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

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: IUD

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Conventional technique; Intrauterine device (IUD) insertion by the conventional technique	Device: IUD; copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique
Experimental: Direct technique; Intrauterine device (IUD) insertion by the direct technique	Device: IUD; copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of failure laying direct technique		intraoperative
Number of vagal discomfort		intraoperative
Number of expulsion of the IUD		intraoperative
Number of IUD-fond uterine distance >2 cm		intraoperative
Number of expulsion of IUD		up to 7 days
Number of emergency department visit for a IUD complication		up to 7 days
Number of analgesic intake		up to 7 days post-insertion
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2016
• Primary Completion (Actual): July 12, 2017
• Study Completion (Actual): July 19, 2017

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: intrauterine device; contraceptive method; direct technique; torpedo technique; verbal numeric scale
• Other Study ID Numbers: 1508153; 2015-A01966-43 (Other Identifier: ANSM)

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