Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Overweight and Obese Women :a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The difference in visual analog scale pain scores during intrauterine device insertion
研究概览
简要总结
To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese women
详细描述
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
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)
盲法说明
double blind randomized controlled trial
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
- •multi parous women requesting copper IUD insertion
- •body mass index more than 25
排除标准
- •pregnancy,
- •null parous women,
- •contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
- •untreated active cervicitis or vaginitis,
- •undiagnosed abnormal uterine bleeding
研究组 & 干预措施
misoprostol
2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
干预措施: misoprostol (Drug)
placebo
Placebo Comparator: placebo 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion.
干预措施: placebo (Drug)
dinoprostone
2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
干预措施: dinoprostol (Drug)
结局指标
主要结局
The difference in visual analog scale pain scores during intrauterine device insertion
时间窗: 10 minuts
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
次要结局
- Intensity of pain: visual analogue scale(30 minutes after the procedure)
- the ease of IUD insertion(10 minutes)
- women's satisfaction level: score(10 minutes)
- the difference in visual analog scale pain scores during tenaculum application(10 minutes)
研究者
hany farouk
A Professor
Aswan University Hospital