A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale
研究概览
简要总结
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
详细描述
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •negative pregnancy test
- •no prior pregnancy beyond 19 6/7 weeks
- •no pelvic inflammatory disease in last 3 months
- •no current cervicitis
- •willing to follow up in 1-2 months
排除标准
- •active cervical infection
- •current pregnancy
- •prior pregnancy beyond 19 6/7 weeks
- •uterine anomaly
- •fibroid uterus distorting uterine cavity
- •copper allergy or wilson's disease for ParaGard
- •undiagnosed abnormal uterine bleeding
- •cervical or uterine cancer
- •sepsis associated with the most recent pregnancy
- •current breast cancer for levonogestrel IUD
- •inflammatory bowel disease
- •allergy to misoprostol
研究组 & 干预措施
misoprostol
Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
干预措施: Misoprostol (Drug)
placebo
Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
干预措施: Placebo (Drug)
结局指标
主要结局
Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale
时间窗: assessed immediately post IUD insertion
The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
次要结局
- Patient Perceived Pain on a 100 Point Visual Analogue Scale(immediately after insertion)
- The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD(assessed immediately after IUD insertion)
- Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women(assessed immediately following insertion)
- Time for Insertion Procedure(assessed immediately after IUD insertion)
- Acceptability of Discomfort Associated With Insertion(assessed at one week after insertion and at one month after insertion)
- Need for Additional Pain Medications After Insertion of the IUD(assessed one week after insertion)
研究者
Eva Lathrop, MD
Assistant Professor
Emory University