Acceptance ProcessesEPODIUNCT05317715
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
A study testing Group A, who will complete a questionnaire before receiving information about intrauterine devices and Group B who will answer a questionnaire after having the information about the intrauterine devices in people with Acceptance Processes, run by Raincy Montfermeil Hospital Group at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Acceptance Processes
- What is being tested?
- Group A, who will complete a questionnaire before receiving information about intrauterine devices and Group B who will answer a questionnaire after having the information about the intrauterine devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Le Raincy Montfermeil hospital
Montfermeil, 93370
Jean Guilleminot, MD, 01 41 70 81 19 ext. +33, jean.guilleminot@ght-gpne.fr
About this study
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"
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.
Read the 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.
- Conditions
- Acceptance Processes
- Being tested
- Group A, who will complete a questionnaire before receiving information about intrauterine devices, Group B who will answer a questionnaire after having the information about the intrauterine devices
- Keywords
- Contraception, Intrauterine devices
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A, who will complete a questionnaire before receiving information about intrauterine devicesOther
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 devicesOther
Group B will complete a questionnaire after receiving information about IUDs and a demonstration of insertion/removal on a plastic dummy uterus.
| Study group | Role | What they receive |
|---|---|---|
| without device information | Other | this group of patients will complete a questionnaire before receiving information on contraceptive intrauterine devices (copper or hormonal) Receives: Other: Group A, who will complete a questionnaire before receiving information about intrauterine devices |
| with device information | Other | This group of patients will receive information about contraceptive intrauterine devices (copper or hormonal) before completing a questionnaire Receives: Other: Group B who will answer a questionnaire after having the information about the intrauterine devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acceptance of the IUD as a possible contraceptive method
measuring the acceptance rate of the intrauterine device as a potential contraceptive method
Measured: day 1
Secondary outcomes (1)
Basic knowledge of intrauterine devices
verification of Basic knowledge of intrauterine devices
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start14 Apr 2022
- Primary completion14 Aug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance ProcessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raincy Montfermeil Hospital Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean GUILLEMINOT, MD, Principal investigator, Le Raincy Montfermeil hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317715
- Sponsor's protocol ID
- GHT-GHI LRM-20220118
- Acronym
- EPODIU
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT05317715
- Acronym / sponsor ID
- EPODIU / GHT-GHI LRM-20220118
- Conditions
- Acceptance Processes
- Keywords
- Contraception, Intrauterine devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Raincy Montfermeil Hospital GroupResearch network
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 14 Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| without device information | Other | Other: Group A, who will complete a questionnaire before receiving information about intrauterine devicesthis group of patients will complete a questionnaire before receiving information on contraceptive intrauterine devices (copper or hormonal) |
| with device information | Other | Other: Group B who will answer a questionnaire after having the information about the intrauterine devicesThis group of patients will receive information about contraceptive intrauterine devices (copper or hormonal) before completing a questionnaire |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A, who will complete a questionnaire before receiving information about intrauterine devicesGroup A will complete a questionnaire before receiving information about intrauterine devices and a demonstration of insertion/removal on a plastic dummy uterus. | Other | without device information |
| Group B who will answer a questionnaire after having the information about the intrauterine devicesGroup B will complete a questionnaire after receiving information about IUDs and a demonstration of insertion/removal on a plastic dummy uterus. | Other | with device information |
Primary outcome
Rate of acceptance of the IUD as a possible contraceptive method
Time frame: day 1
measuring the acceptance rate of the intrauterine device as a potential contraceptive method
1 secondary outcome
Basic knowledge of intrauterine devices
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- The delivery of information by the health professional to the patient about contraception: a descriptive cross-sectional studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean GUILLEMINOT, MD principal investigator
Le Raincy Montfermeil hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A, who will complete a questionnaire before receiving information about intrauterine devices and Group B who will answer a questionnaire after having the information about the intrauterine devices in people with Acceptance Processes, run by Raincy Montfermeil Hospital Group at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean GUILLEMINOT, MD (01 41 70 81 19 ext. +33, jean.guilleminot@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acceptance of the IUD as a possible contraceptive method (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.