Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
研究概览
简要总结
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.
详细描述
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.
Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)
- •Ages 18-45
- •Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette
排除标准
- •Pregnancy occurring less than 6 weeks from time of presentation
- •History of prior intrauterine device placement
- •History of Mullerian tract anomalies
- •History of uterine surgery
- •Allergy or intolerance to misoprostol or other prostaglandin
- •Pelvic inflammatory disease (current or within the past 3 months)
- •Sexually transmitted diseases (current)
- •Puerperal or postabortion sepsis (current or within the past 3 months)
- •Purulent cervicitis (current)
- •Undiagnosed abnormal vaginal bleeding
- •Malignancy of the genital tract
- •Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion
- •Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)
研究组 & 干预措施
Misoprostol
Cervical preparation with misoprostol prior to intrauterine device insertion
干预措施: Misoprostol (Drug)
Placebo
Cervical preparation with placebo prior to intrauterine device insertion
干预措施: Magnesium Oxide (Dietary Supplement)
结局指标
主要结局
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
时间窗: Time of IUD insertion
Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).
次要结局
- Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).(At time of IUD insertion)
研究者
Alison Edelman
MD MPH
Oregon Health and Science University