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ClinicalTrials.gov ID

NCT03473717

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

158Estimated

Last Update Posted

Mar 22, 2018Actual

Start Date

Mar 30, 2018Estimated

Primary Completion Date

Oct 15, 2018Estimated

Completion Date

Mar 15, 2019Estimated

Official Title

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

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.

• IUD Insertion

• classic method
• direct method

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

URC-ECO Clinical trial unit on health Economics, Hotel-Dieu HospitalUNKNOWN

EA 7334 Patient-Centered Outcomes Research, University Paris-DiderotUNKNOWN

catsoulat@wanadoo.fr01 47 60 63 51

manon.sagefemme@gmail.com06 33 22 48 39

aseurontschneider@free.fr06 76 78 35 60

annachristidis@gmail.com01 40 85 66 83

catsoulat@wanadoo.fr01 43 38 00 40

cecile.cousyn@gmail.com01 48 09 09 17