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

Contraception Clinical Trial

— DIRECTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595125
• Other study ID #: 1508153
• Secondary ID: 2015-A01966-43
• Status: Completed
• Phase: N/A
• First received: November 2, 2015
• Last updated: January 26, 2018
• Start date: February 24, 2016
• Est. completion date: July 19, 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 19, 2017
• Est. primary completion date: July 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• IUD
copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured by Verbal Numeric Scale	Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)	intraoperative
Secondary	Number of failure laying direct technique		intraoperative
Secondary	Number of vagal discomfort		intraoperative
Secondary	Number of expulsion of the IUD		intraoperative
Secondary	Number of IUD-fond uterine distance >2 cm		intraoperative
Secondary	Number of expulsion of IUD		up to 7 days
Secondary	Number of emergency department visit for a IUD complication		up to 7 days
Secondary	Number of analgesic intake		up to 7 days post-insertion
Secondary	Pain measured by Verbal Numeric Scale	Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)	day 1
Secondary	Pain measured by Verbal Numeric Scale	Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)	day 7