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

Completed

• Conditions: Preeclampsia
• Interventions: Other: administration of a self-questionnaire

• Registration Number: NCT04658966
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-09-18
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-09
• Primary Completion: 2021-06-22
• Study Completion: 2021-06-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 207

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cases	administration of a self-questionnaire	Women with a history of pre-eclampsia
controls	administration of a self-questionnaire	Women with no history of hypertensive disorder during pregnancy

Primary Outcome Measures

Name	Time	Method
Evaluate diagnostic sensitivity and specificity of the self questionnaire	Inclusion ( Day 0)	Presence or not of a history pre-eclampsia according to responses to the questionnaire

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France