Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe
试验速览
- 阶段
- 不适用
- 入组人数
- 158
- 试验地点
- 19
- 主要终点
- Pain level during the insertion of IUD or IUS
研究概览
简要总结
The so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose.
It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in these two methods of placement and also to confirm that there is no more malposition with the direct method.
详细描述
The classic method uses: a Pozzi for pulling the uterus to horizontalize it and a hysterometer to visualize the axis of the uterus and to measure the distance between the external orifice of the cervix and the uterine fundus in order to deploy the IUD / IUS.
In the so-called direct technique, the operator does not measure the depth of the uterus thanks to a hysterometer and does not draw the cervix with a Pozzi forceps, the IUD / IUS is deployed as soon as the orifice passes. inside the cervix and the inserter tube does not enter the uterine cavity. With this method the Pozzi forceps is only used as a second line, especially in case of a fleeing neck.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The study population will concern all women aged 18 to 50 who want IUD or SIU contraception regardless of whether they are nulliparous, primiparous or pluriparous, whether or not they have had an IUD or IUS.
- •Having signed informed consent.
- •Being affiliated to a social security scheme (excluding AME)
排除标准
- •Can not express their consent
- •Not mastering French
- •With a contraindication to the chosen IUD or IUS.
- •Having had local anesthesia of the cervix (in case of Voluntary Interruption of Pregnancy on the day of insertion)
- •Having received analgesic treatment within four hours
- •Patient without social security
- •No consent of the patient
- •Minor patient
结局指标
主要结局
Pain level during the insertion of IUD or IUS
时间窗: during the procedure of IUD/IUS insertion
Evaluation endpoint is pain felt by the patient during insertion of the IUD or IUS by a 0-100 mm standard visual analog scale (VAS)
次要结局
- IUD or SIU localization(Ultrasound control performed six to ten weeks after the pose.)