Original Paper

25 mg or 50 mg of Oral Methotrexate Followed by Vaginal Misoprostol 7 Days after for Early Abortion
A Randomized Trial
J.L. Carbonell Esteve^a, L. Varela^b, A. Velazco^b, R. Tanda^b, C. Sánchez<sup>b

a</sup>Family Planning Center approved by the 'Consellería de Sanitat i Consum', Generalitat Valenciana, for pregnancy termination 'Mediterrania Medica', Valencia, Spain;
^bHospital Docente Gineco-Obstétrico 'Eusebio Hernández' (Maternidad Obrera), Cuiudad de la Habana, Cuba

Address of Corresponding Author

Gynecol Obstet Invest 1999;47:182-187 (DOI: 10.1159/000010090)

  Key Words

• Medical abortion
• Methotrexate
• Misoprostol

  Abstract

Background: Several combinations of oral or intravenous methotrexate plus vaginal misoprostol have been used for early abortion with success rates varying widely. So far, any study has evaluated the efficacy and safety of lower doses of oral methotrexate followed by vaginal misoprostol for early abortion. Objectives: To evaluate the efficacy and safety of methotrexate 25 or 50 mg orally and 800 µg of misoprostol vaginally 7 days after the methotrexate for abortion at 56 days of gestation. Study Design: Three-hundred and ten pregnant women seeking elective abortion were randomly allocated to receive 25 mg (group I) or 50 mg (group II) of methotrexate orally and 800 µg of misoprostol vaginally 7 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side effects and vaginal bleeding. Relative risks were used for the comparison between the outcomes from both treatment regimens. Results: In group I aborted 135/148 cases (91%, 95% CI 85, 95%), and 139/154 cases (90%, 95% CI 84, 94%) aborted in group II (relative risk [RR] = 1.01, RR 95% CI 0.94, 1.09). Conclusions: The two treatment regimens showed the same efficacy and safety, so it would be advisable at least to use the smaller methotrexate dose, i.e. 25 mg.

  Author Contacts

Dr. Josep Lluis Carbonell Esteve
Clínica Mediterrania Medica, C/Maestro Sosa, 22 baix
E-46007 Valencia (Spain)
Tel. +34 96 341 86 00, Fax +34 96 341 40 55
E-Mail mediterrania@xarxaneta.org

  Article Information

Received: Received: March 17, 1998
Accepted: June 16, 1998
Number of Print Pages : 6
Number of Figures : 0, Number of Tables : 4, Number of References : 21