Evaluation of the Impact of an Oral and Practical Present... | NCT05317715

Studies
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

NCT05317715

Sponsor

Raincy Montfermeil Hospital Group

Status

Unknown status

Last Update Posted

May 2, 2022Actual

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Acceptance Processes

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2022Actual

Primary Completion Date

Aug 14, 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Mar 21, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Apr 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2022

Last Update Posted Date

May 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
without device information	Other	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
with device information	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group A, who will complete a questionnaire before receiving information about intrauterine devices	Other	Group A will complete a questionnaire before receiving information about intrauterine devices and a demonstration of insertion/removal on a plastic dummy uterus.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of acceptance of the IUD as a possible contraceptive method	measuring the acceptance rate of the intrauterine device as a potential contraceptive method	day 1

Secondary Outcomes

Measure	Description	Time Frame
Basic knowledge of intrauterine devices	verification of Basic knowledge of intrauterine devices	day 1

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean GUILLEMINOT, MD	Contact	01 41 70 81 19	+33	jean.guilleminot@ght-gpne.fr

Overall Officials

Name	Affiliation	Role
Jean GUILLEMINOT, MD	Le Raincy Montfermeil hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Le Raincy Montfermeil hospital	Recruiting	Montfermeil		93370	France

References Module

Citations

Not provided