Misoprostol Prior to Intrauterine Device Insertion in Non-menstruating Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The degree of pain perception during IUD insertion assessed by visual analogue scale
研究概览
简要总结
The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive method . In spite of that, the pain associated with IUD insertion can be a cause against its insertion. Many researches have been conducted aiming to decrease the degree of pain during IUD insertion; these studies included medical and also technical methods.
The physicians usually prefer to insert the IUD during women's menses because the women are very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness of IUD insertion is a very important issue that can increase women's satisfaction and decrease insertion pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years
- •Non-pregnant women
- •Women who will come when there are non-menstruating.
排除标准
- •Women received any analgesics or misoprostol in the 24 hours prior to insertion
- •Women with any contraindications for IUD insertion
- •Nulliparous women
- •Women refuse to participate.
- •Women have any contraindication of misoprostol.
研究组 & 干预措施
Misoprostol group
400 µg misoprostol vaginally ; these tablets will be introduced by the principal investigator, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position
干预措施: Misoprostol (Drug)
Misoprostol group
400 µg misoprostol vaginally ; these tablets will be introduced by the principal investigator, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position
干预措施: IUD (Device)
No misoprostol group
will not receive any pre-insertion medications.
干预措施: IUD (Device)
结局指标
主要结局
The degree of pain perception during IUD insertion assessed by visual analogue scale
时间窗: 5 minutes
The visual analogue scale scored from 0 to 10 degree, 0 degree means no pain while 10 degree means maximum pain
次要结局
- The ease of IUD insertion: will be measured by visual analogue like scale [from 0 to 10](5 minutes)
研究者
Mohammed Khairy Ali
Assistant professor
Assiut University