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

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Device: IUD

• Registration Number: NCT02595125
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Study Start: 2016-02-24
• Primary Completion: 2017-07-12
• Study Completion: 2017-07-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct technique	IUD	Intrauterine device (IUD) insertion by the direct technique
Conventional technique	IUD	Intrauterine device (IUD) insertion by the conventional technique

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of analgesic intake	up to 7 days post-insertion
Number of expulsion of IUD	up to 7 days
Pain measured by Verbal Numeric Scale	day 7	Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)
Number of vagal discomfort	intraoperative
Number of IUD-fond uterine distance >2 cm	intraoperative
Number of emergency department visit for a IUD complication	up to 7 days
Number of failure laying direct technique	intraoperative
Number of expulsion of the IUD	intraoperative

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France