Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- success rate
研究概览
简要总结
Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.
详细描述
Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.
A new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of tubal ectopic pregnancy.
- •Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.
- •Gestational sac with largest diameter as 4cm.
- •Willing to take methotrexate treatment.
- •Willing to follow up.
排除标准
- •Heterotrophic pregnancy
- •Persistent tubal pregnancy
- •Embryonic cardiac motion
- •Suspected tubal rupture
- •Past history of harmful effects of methotrexate treatment on organ functions.
研究组 & 干预措施
two-dose group
Women allocated to two-dose group were administered intramuscular methotrexate as 50mg/m2 at day-zero and 7 while measurement of β-hCG was ordered at day-14.
干预措施: Methotrexate (Drug)
结局指标
主要结局
success rate
时间窗: 4-14 days
In single-dose group,β-hCG levels were measured at day-4 and 7 and if β-hCG decreased \>15% between day-4 and day-7, the treatment was labeled successful. In two-dose group, in case 15% reduction in β-hCG level was observed at day-14, the treatment was labeled as success.
次要结局
- β-hCG Resolution Time(1-14 days)
- frequency of Side-effects of treatment(1-14 days)
研究者
Rashida Parveen
Consultant Gynecologist
Nishtar Medical University