1E 6AU, United Kingdom.

Full Text of this Article

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Extract | Full Text  
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• Tang, O. S., Ong, C. Y.T., Tse, K. Y., Ng, E. H.Y., Lee, S. W.H., Ho, P. C. (2006). A randomized trial to compare the use of sublingual misoprostol with or without an additional 1 week course for the management of first trimester silent miscarriage. Hum Reprod 21: 189-192 [Abstract] [Full Text]  
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• Fiala, C., Aronsson, A., Stephansson, O., Gemzell-Danielsson, K. (2005). Effects of slow release misoprostol on uterine contractility in early pregnancy. Hum Reprod 20: 2648-2652 [Abstract] [Full Text]  
• Hamoda, H., Ashok, P. W., Flett, G. M.M., Templeton, A. (2005). A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation. Hum Reprod 20: 2348-2354 [Abstract] [Full Text]  
• Shannon, C., Brothers, L P., Philip, N. M., Winikoff, B. (2004). Ectopic Pregnancy and Medical Abortion. Obstet Gynecol 104: 161-167 [Abstract] [Full Text]  
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• Grimes, D. A., Creinin, M. D. (2004). Induced Abortion: An Overview for Internists. ANN INTERN MED 140: 620-626 [Abstract] [Full Text]  
• Bagratee, J.S., Khullar, V., Regan, L., Moodley, J., Kagoro, H. (2004). A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod 19: 266-271 [Abstract] [Full Text]  
• Aronsson, A., Bygdeman, M., Gemzell-Danielsson, K. (2004). Effects of misoprostol on uterine contractility following different routes of administration. Hum Reprod 19: 81-84 [Abstract] [Full Text]  
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• Tang, O. S., Lee, S. W.H., Ho, P. C. (2002). A prospective randomized study on the measured blood loss in medical termination of early pregnancy by three different misoprostol regimens after pretreatment with mifepristone. Hum Reprod 17: 2865-2868 [Abstract] [Full Text]  
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• Jain, J. K., Dutton, C., Harwood, B., Meckstroth, K. R., Mishell, D. R. Jr (2002). A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Hum Reprod 17: 1477-1482 [Abstract] [Full Text]  
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• Tang, O. S., Schweer, H., Seyberth, H.W., Lee, S. W.H., Ho, P. C. (2002). Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod 17: 332-336 [Abstract] [Full Text]  
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• Pang, M.W., Lee, T.S., Chung, T.K.H. (2001). Incomplete miscarriage: a randomized controlled trial comparing oral with vaginal misoprostol for medical evacuation. Hum Reprod 16: 2283-2287 [Abstract] [Full Text]  
• Bartley, J., Brown, A., Elton, R., Baird, D. T. (2001). Double-blind randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation. Hum Reprod 16: 2098-2102 [Abstract] [Full Text]  
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• Demetroulis, C., Saridogan, E., Kunde, D., Naftalin, A. A. (2001). A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure. Hum Reprod 16: 365-369 [Abstract] [Full Text]  
• Goldberg, A. B., Greenberg, M. B., Darney, P. D. (2001). Misoprostol and Pregnancy. NEJM 344: 38-47 [Full Text]  
• Child, T.J., Thomas, J., Rees, M., MacKenzie, I.Z. (2001). A comparative study of surgical and medical procedures: 932 pregnancy terminations up to 63 days gestation. Hum Reprod 16: 67-71 [Abstract] [Full Text]  
• PREUTTHIPAN, S., HERABUTYA, Y. (2000). Vaginal Misoprostol for Cervical Priming Before Operative Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol 96: 890-894 [Abstract] [Full Text]  
• Schaff, E. A., Fielding, S. L., Westhoff, C., Ellertson, C., Eisinger, S. H., Stadalius, L. S., Fuller, L. (2000). Vaginal Misoprostol Administered 1, 2, or 3 Days After Mifepristone for Early Medical Abortion: A Randomized Trial. JAMA 284: 1948-1953 [Abstract] [Full Text]  
• WING, D. A., FASSETT, M. J., MISHELL, D. R. Jr (2000). Mifepristone for Preinduction Cervical Ripening Beyond 41 Weeks' Gestation: A Randomized Controlled Trial. Obstet Gynecol 96: 543-548 [Abstract] [Full Text]  
• Christin-Maitre, S., Bouchard, P., Spitz, I. M. (2000). Medical Termination of Pregnancy. NEJM 342: 946-956 [Full Text]  
• Swahn, M-L., Bygdeman, M., Jun-kang, C., Gemzell-Danielsson, K., Si, S., Qiu-ying, Y., Pei-juan, Y., Mei-ling, Q., Wei-fang, C. (1999). Once-a-month treatment with a combination of mifepristone and the prostaglandin analogue misoprostol. Hum Reprod 14: 485-488 [Abstract] [Full Text]  
• Goldberg, J. R., Plescia, M. G., Anastasio, G. D. (1998). Mifepristone (RU 486): Current Knowledge and Future Prospects. Arch Fam Med 7: 219-222 [Abstract] [Full Text]  
• Miller, N. H., Miller, D. J., Pinkston Koenigs, L. M. (1998). Attitudes of the Physician Membership of the Society for Adolescent Medicine Toward Medical Abortions for Adolescents. Pediatrics 101 : e4-e4 [Abstract] [Full Text]  
• Spitz, I. M., Bardin, C. W., Benton, L., Robbins, A. (1998). Early Pregnancy Termination with Mifepristone and Misoprostol in the United States. NEJM 338: 1241-1247 [Abstract] [Full Text]  
• (1998). Termination of first trimester pregnancy. DTB 36: 13-15 [Abstract] [Full Text]  
• Perrone, J., Hoffman, R. S., Yankowitz, J., Niebyl, J. R., Grunberg, S. M., Swanson, K. T., Levitt, N., Hausknecht, R. (1996). Methotrexate and Misoprostol to Terminate Early Pregnancy. NEJM 334: 399-400 [Full Text]  
• Hausknecht, R. U. (1995). Methotrexate and Misoprostol to Terminate Early Pregnancy. NEJM 333: 537-540 [Abstract] [Full Text]