Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 9, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date March 22, 2018
Estimated Study Start Date  ICMJE March 30, 2018
Estimated Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method
Official Title  ICMJE 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE IUD Insertion
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: classic method group
    IUD/IUS insertion will be done using the conventional method
    Intervention: Device: classic method
  • Active Comparator: direct method group
    IUD/IUS insertion will be done using the direct method
    Intervention: Device: direct method
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
158
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 15, 2019
Estimated Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: the study concerns women who want IUD or SIU contraception
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03473717
Other Study ID Numbers  ICMJE HAO 180104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
  • EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot
Investigators  ICMJE
Principal Investigator: Catherine Soulat CIVG Hôpital Louis Mourier, AP-HP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP