كارآزمايي تصادفي متوتركيبات تك دوز در برابر سالينگوستوفي لاپاراسكوپيك در درمان حاملگي نابجاي پاره نشده

Randomized Trial of Single - Dose Methotrexate Versus Laparoscopic Salpingostomy in the Treatment of Unruptured Ectopic Pregnancy

Background: Regarding the prevalence of ectopic pregnancy, complications due to surgery and contradictory reports on efficacy of methotrexate in ectopic pregnancy treatment, this study was carried out to compare the effect of single - dose methotrexate (MTX) and laparoscopic salpingostomy (L.S) in the treatment of unruptured ectopic pregnancy (UEP) in Tehran from 2002 to 2004. Materials & Methods: Through a prospective randomized clinical trial 40 eligible women with small UEP (less than 3.5 cm) were randomly assigned to 2 groups. Following their informed consent the first group was treated with single-dose MTX (50 mg/m2) l.M (n=20), while the other group underwent laparoscopic salpingostomy (n=20). All subjects had initial, day 4, 7 and weekly serum level taken until HCG levels were less than 10 IU/L. A single - dose MTX (or an additional dose) was given if post treatment day 7 HCG levels decreased by 15% as compared with day 4 levels. Success rate was defined as HCG resolution without the need for the alternate mode of therapy. The results were analysed through T-test exact Fischer test chiʹ. Results: the success rate was 95% in each group. The median resolution time was 28 (range: 7- 49) and 17.5 (range: 7- 35) days for MTX and L.S groups, respectively. This difference was not statisticaly significant. The pattern of resolution of HCG serum levels in MTX group revealed an initial increase (from day 0 to day 4). In contrast all women in L.S group, had experienced immediate decrease in HCG levels after surgery. No serious complications were seen in either of two groups. Conclusion: Single - dose MTX has a success rate as high as laparoscopic salpingostomy in the treatment of unruptured ectopic pregnancy. Thus, methotrexate application is suggested in case of inaccessibity to laparoscopy.