NCT03790371已完成3 期
Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion Following Previous Insertion Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the success rate for IUD insertion.
研究概览
简要总结
the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •One previous failed attempt of IUD insertion.
排除标准
- •Uterine fibroid distorting the cavity.
- •Anatomical uterine abnormality with distortion of the cavity
- •Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months.
- •Current purulent cervicitis (chlamydia or gonorrhea).
- •Immediately after septic abortion.
- •Uterus size less than 6 cm and more than 9 cm.
研究组 & 干预措施
misoprostol group
Active Comparator
misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion
干预措施: Misoprostol (Drug)
placebo
Placebo Comparator
while the control group received a placebo tablet in the same regimen as the study group.
干预措施: Placebos (Drug)
结局指标
主要结局
the success rate for IUD insertion.
时间窗: four hours after misoprostol dose
the success of IUD insertion after previous attempt failure
次要结局
未报告次要终点
研究者
Radwa Rasheedy Ali
Principal Investigator
Ain Shams University
研究点 (1)
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