Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery:a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 主要终点
- The difference in 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 women delivered only by cesarean section.
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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 delivered only by elective cesarean section and not received analgesics in the last 24 hours
排除标准
- •contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.
研究组 & 干预措施
dinoprostone
1 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: Dinoprostone 3 mg (Drug)
misoprostol
1 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 200Mcg Tab (Drug)
placebo
one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.
干预措施: placebo (Drug)
结局指标
主要结局
The difference in pain scores during intrauterine device insertion
时间窗: 10 minutes
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
次要结局
未报告次要终点
研究者
Ahmed Samy aly ashour
assistant professor
Cairo University