NCT03473717

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• IUD Insertion

Interventions

Type	Name	Description
DEVICE	classic method	* 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.
DEVICE	direct method	* 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

Timeline

• Start date: 2018-03-30
• Primary completion: 2018-10-15
• Completion: 2019-03-15
• First posted: 2018-03-22
• Last updated: 2018-03-22

Locations

10 sites across 1 country: France