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

NCT02595125 | Completed

• 2 other identifiers: 15081532015-A01966-43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

intrauterine device; contraceptive method; direct technique; torpedo technique; verbal numeric scale

Outcome Measures

Primary Outcomes (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)

  intraoperative

Secondary Outcomes (9)

• 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

Study Arms (2)

Conventional technique

SHAM COMPARATOR

Intrauterine device (IUD) insertion by the conventional technique

Device: IUD

Direct technique

EXPERIMENTAL

Intrauterine device (IUD) insertion by the direct technique

Device: IUD

Interventions

IUD DEVICE

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

Conventional technique; Direct technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• Céline Chauleur, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: February 24, 2016
• Primary Completion: July 12, 2017
• Study Completion: July 19, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)