Contraceptive Counselling: Impact on Awareness of the Risk of Unwanted Pregnancy and on the Appeal of Contraception (CMC)

Le Conseil Minimal Autour de la Contraception : Quel Impact Sur la Prise de Conscience du Risque de Grossesse Non désirée et Sur l'Attrait à la Contraception

The hypothesis of this study is that the generalisation of minimal contraceptive advice in general medical consultations among women of childbearing age in Reunion Island who do not use contraception but who have sexual relations and do not wish to become pregnant within the year could induce an awareness of the risk of unwanted pregnancy and lead to a change in behaviour with regard to contraceptive methods.

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Réunion
  • Saint-Philippe, Réunion, 97442
    • Cabinet de médecine générale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

On the basis of 30 participating GPs, the estimation of the number of inclusions is 400 women, which seems sufficient for this study.

The desired number of inclusions is 45 women/month (400 women over 9 months).

Description

Inclusion Criteria:

• Women from 18 to 50 years old
• Consulting in a general practice in Reunion Island
• French or Creole speaking
• Not having any contraceptive means
• Having sexual intercourse
• Not having any desire to become pregnant within the year
• Collection of non-opposition

Exclusion Criteria:

• Consultation for a desire or follow-up of a pregnancy
• Consultation for an abortion
• Consultation for a contraceptive method
• Known infertility
• Inability to answer the telephone (hearing impaired, mute)
• Severe cognitive disorder (mental retardation, dementia, active psychosis)
• Women under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of a minimal councelling regarding the contraception awareness of risk of unwanted pregnancy	Change of Proportion of women with no contraception and having sexual relations without a desire of pregnancy	between Day 1 and Month 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Sébastien LERUSTE, MD, Universite de La Reunion

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Anticipated): January 15, 2023

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021/CHU/34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No