Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of bleeding days per month
研究概览
简要总结
The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device.
Excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.There are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane causes vasoconstriction and blood clotting.
Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen.
The most recent systematic review found NSAIDs is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. The Cochrane Review also found that NSAIDs are the most effective treatment to reduce the bleeding with copper intrauterine device use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women have menorrhagia secondary to IUD.
- •Planning for birth spacing for at least 1 year.
- •Patient aged between 20-45 years old.
- •No history of any medical treatment.
- •Living in a nearby area to make follow-up reasonably possible.
排除标准
- •Evidence of defective coagulation.
- •History or evidence of malignancy.
- •Hyperplasia in the endometrial biopsy.
- •Incidental adnexal abnormality on ultrasound.
- •Untreated abnormal cervical cytology
- •contraindications to ibuprofen
研究组 & 干预措施
Ibuprofen
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Number of bleeding days per month
时间窗: 3 months
by menstrual diary
次要结局
- Uterine Doppler indices(3 months)
