Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method (EPODIU)

"Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method"

Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns.

Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010.

In practice, in France, use of the IUD is still "reserved" for older women or those who have already had children, despite medical recommendations.

In this study the investigator will investigate whether clear information about the mode of action and insertion/withdrawal of IUDs would dispel these misconceptions of patients.

Study Overview

• Status: Recruiting
• Conditions: Acceptance Processes
• Intervention / Treatment: Other: Group A, who will complete a questionnaire before receiving information about intrauterine devices; Other: Group B who will answer a questionnaire after having the information about the intrauterine devices

Detailed Description

Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns.

Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010.

In practice in France, the use of IUDs is still "reserved" for older women or those who have already had children, despite medical recommendations. Indeed, there is a certain feeling of mistrust towards the IUD as a contraceptive method. Sometimes the patient's reasons for refusal were unclear or misconceptions and prejudices prevailed.

Various research studies and theses have identified the various obstacles to the use of the IUD as a contraceptive. Today it would be interesting to evaluate whether a short presentation of the IUD during a consultation would lead to a better acceptance of women to use it as a possible contraceptive method.

In this study the investigators will investigate whether clear information about the mode of action and insertion/removal of IUDs would dispel these misconceptions of patients.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Guilleminot, MD; Phone Number: +33 01 41 70 81 19; Email: jean.guilleminot@ght-gpne.fr

Study Locations

• France
  • Montfermeil, France, 93370
    • Recruiting
    • Le Raincy Montfermeil hospital
    • Contact: Jean Guilleminot, MD; Phone Number: +33 01 41 70 81 19; Email: jean.guilleminot@ght-gpne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Any woman aged 18 years and over who comes to a family planning centre
• Having expressed her free and informed written consent
• Affiliated to a social security scheme

Exclusion Criteria:

• Women under 18 years of age
• Woman with an IUD
• Woman who has had an IUD before
• Woman whose reason for consultation of the day is the insertion of an IUD
• Menopausal woman
• Woman who is infertile for any reason
• Illiterate woman or woman who does not read French
• Refusal to participate in the protocol
• Incapable of age.
• Pregnant or breastfeeding women
• Vulnerable persons and protected persons as provided for in the Public Health Code Public Health Code (articles L. 1121-5 to L.1121-8 and L.1122-1-2).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: without device information; this group of patients will complete a questionnaire before receiving information on contraceptive intrauterine devices (copper or hormonal)	Other: Group A, who will complete a questionnaire before receiving information about intrauterine devices; Group A will complete a questionnaire before receiving information about intrauterine devices and a demonstration of insertion/removal on a plastic dummy uterus.
OTHER: with device information; This group of patients will receive information about contraceptive intrauterine devices (copper or hormonal) before completing a questionnaire	Other: Group B who will answer a questionnaire after having the information about the intrauterine devices; Group B will complete a questionnaire after receiving information about IUDs and a demonstration of insertion/removal on a plastic dummy uterus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acceptance of the IUD as a possible contraceptive method	measuring the acceptance rate of the intrauterine device as a potential contraceptive method	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basic knowledge of intrauterine devices	verification of Basic knowledge of intrauterine devices	day 1

Collaborators and Investigators

• Sponsor: Raincy Montfermeil Hospital Group
• Investigators: Principal Investigator: Jean GUILLEMINOT, MD, Le Raincy Montfermeil hospital

Publications and helpful links

Helpful Links

• The delivery of information by the health professional to the patient about contraception: a descriptive cross-sectional study

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2022
• Primary Completion (ANTICIPATED): August 14, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (ACTUAL): April 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Contraception; Intrauterine devices
• Other Study ID Numbers: GHT-GHI LRM-20220118

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