Clinical Trials Directory

Trials / Completed

CompletedNCT04658966

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

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.

Status
Completed
Phase
Study type
Observational
Enrollment
207 (actual)
Sponsor
University Hospital, Brest · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERadministration of a self-questionnaireWomen will have to fill in an online self questionnaire on pre-eclampsia

Timeline

Start date
2020-09-18
Primary completion
2021-06-22
Completion
2021-06-22
First posted
2020-12-09
Last updated
2023-02-09

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04658966. Inclusion in this directory is not an endorsement.