Computational protocol: Therapeutic outcomes of methotrexate injection in unruptured interstitial pregnancy

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Protocol publication

[…] This study was approved by the institutional review board of CHA Gangnam Medical Center (GCI-15-13). After obtaining institutional review board approval, the authors retrospectively reviewed the medical records of the patients who were diagnosed with interstitial pregnancy and underwent MTX treatment at CHA Gangnam Medical Center between January 2003 and July 2014. We collected patient demographics, treatment regimen, doses administered, treatment results, and subsequent pregnancy outcomes. In our institution, the diagnosis of interstitial pregnancy was made by transvaginal ultrasonography (TVU) using the following criteria: 1) no visible gestational sac within the uterus; 2) a gestational sac visualized in the fundus that is not surrounded by >5 mm of myometrium in all planes; and 3) a gestational sac seen separately and <1 cm from the most lateral edge of the uterine cavity.Non-surgical treatment consisted of a systemic intramuscular MTX injection with or without a local MTX injection (1 mg/kg body weight) into an ectopic lesion under TVU guidance. For the systemic MTX injection, various regimens such as an 8-day alternating MTX regimen (1 mg/kg intramuscularly on days 1, 3, 5, and 7) [], a single-dose MTX regimen (50 mg/m2 intramuscularly on day 1) [], and a high-dose MTX regimen (100 mg/m2 + 200 mg/m2 intravenously over 12 hours) [] have been used since 2003 ().For the local injection of MTX, patients emptied their bladders, prepared aseptically, and placed in the lithotomy position. Under propofol anesthesia, the ultrasonography probe was placed along the posterior wall of the vagina and directed at the interstitial ectopic mass. Using a 17-gauge 35-cm aspiration needle (Cook Australia, Queensland, Australia), a needle puncture into the gestational sac, followed by the injection of MTX (1 mg/kg body weight) into the gestational sac []. The presence of hemoperitoneum was checked before and after treatment. The procedure was well tolerated by patients and no major complications were recorded.Treatment success was defined as the resolution of serum beta-human chorionic gonadotropin (β-hCG) levels without the need for surgical intervention. Treatment failure was identified if the patient required surgery.The statistical analysis was performed using International Business Machines (IBM) Statistical Package for the Social Sciences statistics software version 22 (SPSS; IBM Corp., Armonk, NY, USA). The Mann-Whitney U test and χ2 test were performed to compare intergroup differences. The statistical analysis was also used to identify predictive factors of MTX treatment success of interstitial pregnancy. Values of P<0.05 were considered statistically significant. The statistical power was calculated using G*POWER 3.1.9.2 (Institut für Psychologie, Christian-Albrechts-Universität zu Kiel, Kiel, Germany). […]

Pipeline specifications

Software tools SPSS, G*Power
Application Miscellaneous
Organisms Homo sapiens