Tranexamic Acid Versus Calcium Dobesilate for the Treatment of Copper Intra Uterine Contraceptive Device Associated Heavy Menstrual Blood Loss : A Randomized , Open-labelled , Clinical Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Percent of women requesting treatment for heavy menstrual blood loss.
研究概览
简要总结
Intrauterine contraceptive device is the most commonly reversible method used among women of reproductive age worldwide. Almost one in five married contraceptive users is currently using Intrauterine contraceptive device. The Egyptian demographic and health survey results indicate that 30% of currently married women interviewed in the Egyptian demographic and health survey were using Intrauterine contraceptive device. Main reasons for discontinuation of Intrauterine contraceptive device as cited by women were excessive bleeding per vagina 39.68%, abdominal pain 38.62%, low backache35.97%.
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
- •Women usingsopperT380A and reporting heavy menstrual blood loss during use.
- •Menorrhagia , will be defined as a Pictorial blood loss assessment chart-Score greater than
- •No contraindication to drugs used in treatment.
- •No other cause for heavy menstrual blood loss
排除标准
- •Refusing to participate.
- •Irregular menstrual cycle.
- •Misplaced Intrauterine device.
研究组 & 干预措施
Tranexamic Acid
Tranexamic Acid oral tablets 500 mg every six hour with the onset of the first day of menstrual cycle till the end of bleeding for 3 cycles
干预措施: Tranexamic Acid 500 MG (Drug)
Calcium Dobesilate
Calcium Dobesilate oral tablets 500 mg (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.
干预措施: Calcium Dobesilate (Drug)
结局指标
主要结局
Percent of women requesting treatment for heavy menstrual blood loss.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
principal investigator
Assiut University