ContraceptionCMCNCT05676762
Contraceptive Counselling: Impact on Awareness of the Risk of Unwanted Pregnancy and on the Appeal of Contraception
An observational study of Contraception, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 117 participants
- Where
- 1 siteReunion
- Study dates
- 15 Mar 2022to 15 Jan 2023
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- 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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Contraception
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between Day 1 and Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Mar 2022
- Primary completion15 Dec 2022
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien LERUSTE, MD, Principal investigator, Universite de La Reunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676762
- Sponsor's protocol ID
- 2021/CHU/34
- Acronym
- CMC
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 9 Jan 2023
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05676762
- Acronym / sponsor ID
- CMC / 2021/CHU/34
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 9 Jan 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of a minimal councelling regarding the contraception awareness of risk of unwanted pregnancy
Time frame: between Day 1 and Month 1
Change of Proportion of women with no contraception and having sexual relations without a desire of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- 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.
Sébastien LERUSTE, MD principal investigator
Universite de La Reunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 7 inclusion and 7 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 9 Jan 2023. 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 Reunion. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of a minimal councelling regarding the contraception awareness of risk of unwanted pregnancy (time frame: between Day 1 and Month 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 9 Jan 2023.