PURPOSE: 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). CONCLUSION: 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.
RCT Entities:
PURPOSE: 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). CONCLUSION: 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: G E Colombo; M Leonardi; M Armour; H Di Somma; T Dinh; F da Silva Costa; L Wong; S Armour; G Condous Journal: Hum Reprod Open Date: 2020-10-25
Authors: Kurt T Barnhart; Karl R Hansen; Mary D Stephenson; Rebecca Usadi; Anne Z Steiner; Marcelle I Cedars; Emily S Jungheim; Kathleen M Hoeger; Stephen A Krawetz; Benjie Mills; Meredith Alston; Christos Coutifaris; Suneeta Senapati; Sarita Sonalkar; Michael P Diamond; Robert A Wild; Mitchell Rosen; Mary D Sammel; Nanette Santoro; Esther Eisenberg; Hao Huang; Heping Zhang Journal: JAMA Date: 2021-08-03 Impact factor: 56.272