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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05317715
Acronym
EPODIU
Enrollment
160
Registered
2022-04-08
Start date
2022-04-14
Completion date
2022-10-31
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptance Processes

Keywords

Contraception, Intrauterine devices

Brief 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.

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.

Interventions

OTHERGroup 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.

OTHERGroup 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.

Sponsors

Raincy Montfermeil Hospital Group
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single-centre, prospective, randomised, open-label study comparing a group of patients who had information and demonstration about IUDs prior to completing a questionnaire and a group of patients who did not have information and demonstration about IUDs prior to completing the questionnaire

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Rate of acceptance of the IUD as a possible contraceptive methodday 1measuring the acceptance rate of the intrauterine device as a potential contraceptive method

Secondary

MeasureTime frameDescription
Basic knowledge of intrauterine devicesday 1verification of Basic knowledge of intrauterine devices

Countries

France

Contacts

Primary ContactJean GUILLEMINOT, MD
jean.guilleminot@ght-gpne.fr01 41 70 81 19

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026