Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 210
- 主要终点
- pain during IUD insertion: visual analog scale
研究概览
简要总结
the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nulliparous women requesting copper IUD insertion
排除标准
- •multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
研究组 & 干预措施
vaginal dinoprostone
vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion.
干预措施: vaginal dinoprostone (Drug)
lidocaine prilocaine cream
Lidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion
干预措施: Lidocaine-prilocaine Cream (Drug)
placebo
inert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion
干预措施: placebo (Drug)
结局指标
主要结局
pain during IUD insertion: visual analog scale
时间窗: 5 minutes
pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable
次要结局
- duration of insertion(5 minutes)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University