Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 2:09 PM
Study NCT ID:
NCT04658966
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia.
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official 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.
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRERETRO
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: