Sexual ViolenceIVIIRunNCT05471895
Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
An observational study of Sexual Violence and Abortion, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
According to the figures for the last three years collected from the Indian Ocean Regional Health Observatory, it appears to be about twice as many voluntary terminations of pregnancy on the island of Reunion compared with France metropolitain region. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Violence, Abortion
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jun 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 years and older
- Women only
- Adult, Older adult
Study population: Each centre receives an average of 15 patients per day for pre-abortion consultations. Expectation of 7 fully completed questionnaires per day per centre, then approximately 1000 fully completed questionnaires for a total of 8 weeks.
Who may be able to join
- Adult patient coming for an abortion request at the CHU SUD and NORD, at the GHER and at the CEPS for the CHOR (Reunion Island)
Who cannot join
- Patient coming to the above-mentioned centres for a "post-abortion" consultation.
- <18 years
- Patient who does not speak French.
- Illiterate patient.
- Patient who has already completed the questionnaire.
- Patient refusing to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact Des Violences Sexuelles Sur l'Incidence Des Interruptions Volontaires de Grossesses à La Réunion/ Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
According to the figures for the last three years collected from the Indian Ocean Regional Health Observatory, it appears to be about twice as many voluntary terminations of pregnancy on the island of Reunion compared with France metropolitain region.
Furthermore, the overseas section in 2002, which looked at violence against women of all types in three different spheres of life (the marital sphere, the workplace and public spaces), tends to show a much higher incidence of sexual violence than in metropolitain France.
Read more
This trend seems to be confirmed by the overseas section of the VIRAGE survey started in 2018 on the island.
Furthermore, data found in a qualitative study conducted in Ile de France in 2013 seems to demonstrate a more frequent use of abortion among patients who are victims of sexual violence.
Thus, thiçs study will consist in evaluating the impact of sexual violence on the incidence of voluntary termination of pregnancy in Reunion Island.
- Conditions
- Sexual Violence, Abortion
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women victims of sexual abuse coming for a voluntary termination of pregnancy
Number of patients coming for a voluntary termination of pregnancy sexually abused
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study startJan 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique PERETTI, MD, Principal investigator, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471895
- Sponsor's protocol ID
- 2021/CHU/28
- Acronym
- IVIIRun
- 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
- Impact Des Violences Sexuelles Sur l'Incidence Des Interruptions Volontaires de Grossesses à La Réunion/ Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
- ClinicalTrials.gov ID
- NCT05471895
- Acronym / sponsor ID
- IVIIRun / 2021/CHU/28
- Conditions
- Sexual Violence, Abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Jul 2022 (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.
According to the figures for the last three years collected from the Indian Ocean Regional Health Observatory, it appears to be about twice as many voluntary terminations of pregnancy on the island of Reunion compared with France metropolitain region.
Furthermore, the overseas section in 2002, which looked at violence against women of all types in three different spheres of life (the marital sphere, the workplace and public spaces), tends to show a much higher incidence of sexual violence than in metropolitain France.
This trend seems to be confirmed by the overseas section of the VIRAGE survey started in 2018 on the island.
Furthermore, data found in a qualitative study conducted in Ile de France in 2013 seems to demonstrate a more frequent use of abortion among patients who are victims of sexual violence.
Thus, thiçs study will consist in evaluating the impact of sexual violence on the incidence of voluntary termination of pregnancy in Reunion Island.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Each centre receives an average of 15 patients per day for pre-abortion consultations. Expectation of 7 fully completed questionnaires per day per centre, then approximately 1000 fully completed questionnaires for a total of 8 weeks.
Key inclusion criteria (1 listed)
- Adult patient coming for an abortion request at the CHU SUD and NORD, at the GHER and at the CEPS for the CHOR (Reunion Island)
Key exclusion criteria (6 listed)
- Patient coming to the above-mentioned centres for a "post-abortion" consultation.
- <18 years
- Patient who does not speak French.
- Illiterate patient.
- Patient who has already completed the questionnaire.
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
Proportion of women victims of sexual abuse coming for a voluntary termination of pregnancy
Time frame: Day 1
Number of patients coming for a voluntary termination of pregnancy sexually abused
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.
Véronique PERETTI, MD principal investigator
CHU La Réunion
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Violence and Abortion, run by Centre Hospitalier Universitaire de la Réunion.
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 1 inclusion and 6 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.
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?
Contact Aïda Rakotoarinosy (02 62 35 90 00, rkt.aida@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women victims of sexual abuse coming for a voluntary termination of pregnancy (time frame: Day 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.