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

• Sponsor: Raincy Montfermeil Hospital Group (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05317715
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.6
• Patients Per Site Per Month: 28.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acceptance Processes	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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 questionnaireSingle-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
• Masking: None (Open Label)
• Primary Purpose: Other
• 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"
• Actual Study Start Date: Apr 14, 2022
• Anticipated Primary Completion Date: Aug 14, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Rate of acceptance of the IUD as a possible contraceptive method [day 1]

   measuring the acceptance rate of the intrauterine device as a potential contraceptive method

Secondary Outcome Measures

1. Basic knowledge of intrauterine devices [day 1]

   verification of Basic knowledge of intrauterine devices

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Le Raincy Montfermeil hospital	Montfermeil		France	93370

Sponsors and Collaborators

• Raincy Montfermeil Hospital Group

Investigators

• Principal Investigator: Jean GUILLEMINOT, MD, Le Raincy Montfermeil hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Raincy Montfermeil Hospital Group
• ClinicalTrials.gov Identifier: NCT05317715
• Other Study ID Numbers: GHT-GHI LRM-20220118
• First Posted: Apr 8, 2022
• Last Update Posted: May 2, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raincy Montfermeil Hospital Group: Contraception; Intrauterine devices

Study Results

No Results Posted as of May 2, 2022