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Completed

NCT Number: NCT04658966

Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia.

PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

About this study

This study will help to evaluate the specificity and sensitivity of the French translation of a self-questionnaire looking for a history of pre-eclampsia in women who gave birth at Brest University Hospital before year 2015.

First, women with pre-eclampsia (cases) and women with no hypertensive disorders (controls) during pregnancy were identified with the Medical Registry Database (MRD) of Brest University maternity ward.

All pre-eclampsia diagnoses were reviewed by 2 experts in order to confirm the accuracy of the diagnosis.

250 cases and 250 controls were finally selected after consultation of their medical file and were pre-included in the study.

Then, the 500 women will be contacted by phone or e-mail in order to inform them about the study and to offer them the possibility to participate in the study.

The women who will agree to participate in the study will fill in an online self-questionnaire on pre-eclampsia.

Their responses will then be compared to the diagnosis retained after consultation of their medical file.

Sensitivity and specificity of the questionnaire will then be evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who gave birth after a pregnancy of more than 6 months at Brest University Hospital between January 2002 and December 2014
  • For the cases: with a pre-eclampsia diagnosis during pregnancy
  • For the controls: with no history of hypertensive disorder during pregnancy

Exclusion criteria

  • Women Under legal protection
  • Women unable to read French
  • Medical interruption of pregnancy
  • Pregnancy with a delivery before 6 months
  • Women who refused to participate in the study

Treatment and study plan

administration of a self-questionnaire

Other

Women will have to fill in an online self questionnaire on pre-eclampsia

Primary outcomes

  1. Evaluate diagnostic sensitivity and specificity of the self questionnaire

    Time frame: Inclusion ( Day 0)

    Presence or not of a history pre-eclampsia according to responses to the questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia of More Than 5 Years in Women Who Have Already Had a Pregnancy of More Than 6 Months With Childbirth at Brest University Hospital.

Acronym: PRERETRO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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