NCT05471895

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 9, 2023

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 21, 2022

Last Update Submit

January 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Véronique PERETTI, MD

    CHU La Réunion

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aïda Rakotoarinosy

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

January 1, 2023

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

January 9, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share