RANDOMIZED TRIAL OF SYSTEMIC METHOTREXATE VERSUS LAPAROSCOPIC SALPINGOSTOMY IN TUBAL PREGNANCY

Background Laparoscopic salpingostomy is a well-established treatment for patients with tubal pregnancy who desire to-retain fertility. Anot her approach that preserves the fallopian tube is medical treatment. W e compared systemic methotrexate and laparoscopic salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success , tubal preservation, and homolateral tubal patency. Methods Between J anuary, 1994, and September, 1996, haemodynamically stable patients wi th laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1.0 mg/kg doses of intramuscular methotrexate alternated with 0.1 mg/k g oral folinic acid) or laparoscopic salpingostomy. Treatment success was defined, as complete elimination of the tubal pregnancy (serum hum an chorionic gonadotropin <2 IU/L) and preservation of the tube. Homol ateral tubal patency was assessed by hysterosalpingography. Analysis w as by intention to treat. Findings 100 patients were included in the t rial. Of 51 patients allocated systemic methotrexate, 42 (82%) were su ccessfully treated with one course; two (4%) patients needed a second course Cor persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these pa tients for tubal rupture. Of the 49 patients allocated laparoscopic sa lpingostomy, 35 (72%) were successfully treated by laparoscopic salpin gostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast, The tube was pr eserved in 46 (90%) methotrexate group versus 45 salpingostomy group ( rate ratio 0.98 [95% CI 0.87-1.1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patien ts in the methotrexate group and in 23 (59%) of 39 patients in the sal pingostomy group (rate ratio 0.93 [0.64-1.4]). Interpretation In haemo dynamically stable patients with unruptured tubal pregnancy, systemic methotrexate and laparoscopic salpingostomy were successful in treatin g the majority of cases. We found no significant difference between th e treatments in the homolateral patency rate. Subsequent fertility out come has to be awaited to show which treatment yields better fertility prospects.