Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- IUD Insertion
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 158
- Locations
- 9
- Primary Endpoint
- Pain level during the insertion of IUD or IUS
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Pain level during the insertion of IUD or IUS
Time Frame: 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)
Secondary Outcomes
- IUD or SIU localization(Ultrasound control performed six to ten weeks after the pose.)