Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Time for serum b-hCG remission
研究概览
简要总结
This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.
详细描述
Ectopic pregnancy is considered a life-threatening condition which requires immediate intervention. Owing to the advancements in medical technology, ectopic pregnancy can now be diagnosed in the early stages.
Methotrexate (MTX) is an antimetabolite drug showing a competitive reversible binding concerning natural dihydrofolates and acting as an inhibitor of the dihydrofolate-reductase (DHFR), a key enzyme synthesizing the tetrahydrofolates needed for the synthesis of purine and pyrimidine rings.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 20 to 40 years.
- •Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy).
- •Gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hCG) levels are less than 10,000 mIU/mL.
排除标准
- •Patients with basal beta hCG levels less than 1500 mIU/Ml.
- •Any contraindications to MTX as a hepatic disorder, renal disorder and thrombocytopenia
- •Diabetes mellitus.
- •Severe vaginal bleeding or hemodynamic changes or hemoperitoneum.
- •History of cancer.
- •Pleural effusion.
研究组 & 干预措施
Systemic Methotrexate
Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).
干预措施: Systemic Methotrexate (Drug)
Local Methotrexate
Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).
干预措施: Local Methotrexate (Drug)
结局指标
主要结局
Time for serum b-hCG remission
时间窗: Post intervention for 3 months
Time for serum b-hCG remission will be recorded to be less than 20 iu/ml.
次要结局
- Success rate(Post intervention for 3 months)
- Time for uterine-mass disappearance(Post intervention for 3 months)
- Hospitalization time(15 days after intervention)
研究者
Mai Nabil Ageez
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University