title: Effectiveness of expectant management versus methotrexate in tubal ectopic pregnancy: a double-blind randomized trial.
abstract: OBJECTIVE
  To compare the effectiveness of expectant management versus methotrexate in selected cases of tubal ectopic pregnancy.
  
  
  METHODS
  A double-blind randomized trial included 23 selected patients with a confirmed diagnosis of tubal pregnancy who met the inclusion criteria (hemodynamic stability, initial serum β-hCG concentration <2,000 mIU/mL, declining titers of β-hCG 48 h prior to treatment, visible tubal pregnancy on transvaginal ultrasound, a tubal mass <5.0 cm and fertility desire). The patients were divided into two groups: 10 patients in the methotrexate group (MTX 50 mg/m(2) administered as a single intramuscular dose) and 13 patients in the placebo group (saline solution administered in a single intramuscular dose). Quantitative variables were expressed as means ± standard deviations and compared by Student's t test or Mann-Whitney test. Dichotomous variables (success/treatment failure) were presented as proportions and compared by the Fisher exact test.
  
  
  RESULTS
  Successful treatment with negative titers of β-hCG occurred in 9 cases (90.0%) of the methotrexate group and in 12 (92.3%) of the placebo group (p > 0.999). The β-hCG values became undetectable at 22 ± 15.4 days in the methotrexate group and 20.6 ± 8.4 days in the placebo group (p = 0.80).
  
  
  CONCLUSIONS
  This study showed no statistically significant difference between the treatment with methotrexate and placebo, with similar success rates and similar time interval for β-hCG to become undetectable.
authors.affiliation: Department of Obstetrics, Paulista School of Medicine, Federal University of São Paulo (EPM-UNIFESP), Rua Carlos Weber 956, apto. 113 Visage, Vila Leopoldina, São Paulo, SP, CEP 05303-000, Brazil.
authors.forename: Priscila Matthiesen
authors.initials: PM
authors.lastname: Silva
authors.forename: Edward
authors.initials: E
authors.lastname: Araujo Júnior
authors.forename: Gustavo Nardini
authors.initials: GN
authors.lastname: Cecchino
authors.forename: Julio
authors.initials: J
authors.lastname: Elito Júnior
authors.forename: Luiz
authors.initials: L
authors.lastname: Camano
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D018997:Chorionic Gonadotropin, beta Subunit, Human / Q000097:blood*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008727:Methotrexate / Q000008:administration & dosage* / Q000627:therapeutic use; D011247:Pregnancy; D011274:Pregnancy, Tubal / Q000097:blood* / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016896:Treatment Outcome; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D018997:Chorionic Gonadotropin, beta Subunit, Human; D008727:Methotrexate