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

Preeclampsia Clinical Trial

— PRERETRO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04658966
• Other study ID #: PRERETRO ( 29BRC20.0133)
• Status: Completed
• Start date: September 18, 2020
• Est. completion date: June 22, 2021

Study information

• Verified date: February 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• administration of a self-questionnaire
Women will have to fill in an online self questionnaire on pre-eclampsia

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (6)

Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1. — View Citation

Diehl CL, Brost BC, Hogan MC, Elesber AA, Offord KP, Turner ST, Garovic VD. Preeclampsia as a risk factor for cardiovascular disease later in life: validation of a preeclampsia questionnaire. Am J Obstet Gynecol. 2008 May;198(5):e11-3. doi: 10.1016/j.ajog — View Citation

Kamper-Jorgensen M, Gammill HS, Nelson JL. Preeclampsia and scleroderma: a prospective nationwide analysis. Acta Obstet Gynecol Scand. 2018 May;97(5):587-590. doi: 10.1111/aogs.13296. Epub 2018 Feb 8. — View Citation

Saucedo M, Deneux-Tharaux C, Bouvier-Colle MH; Le Comite national d'experts sur la mortalite maternelle. [Maternal mortality in France, 2007-2009]. J Gynecol Obstet Biol Reprod (Paris). 2013 Nov;42(7):613-27. doi: 10.1016/j.jgyn.2013.06.011. Epub 2013 Sep — View Citation

Societe francaise d'anesthesie et de reanimation (Sfar); College national des gynecologues et obstetriciens francais (CNGOF); Societe francaise de medecine perinatale (SFMP); Societe francaise de neonatalogie (SFNN). [Multidisciplinary management of sever — View Citation

van Wyk L, van der Marel J, Schuerwegh AJ, Schouffoer AA, Voskuyl AE, Huizinga TW, Bianchi DW, Scherjon SA. Increased incidence of pregnancy complications in women who later develop scleroderma: a case control study. Arthritis Res Ther. 2011;13(6):R183. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate diagnostic sensitivity and specificity of the self questionnaire	Presence or not of a history pre-eclampsia according to responses to the questionnaire	Inclusion ( Day 0)