Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Reducing Pain During Levonorgestrel IUD Insertion in Women Delivered Only by Cesarean Deliveries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- pain during LNG-IUD insertion
研究概览
简要总结
the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries
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
- •women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion
排除标准
- •women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs
研究组 & 干预措施
vaginal misoprostol
vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus vaginal inert placebo cream at the time of IUD insertion
干预措施: vaginal misoprostol (Drug)
lidocaine prilocaine cream
Lidocaine-prilocaine anesthetic cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo will be given 3 hours before LNG-IUD insertion
干预措施: Lidocaine-Prilocaine Topical cream (Drug)
placebo
inert vaginal placebo cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours before LNG-IUD insertion
干预措施: placebo (Drug)
结局指标
主要结局
pain during LNG-IUD insertion
时间窗: 5 minutes
pain during LNG-IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst imaginable pain
次要结局
- duration of insertion(5 minutes)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University