NCT00194272已完成3 期
Two-Dose Methotrexate for Ectopic Pregnancy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Prevalence of side effects
研究概览
简要总结
This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.
详细描述
The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of ectopic pregnancy via
- •D&E without products of conception identified on frozen pathology or
- •VABRA without products of conception identified with pathologic evaluation or
- •Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole
- •the subject is hemodynamically stable without signs of hemoperitoneum
- •laparoscopy has not been performed
- •the subject is able to return for frequent follow-up care
- •normal renal and liver function have been documented within 2 days
- •normal white blood count and platelet count have been documented as per laboratory standard
- •normal chest x-ray was obtained if the subject has a history of pulmonary disease
- •no history of allergy or sensitivity to methotrexate or any component of its formulation
排除标准
- •breastfeeding
- •laboratory evidence of immunodeficiency
- •alcoholism or chronic liver disease
- •the concomitant use of non-steroidal anti-inflammatory drugs
- •blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia
- •active pulmonary disease
- •hepatic, renal, or hematological dysfunction
- •adnexal mass > or = 3.5 cm
- •presence of fetal cardiac motion
- •active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction
- •subjects unable or unwilling to comply with study procedures or illiterate
结局指标
主要结局
Prevalence of side effects
时间窗: Till quantitative bhCG values fall to zero or below 5mIU/mL
次要结局
- Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)(Till quantitative bhCG values fall to zero or below 5mIU/mL)
研究者
研究点 (6)
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