NCT02393495已完成不适用
A Further Step Towards Painless Intrauterine Device Insertion, a Randomized Control Trial
Woman's Health University Hospital, Egypt2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Assessment of degree of pain during IUD insertion
研究概览
简要总结
Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in addition, it reduces the incidence of malposition of IUD as well as the risk of complications.
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
- None
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
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
- •Have ovarian cancer
- •Have AIDS (unless clinically well on anti-retroviral therapy)
结局指标
主要结局
Assessment of degree of pain during IUD insertion
时间窗: 6 months
Pain will be assessed by the use of visual analog scale, Pain rating scale
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
研究点 (2)
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