Background Medical termination of pregnancy can be successfullyperformed with a combination of mifepristone (RU 486) and aprostaglandin analogue. We conducted a prospective, randomizedtrial to compare oral with vaginal administration of the prostaglandinE1 analogue misoprostol for first-trimester abortion in womentreated initially with mifepristone.
Methods The study population consisted of 270 women seekingabortion within 63 days after the onset of amenorrhea. The doseof mifepristone was 600 mg, and the dose of misoprostol was800 µg. The study had two primary end points: expulsionof 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 surgicalprocedure occurred in 95 percent of the women who received misoprostolvaginally and in 87 percent of those who received it orally(P = 0.03). The rate of continued pregnancy was 7 percent withthe oral regimen and 1 percent with the vaginal regimen (P =0.01). Ninety-three percent of the women receiving misoprostolvaginally had abortions within four hours, as compared withonly 78 percent of the women receiving the drug orally (P<0.001).Vomiting and diarrhea were reported more frequently by the womenwho received oral misoprostol than by those who received vaginalmisoprostol (P = 0.04 and P = 0.002, respectively).
Conclusions After the administration of mifepristone, vaginaladministration of misoprostol is more effective and better toleratedthan oral administration for the induction of first-trimesterabortion.
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.
Bennett, I. M., Baylson, M., Kalkstein, K., Gillespie, G., Bellamy, S. L., Fleischman, J.
(2009). Early Abortion in Family Medicine: Clinical Outcomes. Ann Fam Med
7: 527-533
[Abstract][Full Text]
Tang, O. S., Schweer, H., Lee, S. W.H., Ho, P. C.
(2009). Pharmacokinetics of repeated doses of misoprostol. Hum Reprod
24: 1862-1869
[Abstract][Full Text]
(2009). Modern Methods of Abortion. JWatch Women's Health
2009: 1-1
[Full Text]
Saav, I., Aronsson, A., Marions, L., Stephansson, O., Gemzell-Danielsson, K.
(2007). Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial. Hum Reprod
22: 2647-2652
[Abstract][Full Text]
Aronsson, A., Fiala, C., Stephansson, O., Granath, F., Watzer, B., Schweer, H., Gemzell-Danielsson, K.
(2007). Pharmacokinetic profiles up to 12 h after administration of vaginal, sublingual and slow-release oral misoprostol. Hum Reprod
22: 1912-1918
[Abstract][Full Text]
Trinder, J, Brocklehurst, P, Porter, R, Read, M, Vyas, S, Smith, L
(2006). Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ
332: 1235-1240
[Abstract][Full Text]
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]
Fiala, C., Aronsson, A., Granath, F., Stephansson, O., Seyberth, H.W., Watzer, B., Gemzell-Danielsson, K.
(2005). Pharmacokinetics of a novel oral slow-release form of misoprostol. Hum Reprod
20: 3414-3418
[Abstract][Full Text]
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]
Davis, A.R., Robilotto, C.M., Westhoff, C.L., Forman, S., Zhang, J., for the NICHD Management of Early Pregnancy Failur,
(2004). Bleeding patterns after vaginal misoprostol for treatment of early pregnancy failure. Hum Reprod
19: 1655-1658
[Abstract][Full Text]
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]
Tang, O. S., Chan, C. C.W., Ng, E. H.Y., Lee, S. W.H., Ho, P. C.
(2003). A prospective, randomized, placebo-controlled trial on the use of mifepristone with sublingual or vaginal misoprostol for medical abortions of less than 9 weeks gestation. Hum Reprod
18: 2315-2318
[Abstract][Full Text]
Tang, O. S., Lau, W. N. T., Ng, E. H. Y., Lee, S. W. H., Ho, P. C.
(2003). A prospective randomized study to compare the use of repeated doses of vaginal with sublingual misoprostol in the management of first trimester silent miscarriages. Hum Reprod
18: 176-181
[Abstract][Full Text]
Zikopoulos, K.A., Papanikolaou, E.G., Kalantaridou, S.N., Tsanadis, G.D., Plachouras, N.I., Dalkalitsis, N.A., Paraskevaidis, E.A.
(2002). Early pregnancy termination with vaginal misoprostol before and after 42 days gestation. Hum Reprod
17: 3079-3083
[Abstract][Full Text]
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]
Honkanen, H., Ranta, S., Ylikorkala, O., Heikinheimo, O.
(2002). The kinetics of serum hCG and progesterone in response to oral and vaginal administration of misoprostol during medical termination of early pregnancy. Hum Reprod
17: 2315-2319
[Abstract][Full Text]
Tang, O. S., Xu, J., Cheng, L., Lee, S. W.H., Ho, P. C.
(2002). Pilot study on the use of sublingual misoprostol with mifepristone in termination of first trimester pregnancy up to 9 weeks gestation. Hum Reprod
17: 1738-1740
[Abstract][Full Text]
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]
Tang, O. S., Miao, B.Y., Lee, S. W.H., Ho, P. C.
(2002). Pilot study on the use of repeated doses of sublingual misoprostol in termination of pregnancy up to 12 weeks gestation: efficacy and acceptability. Hum Reprod
17: 654-658
[Abstract][Full Text]
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]
Ashok, P. W., Kidd, A., Flett, G. M.M., Fitzmaurice, A., Graham, W., Templeton, A.
(2002). A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation. Hum Reprod
17: 92-98
[Abstract][Full Text]
Shan Tang, O., Xu, J., Cheng, L., Lee, S. W.H., Chung Ho, P.
(2002). The effect of contraceptive pills on the measured blood loss in medical termination of pregnancy by mifepristone and misoprostol: a randomized placebo controlled trial. Hum Reprod
17: 99-102
[Abstract][Full Text]
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]
Wagaarachchi, P.T., Ashok, P.W., Narvekar, N., Smith, N.C., Templeton, A.
(2001). Medical management of early fetal demise using a combination of mifepristone and misoprostol. Hum Reprod
16: 1849-1853
[Abstract][Full Text]
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]
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]
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]