Efficacy and safety of misoprostol compared to methotrexate plus misoprostol for the medical management of abortion in Bogotá, Colombia. A randomized clinical trial

Authors

  • Mortimer Arreaza-Graterol
  • Jorge A. Rodríguez-O

DOI:

https://doi.org/10.18597/rcog.251

Keywords:

retained abortion, anembryonic pregnancy, medical management, misoprostol, methotrexate

Abstract

Objective: evaluating the efficacy and safety of misoprostol compared to methotrexate plus misoprostol for the medical management of patients suffering from retained abortion/anembryonic pregnancy.

Materials and methods: this was a randomized clinical experiment. Patients having a gestational age of less than 63 days who were suffering anembryonic pregnancy/retained abortion as diagnosed by ecography were included. They were randomized into 2 groups receiving 50 mg intramuscular methotrexate plus 800 mcg intravaginal misoprostol (group 1) or 800 mcg intravaginal misoprostol (group 2). The complete abortion rate was evaluated, including patients who required a rescue dose with their respective complications.

Results: a total of 52 patients were randomized to the combined therapy group and 66 to the monotherapy group; 92% presented complete abortion by ecography in the misoprostol plus methotrexate group and 86% in the misoprostol group (p=0.24). Two of the patients from the combined therapy group (6%) required a rescue dose compared to five in the misoprostol group (11%) (p=0.348). Three patients required obstetric uterine dilation and curettage (D&C) (in the combined therapy group whilst five needed it in the monotherapy with misoprostol group (p=0.69). Both schemes proved safe for the patients.

Conclusions: the profile for medical management of females having a gestational age of less than 63 days who were diagnosed as having retained abortion or anembryonic pregnancy receiving intravaginal 800 mcg de misoprostol monodosis did not show significant differences when compared to a combined methotrexate and misoprostol therapy scheme.

Author Biographies

Mortimer Arreaza-Graterol

Gineco-obstetra, Universidad El Bosque. Bogotá (Colombia)

Jorge A. Rodríguez-O

Gineco-obstetra. Epidemiólogo Clínico, Universidad El Bosque. Coordinador Académico de Gineco-obstetricia, Hospital Simón Bolívar. Bogotá (Colombia)

References

Alberman E. Spontaneous abortions: epidemiology. En: Stabile I, Grudzinskas G, Chard T, eds. Spontaneous abortion: diagnosis and treatment. London: Springer-Verlag, 1992. p. 19-20.

Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, Frederick MM, et al. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med 2005;353:761-9.

Hertig AT, Livingstone RG. Spontaneous, threatened, and habitual abortion: their pathogenesis and treatment. N Engl J Med 1944;230:797-806.

Macrow P, Elstein M. Managing miscarriage medically. BMJ 1993;306:876.

Ballagh SA, Harris HA, Demasio K. Is curettage needed for uncomplicated incomplete spontaneous abortion? Am J Obstet Gynecol 1998;179:1279-82.

Rådestad A, Christensen NJ, Strömberg L. Induced cervical ripening with Mifepristone in first trimester abortion. A double-blind randomized biomechanical study. Contraception 1988;38:301-12.

Norman JE, Thong KJ, Baird DT. Uterine contractility and induction of abortion in early pregnancy by misoprostol and mifepristone. Lancet 1997;338:1233-6.

Ozeren M, Bilekli C, Aydemir V, Bozkaya H. Methotrexate and misoprostol used alone or in combination for early abortion. Contraception 1999;59:389-94.

Creinin MD, Vittinghoff E, Keder L, Darney PD, Tiller G. Methotrexate and misoprostol for early abortion: a multicenter trial. Safety and efficacy. Contraception 1996;53:321-7.

Haber y Runyon "Estadísticas Generales", primera página de tabla de números aleatorios. 2da. Edición. Los Angeles, USA: Edit. Fondo Educativo Interamericano; 1973.

Creinin MD, Vittinghoff E, Galbraith S, Klaisle C. A randomized trial comparing Misoprostol 3 and 7 days following methotrexate for early abortion. Am J Obstet Gynecol 1995;173:1578-84.

Coughlin LB, Roberts D, Haddad NG, Long A. Medical management of first trimester miscarriage (blighted ovum and missed abortion): is it effective? J Obstet Gynecol 2004;24:69-71.

Grønlund A, Grønlund L, Clevin L, Andersen B, Palmgren N, Lidegaard Ø. Management of missed abortion: comparison of medical treatment with either mifepristone + misoprostol or misoprostol alone with surgical evacuation. A multi-center trial in Copenhagen County, Denmark. Acta Obstet Gynecol Scand 2002;81:1060-5.

Wood SL, Brain PH. Medical management of missed abortion: a randomized clinical trial. Int J Gynecol Obstet 2002;99:563-6.

Kovavisarach E, Jamnansiri C. Ointravaginal misoprostol 600 µg and 800 µg for the treatment of early pregnancy failure. Int J Gynaecol Obstet 2005;90;208-12.

Chia KV, Ogbo VI. Medical termination of missed abortion. J Obstet Gynaecol 2002;22:184-6.

Ayres de Campos D, Teixeira-da-Silva J, Campos I, Patrício B. Vaginal misoprostol in the management of first-trimester missed abortions. Int J Gynecol Obstet 2000;71:53-7.

Ulmann A, Silvestre L, Chemama L, Rezvani Y, Renault M, Aguillaume CJ, et al. Medical termination of early pregnancy with mifepristone (RU 486) followed by a prostaglandin analogue Study in 16,369 women. Acta Obstet Gynecol Scand 1992;71:278-83.

American College of Obstetricians and Gynecologists. ACOG Practice Bulletin. Number 104. Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol 2009;113:1180-9.

Sawaya GF, Grady D, Kerlikowske K, Grimes DA. Antibiotics at the time of induced abortion: the case for universal prophylaxis based on a meta-analysis. Obstet Gynecol 1996;87:884-90.

American College Of Obstetricians And Gynecologists. ACOG Practice Bulletin. Number 94. Medical management of ectopic pregnancies. Obstet Gynecol 2008;111:1479-85.

How to Cite

1.
Arreaza-Graterol M, Rodríguez-O JA. Efficacy and safety of misoprostol compared to methotrexate plus misoprostol for the medical management of abortion in Bogotá, Colombia. A randomized clinical trial. Rev. colomb. obstet. ginecol. [Internet]. 2010 Dec. 20 [cited 2024 May 19];61(4):295-302. Available from: https://revista.fecolsog.org/index.php/rcog/article/view/251

Downloads

Download data is not yet available.

Published

2010-12-20

Issue

Section

Original Research
QR Code

Altmetric

Article metrics
Abstract views
Galley vies
PDF Views
HTML views
Other views
Crossref Cited-by logo

Some similar items: