Contraceptive Counselling: Impact on Awareness of the Ris... | NCT05676762

Studies
Contraceptive Counselling: Impact on Awareness of the Risk of Unwanted Pregnancy and on the Appeal of Contraception

NCT05676762

Sponsor

Centre Hospitalier Universitaire de la Réunion

Status

Unknown status

Last Update Posted

Jan 9, 2023Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Contraception

Interventions

Not provided

Countries

Reunion

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2022Actual

Primary Completion Date

Dec 15, 2022Actual

Completion Date

Jan 15, 2023Estimated

First Submitted Date

Jul 21, 2022

First Submission Date that Met QC Criteria

Jan 6, 2023

First Posted Date

Jan 9, 2023Actual

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

Jan 6, 2023

Last Update Posted Date

Jan 9, 2023Actual

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

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sébastien LERUSTE, MD	Universite de La Reunion	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cabinet de médecine générale		Saint-Philippe		97442	Reunion

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided