Benefits of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The difference in pain scores during intrauterine device insertion
研究概览
简要总结
To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.
详细描述
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind randomized controlled study
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device
排除标准
- •pregnancy and
- •contraindication or allergy to or contraindication to IUD insertion,
- •chronic pelvic pain,
- •pelvic inflammatory disease,
- •analgesic intake 24 hours prior to IUD insertion.
研究组 & 干预措施
INH
3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
干预措施: INH (Drug)
Placebo Comparator
3 tablet of placebo self-administered by the patient 12 hours before IUD insertion
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
The difference in pain scores during intrauterine device insertion
时间窗: 10 minutes
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
次要结局
- Provider ease of insertion(10 minutes)
- duration of IUD insertion(10 minutes)
研究者
hany farouk
A Professor
Aswan University Hospital