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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 (EPODIU)

R

Raincy Montfermeil Hospital Group

Status

Unknown

Conditions

Acceptance Processes

Treatments

Other: Group B who will answer a questionnaire after having the information about the intrauterine devices
Other: Group A, who will complete a questionnaire before receiving information about intrauterine devices

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT05317715
GHT-GHI LRM-20220118

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

without device information
Other group
Description:
this group of patients will complete a questionnaire before receiving information on contraceptive intrauterine devices (copper or hormonal)
Treatment:
Other: Group A, who will complete a questionnaire before receiving information about intrauterine devices
with device information
Other group
Description:
This group of patients will receive information about contraceptive intrauterine devices (copper or hormonal) before completing a questionnaire
Treatment:
Other: Group B who will answer a questionnaire after having the information about the intrauterine devices

Trial contacts and locations

1

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Central trial contact

Jean GUILLEMINOT, MD

Data sourced from clinicaltrials.gov

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