Sequential Letrozole and Methotrexate Therapy Safely Improved the Outcomes of Medical Treatment of Tubal Ectopic Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The Rate of resolution of Tubal Ectopic Pregnancy (TEP)
研究概览
简要总结
Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP.
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
- Single (Participant)
盲法说明
Patients were divided into 2 Groups as the group titles were printed into cards that were enclosed in sealed envelopes and patients were asked to choose a closed envelop.
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of gestational masses of <3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity;
- •Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of <3500 IU/L.
排除标准
- •Free of Inclusion Criteria
研究组 & 干预措施
Group LTZ-MTX
Letrozole and Methotrexate Therapy's Group
干预措施: Methotrexate (Drug)
Group LTZ-MTX
Letrozole and Methotrexate Therapy's Group
干预措施: Letrozole (Drug)
Group MTX
Methotrexate Therapy's Group
干预措施: Methotrexate (Drug)
结局指标
主要结局
The Rate of resolution of Tubal Ectopic Pregnancy (TEP)
时间窗: 9 months
Role of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery.
次要结局
未报告次要终点
研究者
Walid Mohamed Elnagar
Assistant professor of Gynecology
Zagazig University