Objective: to compare methotrexate (MTX) to laparoscopic salpingotomy for conservative management of ectopic pregnancy (EP).
Design: prospective randomized study.
Patients: eighty-nine patients were randomized into 2 groups using a random number table. Inclusion criteria were an EP visualized by ultrasound with a pretherapeutic score < or = 13 as assessed by 6 criteria graded from 1 to 3: gestational age, hCG level, P level, abdominal pain, volume of the hemoperitoneum, and diameter of the hematosalpinx.
Interventions: 1 mg/kg of MTX injected transvaginally into the ectopic pregnancy without anaesthesia or IM administration (1.5 mg/kg) when EP cannot be safely or easily punctured (group 1) versus laparoscopic salpingotomy (group 2).
Results: the success rates defined by hCG levels returned to normal (< 10 mlU/mL) were 43 out of 46 in group 1 and 40 out of 43 in group 2. Medical treatment was significantly associated with shorter post-operative stay (24 vs 46 hours). hCG return to normal was quicker after laparoscopic treatment (13 vs 29 days). Reproductive performances were similar in both groups.
Conclusions: in selected cases of EP with a pretherapeutic score < or = 13, MTX treatment appeared to be as safe and efficient as was conservative treatment by laparoscopy, an expectant management should be offered as a treatment option only in women fulfilling the criteria for a good prognostic.