Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 18
- 主要终点
- Subsequent fertility with 2 years follow-up
研究概览
简要总结
Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.
详细描述
The first group includes non active ectopic pregnancies defined by score or algorithm. In this case, we propose a randomized controlled trial between medical and conservative surgery. In all others clinical situations, we proposed surgery treatment. In a randomized controlled trial we compare conservative versus radical treatment. The patients are followed-up during 2 years with phone contact every 6 months.
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
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis by ultra sound of ectopic pregnancy (EP)
- •Patients aged > 18 years old
- •Desire of future pregnancy
排除标准
- •EP by failure of contraception
- •EP associated with in vitro fertilization (IVF)
结局指标
主要结局
Subsequent fertility with 2 years follow-up
次要结局
- Complications of treatments
- Time of hospitalisation
- Decrease curve of beta-hCG after treatment
- Success rate in each group