Mifepristone in combination with methotrexate for the medical treatment of tubal pregnancy: a randomized, controlled trial

Abstract

In the search for a more potent alternative to a single i.m. injection of methotrexate for ectopic pregnancy, a randomized trial was organized. The efficacy of a combination of methotrexate and mifepristone was compared with methotrexate alone in the treatment of unruptured tubal pregnancies. The diagnosis of an unruptured tubal pregnancy was confirmed laparoscopically in 50 patients during a 2 year period. Women were randomized to receive a single i.m. injection of 50 mg/m2 methotrexate alone or a single dose of 600 mg oral mifepristone in combination with the same dose of methotrexate. Both treatment protocols were successful in achieving the resolution of unruptured ectopic pregnancy (18/25 in the methotrexate group and 22/25 in the combination group) following the initial intervention. A second injection was needed in four (16%) cases in the methotrexate group and in one (4%) case in the combination group. Overall, a complete resolution was achieved in 22/25 and 23/25 cases respectively. Unruptured ectopic pregnancy resolved faster in women given the combination of methotrexate and mifepristone compared to women given methotrexate only (P = 0.01). The effect of the methotrexate and mifepristone combination was more pronounced in women with higher human chorionic gonadotrophin concentrations.

Predictors of success in methotrexate treatment of women with unruptured tubal pregnancies

“…This lack of confirmation for 23% of the EPs may explain the differences in the results between these two series. Our results with IM administration are similar to those published by Stika21, who reported a success rate of 78% in a retrospective study of 50 patients and to those in randomized trials comparing IM administration alone with IM administration combined with mifepristone27, 28. Analysis of our series thus indicates that the administration route is an independent factor for success, regardless of the initial hCG level.…”

Prise en charge diagnostique et thérapeutique des grossesses extra-utérines

“…L'adjonction de 600 mg de mifépristone (RU486) au MTX intramusculaire n'augmenterait pas les chances de succès [10,11]. L'essai thérapeutique français [11] retrouve un avantage au RU486 dans le sous-groupe des GEU actives défi-nies par des taux de PG supérieurs à 10 ng/ml.…”

Peut-on traiter 74 % des grossesses extra-utérines par un traitement médical ? À propos d’une série de 202 patientes

“…En revanche, dans les études de Lipscomb et al et Millad et al, la taille de la GEU n'est corrélée ni à la réussite du traitement, ni à l'évolutivité de la grossesse [19,20]. La présence d'un épanchement péri-tonéal n'apparaît pas être un facteur prédictif, dans notre série comme dans la littérature [21]. En revanche, la pré-sence d'une activité cardiaque est dans la série présentée comme dans la littérature, corrélée à un taux de succès moindre [9,18,19].…”