A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
详细描述
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. 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 use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.
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
- •18 years old or older
- •negative pregnancy test
- •no prior pregnancies beyond 14 6/7 weeks
- •no PID in last 3 months
- •no current cervicitis
- •be willing to follow-up in 1-2 months for an IUD string check.
排除标准
- •active cervical infection
- •current pregnancy
- •prior pregnancy beyond 14 weeks gestation
- •known uterine anomaly
- •fibroid uterus distorting uterine cavity
- •copper allergy/Wilson's disease (for Paragard)
- •undiagnosed abnormal uterine bleeding
- •cervical or uterine cancer.
研究组 & 干预措施
Misoprostol
Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
干预措施: Misoprostol (Drug)
Placebo
Pills which are identical to the study drug in appearance, taste, and smell.
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 (VAS)
时间窗: Immediately post IUD insertion
VAS (anchors: 0 = extremely easy, 100 mm= impossible)
次要结局
- Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)(prior to insertion, immediately after insertion, and prior to clinic discharge)
研究者
David Turok
Assistant Professor
University of Utah