Methotrexate versus placebo in early tubal ectopic pregnancies: a double-blinded randomised trial

epean Hospital0 个研究点目标入组 76 人开始时间: 2018年7月10日最近更新: 2019年8月26日

适应症

试验速览

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•Haemodynamically stable patients, with a visible tubal EP on transvaginal ultrasound (an ectopic gestational sac with or without the embryo, or an ectopic mass) and serum hCG concentrations rising after 48 hours observation and below 1500 IU/L are eligible for the trial. This hCG cut-off level is based on previous uncontrolled and controlled studies on single dose MTX. We have adopted inclusion criteria widely used in studies on MTX17. Using these criteria, we estimate approximately 24% of all EPs will be eligible for entry in the trial. Patients of all ages will be considered eligible.

•Patients with declining hCG, a viable EP (embryonic cardiac activity on ultrasound), severe abdominal pain and/or peritonism, haemodynamic instability, evidence of significant haemoperitoneum on scan (> 300ml, blood above the uterine fundus and/or in the Morison's pouch) or contraindications to MTX (leukopaenia, thrombocytopaenia, or elevated serum liver enzymes or creatinine) are not included.

发起方

epean Hospital