Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- success of treatment
研究概览
简要总结
Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was > 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hemodynamic stability
- •Initial β-hCG <2000 mIU / mL
- •Titers of β-hCG in decline in 48 hours before treatment
- •Adnexal mass <5.0 cm
- •Desire for future pregnancy
排除标准
- •Alive embryo
- •Ectopic pregnancy other than in tubal location
- •Pregnancy of unknown location
研究组 & 干预措施
Methotrexate
Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.
干预措施: Methotrexate (Drug)
Placebo
Prescribed Placebo intramuscularly.
干预措施: Placebo (Drug)
结局指标
主要结局
success of treatment
时间窗: 6 months
β-hCG negative (\<5 mIU / mL)
Time required for titers of β-hCG to become negative
时间窗: 6 weeks
After medication, monitoring will be done by measurement of β-hCG in the 4th and 7th day. If there ia a decrease \> 15% in this range (4th and 7th), patient will be followed with weekly dosing of β-hCG until negative titers
次要结局
- Blood tests before treatment with Methotrexate and Placebo(6 months)
- Blood tests after treatment with Methotrexate and Placebo(6 months)
研究者
Priscila Matthiesen e Silva
Obstetrics and Gynecologist
Federal University of São Paulo