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

March 21, 2018 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bobigny, France, 93000
        • CIVG Hôpital Avicenne
        • Contact:
        • Principal Investigator:
          • Maud Gelly, Dr
      • Colombes, France, 92700
        • CIVG hôpital Louis Mourier
        • Contact:
        • Sub-Investigator:
          • Françoise Bâcle
        • Sub-Investigator:
          • Cécile Cousyn
        • Sub-Investigator:
          • Mathilde Audlauer
        • Principal Investigator:
          • Catherine Soulat
      • Courbevoie, France, 92400
        • Liberal Cabinet Midwife
        • Contact:
        • Principal Investigator:
          • Manon Forthoffer
      • Fontenay-sous-Bois, France, 94120
        • Liberal Cabinet Midwife
        • Contact:
        • Principal Investigator:
          • Anne Seuront
      • Gennevilliers, France, 92230
        • Centre de Santé Gatineau Saillant
      • Gennevilliers, France, 92230
        • CPEF
        • Contact:
        • Principal Investigator:
          • anna Christidis, Dr
      • Paris, France, 75011
        • Medical Office Gynecology
        • Contact:
        • Principal Investigator:
          • Catherine Soulat, Dr
      • Paris, France, 75012
        • Hopital Trousseau
      • Saint-Denis, France, 93200
        • ACSBE-La place santé
        • Contact:
        • Principal Investigator:
          • Cécile Cousyn, Dr
        • Sub-Investigator:
          • Mathilde Audlauer, Dr
      • Villeneuve-la-Garenne, France, 92390
        • Medical Practice General Practice
        • Contact:
        • Principal Investigator:
          • Françoise Bâcle, dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
during the procedure of IUD/IUS insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Ultrasound control performed six to ten weeks after the pose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot

Investigators

  • Principal Investigator: Catherine Soulat, CIVG Hôpital Louis Mourier, AP-HP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 30, 2018

Primary Completion (Anticipated)

October 15, 2018

Study Completion (Anticipated)

March 15, 2019

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HAO 180104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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