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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Preeclampsia

Treatments: Other: administration of a self-questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04658966

PRERETRO ( 29BRC20.0133)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

207 participants in 2 patient groups

cases

Description:

Women with a history of pre-eclampsia

Treatment:

Other: administration of a self-questionnaire

controls

Description:

Women with no history of hypertensive disorder during pregnancy

Treatment:

Other: administration of a self-questionnaire