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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473717
Recruitment Status : Unknown
Verified February 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
IUD Insertion Device: classic method Device: direct method Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe
Estimated Study Start Date : March 30, 2018
Estimated Primary Completion Date : October 15, 2018
Estimated Study Completion Date : March 15, 2019

Arm Intervention/treatment
Active Comparator: classic method group
IUD/IUS insertion will be done using the conventional method
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.

Active Comparator: direct method group
IUD/IUS insertion will be done using the direct method
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. IUD or SIU localization [ Time Frame: Ultrasound control performed six to ten weeks after the pose. ]
    localization of IUD/IUS will be controlled by a pelvic ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   the study concerns women who want IUD or SIU contraception
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473717


Contacts
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Contact: Catherine Soulat, doctor +33668343890 catsoulat@wanadoo.fr
Contact: Charlotte Rambault +33619430824 charlotte.rambault@laposte.net

Locations
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France
CIVG Hôpital Avicenne
Bobigny, France, 93000
Contact: Maud Gelly    01 48 95 57 71    maud.gelly@aphp.fr   
Principal Investigator: Maud Gelly, Dr         
CIVG Hôpital Louis Mourier
Colombes, France, 92700
Contact: Catherine Soulat    01 47 60 63 51    catsoulat@wanadoo.fr   
Sub-Investigator: Françoise Bâcle         
Sub-Investigator: Cécile Cousyn         
Sub-Investigator: Mathilde Audlauer         
Principal Investigator: Catherine Soulat         
Liberal Cabinet Midwife
Courbevoie, France, 92400
Contact: Manon Forthoffer    06 33 22 48 39    manon.sagefemme@gmail.com   
Principal Investigator: Manon Forthoffer         
Liberal Cabinet Midwife
Fontenay-sous-Bois, France, 94120
Contact: Anne Seuront    06 76 78 35 60    aseurontschneider@free.fr   
Principal Investigator: Anne Seuront         
Centre de Santé Gatineau Saillant
Gennevilliers, France, 92230
CPEF
Gennevilliers, France, 92230
Contact: Anna Christidis, Dr    01 40 85 66 83    annachristidis@gmail.com   
Principal Investigator: anna Christidis, Dr         
Medical Office Gynecology
Paris, France, 75011
Contact: Catherine Soulat, Dr    01 43 38 00 40    catsoulat@wanadoo.fr   
Principal Investigator: Catherine Soulat, Dr         
Hôpital Trousseau
Paris, France, 75012
ACSBE-La place santé
Saint-Denis, France, 93200
Contact: Cécile Cousyn, Dr    01 48 09 09 17    cecile.cousyn@gmail.com   
Principal Investigator: Cécile Cousyn, Dr         
Sub-Investigator: Mathilde Audlauer, Dr         
Medical Practice General Practice
Villeneuve-la-Garenne, France, 92390
Contact: Françoise Bâcle, Dr    01 40 85 05 02    fbacle@laposte.net   
Principal Investigator: Françoise Bâcle, dr         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot
Investigators
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Principal Investigator: Catherine Soulat CIVG Hôpital Louis Mourier, AP-HP

Additional Information:
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03473717    
Other Study ID Numbers: HAO 180104
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
pain
Intrauterine device (IUD)
Intrauterine system (IUS)
Patient-Reported Outcome