Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance Versus the Standard Technique for IUD Insertion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .
详细描述
The intrauterine device (IUD) is an effective method of contraception. Pain experienced during IUD insertion is one of the main causes that limits its widespread use.
Pain during IUD insertion is caused by insertion of cusco vaginal speculum, sounding the uterus, application of vulsellum to grasp the cervix, the passage of the inserter tube through the cervical canal and uterine cavity..
In order to minimize the pain associated with IUD insertion , several studies reported that the use of ultrasound to guide the insertion of IUD into uterine cavity was associated with less pain and more accurate placement of IUD, other studies reported that filling the bladder during IUD insertion minimized the pain associated with IUD insertion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women requesting IUD insertion
排除标准
- •Active pelvic infection
- •Viable intrauterine pregnancy
- •Uterine anomalies
- •Uterine fibroid
- •Wilson disease
研究组 & 干预措施
Vulsellum group
The patients are asked to empty the bladder before IUD insertion. The vulsellum is applied on the cervix, sounding of the uterus is done and the IUD is inserted according to the standard technique of IUD insertion.
Pain intensity is assessed after the procedure using a visual analogue scale.
干预措施: Vulsellum group (Procedure)
Ultrasound group
During the two hour period before IUD insertion, the patients are asked to drink about one liter of water and to avoid micturition.
Abdominal ultrasound is used to obtain a sagittal view of the uterus and the IUD is introduced into the uterine cavity under ultrasound guidance.
The vulsellum and uterine sound are not used during IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale.
干预措施: Ultrasound group (Procedure)
结局指标
主要结局
Intensity of pain
时间窗: Immediately after the procedure
Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)
次要结局
- Success of IUD insertion(Immediately after the procedure)