A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale
研究概览
简要总结
The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.
详细描述
IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous, no prior pregnancy beyond 14 week
- •Over 18 years of age
- •Negative pregnancy test
排除标准
- •current pregnancy or pregnancy within 6 weeks
- •current cervicitis or PID (active or within 3 months)
- •undiagnosed abnormal uterine bleeding
- •allergy to copper/ Wilson's disease (for Paragard)
- •cervical or uterine cancer
- •uterine anomaly altering uterine cavity
研究组 & 干预措施
misoprostol
400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion
干预措施: Misoprostol (Drug)
Placebo
Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale
时间窗: after IUD insertion
次要结局
- Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia(during IUD insertion)
- Side effects of medications(prior to IUD insertion)
- Provider perceived ease of insertion on a 100 mm visual analogue scale(after IUD insertion)
- Acceptability of wait time prior to IUD placement(1 week after IUD insertion)
- Procedure complications(Up to 1 month after IUD placement)
- Acceptability of total IUD placement process, would you recommend this to a friend?(1 week and 1 month after IUD insertion)
研究者
Pam Lotke
Principal Investigator
University of Arizona