Clinical trial NCT05317715: 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
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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acceptance Processes
Keywords: Contraception
Intrauterine devices
Lead sponsor: Raincy Montfermeil Hospital Group
Sponsor class: NETWORK
First posted: 2022-04-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of acceptance of the IUD as a possible contraceptive method
timeFrame: day 1
Secondary outcomes:
measure: Basic knowledge of intrauterine devices
timeFrame: day 1
Other outcomes:
Locations:
city: Montfermeil
country: France
facility: Le Raincy Montfermeil hospital
Study officials:
affiliation: Le Raincy Montfermeil hospital
name: Jean GUILLEMINOT, MD
role: PRINCIPAL_INVESTIGATOR
References: