Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe

Conditions
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IUD Insertion

Intervention / Treatment
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* Device: classic method
* Device: direct method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: classic method group<br>IUD/IUS insertion will be done using the conventional method | Device: classic method<br>* Put the Pozzi forceps to draw the uterus by the cervix to horizontalize it and align uterine cavity in the direct axis of cervix. Insert the hysterometer to measure the uterus depth. Locate the uterine depth on the inserter tube.<br>|
| Active Comparator: direct method group<br>IUD/IUS insertion will be done using the direct method | Device: direct method<br>* Place the ring on the inserter tube 3 to 4 cm from the end as a marker. Insert the tube into the cervix until you feel the passage of the internal orifice of the cervix or until the ring is in contact with the external orifice of the cervix, the tube does not enter the uterine cavity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level during the insertion of IUD or IUS | 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) | during the procedure of IUD/IUS insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD or SIU localization | localization of IUD/IUS will be controlled by a pelvic ultrasound | Ultrasound control performed six to ten weeks after the pose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Intrauterine device (IUD), Intrauterine system (IUS), Patient-Reported Outcome