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Effectiveness of expectant management versus methotrexate in tubal ectopic pregnancy: a double-blind randomized trial

  • Gynecologic Endocrinology and Reproductive Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

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/m2 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.

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Authors and Affiliations

  1. 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

    Priscila Matthiesen Silva, Edward Araujo Júnior, Gustavo Nardini Cecchino, Julio Elito Júnior & Luiz Camano

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  1. Priscila Matthiesen Silva
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  2. Edward Araujo Júnior
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  3. Gustavo Nardini Cecchino
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  4. Julio Elito Júnior
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  5. Luiz Camano
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Correspondence to Edward Araujo Júnior.

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Silva, P.M., Araujo Júnior, E., Cecchino, G.N. et al. Effectiveness of expectant management versus methotrexate in tubal ectopic pregnancy: a double-blind randomized trial. Arch Gynecol Obstet 291, 939–943 (2015). https://doi.org/10.1007/s00404-014-3513-0

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  • DOI: https://doi.org/10.1007/s00404-014-3513-0

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