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 | Unknown

• 1 other identifier: GHT-GHI LRM-20220118
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Acceptance Processes

Keywords

Contraception; Intrauterine devices

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Basic knowledge of intrauterine devices

  day 1

Study Arms (2)

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

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.

without device information

Group B who will answer a questionnaire after having the information about the intrauterine devices OTHER

Group B will complete a questionnaire after receiving information about IUDs and a demonstration of insertion/removal on a plastic dummy uterus.

with device information

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Raincy Montfermeil Hospital Group: lead

Study Sites (1)

Le Raincy Montfermeil hospital

Montfermeil, 93370, France

RECRUITING

Related Links

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

MeSH Terms

Conditions

Behavior

Study Officials

• Jean GUILLEMINOT, MD

  Le Raincy Montfermeil hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean GUILLEMINOT, MD

CONTACT

01 41 70 81 19; jean.guilleminot@ght-gpne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 8, 2022
• Study Start: April 14, 2022
• Primary Completion: August 14, 2022
• Study Completion: October 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)