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Completed

NCT Number: NCT02595125

Study Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique

Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any major patient and consultant for IUD insertion : hormonal or copper
  • Signing of the information and consent form by the patient or, if under supervision by parents or guardian.
  • Patient affiliated with or entitled to a social security scheme
  • No contraindication for IUD insertion

Exclusion criteria

  • Patient consultant for IUD insertion to side arms
  • Contraindications for installation.
  • Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent
  • Refusal to sign the consent.

Treatment and study plan

IUD

Device

copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique

Primary outcomes

  1. Pain measured by Verbal Numeric Scale

    Time frame: intraoperative

    Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)

Secondary outcomes

  1. Number of failure laying direct technique

    Time frame: intraoperative

  2. Number of vagal discomfort

    Time frame: intraoperative

  3. Number of expulsion of the IUD

    Time frame: intraoperative

  4. Number of IUD-fond uterine distance >2 cm

    Time frame: intraoperative

  5. Number of expulsion of IUD

    Time frame: up to 7 days

  6. Number of emergency department visit for a IUD complication

    Time frame: up to 7 days

  7. Number of analgesic intake

    Time frame: up to 7 days post-insertion

  8. Pain measured by Verbal Numeric Scale

    Time frame: day 1

    Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)

  9. Pain measured by Verbal Numeric Scale

    Time frame: day 7

    Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study

Acronym: DIRECTE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2015
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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