the Effect of Vaginal Isosorbide Mononitrate Administration in Reducing Pain During Cooper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- pain during IUD insertion
研究概览
简要总结
The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous women requesting copper IUD device insertion
排除标准
- •parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
研究组 & 干预措施
Isosorbide Mononitrate
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion
干预措施: Isosorbide mononitrate (Drug)
placebo
one tablet of placebo vaginally 3 hours prior to copper IUD insertion
干预措施: placebo (Drug)
结局指标
主要结局
pain during IUD insertion
时间窗: 5 minutes
intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' to the worst possible pain imaginable.
次要结局
- duration of IUD insertion(5 minutes)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University