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

Acceptance Processes Clinical Trial

— EPODIU  

Official title:

"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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317715
• Other study ID #: GHT-GHI LRM-20220118
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: October 2022

Study information

• Verified date: March 2022
• Source: Raincy Montfermeil Hospital Group
• Contact: Jean GUILLEMINOT, MD
• Phone: 01 41 70 81 19
• Email: jean.guilleminot[@]ght-gpne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2022
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acceptance Processes

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Le Raincy Montfermeil hospital	Montfermeil

Sponsors (1)

Lead Sponsor	Collaborator
Raincy Montfermeil Hospital Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Basic knowledge of intrauterine devices	verification of Basic knowledge of intrauterine devices	day 1

External Links

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