Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Women
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- pain during IUD insertion: visual analog scale
研究概览
简要总结
the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •multiparous women requesting IUD insetion
排除标准
- •active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol
研究组 & 干预措施
vaginal dinoprostone
vaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion
干预措施: vaginal dinoprostone (Drug)
vaginal misoprostol
vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion
干预措施: vaginal misoprostol (Drug)
placebo
two tablets of placebo similar in shape ,color, odor to the study drugs
干预措施: placebo (Drug)
结局指标
主要结局
pain during IUD insertion: visual analog scale
时间窗: 2 minutes
pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
次要结局
- duration of IUD insertion(5 minutes)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University