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

Sponsor

University Hospital, Brest (Other)

Overall Status

Recruiting

CT.gov ID

NCT04658966

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

41.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia	Other: administration of a self-questionnaire

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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.

Actual Study Start Date :

Sep 18, 2020

Anticipated Primary Completion Date :

Sep 18, 2021

Anticipated Study Completion Date :

Sep 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
cases Women with a history of pre-eclampsia	Other: administration of a self-questionnaire Women will have to fill in an online self questionnaire on pre-eclampsia
controls Women with no history of hypertensive disorder during pregnancy	Other: administration of a self-questionnaire Women will have to fill in an online self questionnaire on pre-eclampsia

Arm

Intervention/Treatment

cases

Women with a history of pre-eclampsia

Other: administration of a self-questionnaire

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

controls

Women with no history of hypertensive disorder during pregnancy

Other: administration of a self-questionnaire

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT04658966

Other Study ID Numbers:

PRERETRO ( 29BRC20.0133)

First Posted:

Dec 9, 2020

Last Update Posted:

Dec 9, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Brest

questionnaire

Additional relevant MeSH terms:

Pre-Eclampsia

Eclampsia

Study Results

No Results Posted as of Dec 9, 2020