Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- degree of pain during IUD insertion
研究概览
简要总结
A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females desiring contraception with the use of IUD
- •Females with history of previous vaginal delivery
排除标准
- •Are pregnant or think they may be pregnant
- •Septic pregnancy or abortion
- •Have unexplained abnormal vaginal bleeding
- •Have untreated cervical cancer
- •Have malignant gestational trophoblastic disease
- •Have uterine cancer
- •Have uterine abnormalities
- •Have or may have had a pelvic infection within the past three months
- •Have or may have any sexually transmitted disease
- •Have pelvic tuberculosis
- •Are postpartum between 48 hours and 4 weeks
- •Have benign gestational trophoblastic disease
结局指标
主要结局
degree of pain during IUD insertion
时间窗: 4 months
Pain will be assessed by the use of visual analog scale (VAS).
次要结局
未报告次要终点
研究者
Dina Mohamed Refaat Dakhly
Lecturer of Obstetrics and Gynecology
Woman's Health University Hospital, Egypt