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

NCT04658966 | Completed DMC

• 1 other identifier: PRERETRO ( 29BRC20.0133)
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

questionnaire

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

cases

Women with a history of pre-eclampsia

Other: administration of a self-questionnaire

controls

Women with no history of hypertensive disorder during pregnancy

Other: administration of a self-questionnaire

Interventions

administration of a self-questionnaire OTHER

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

cases; controls

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who gave birth after a pregnancy of more than 6 months at Brest University Hospital between January 2002 and December 2014
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases will be women with a history of pre-eclampsia before 2015 and controls will be women with no history of hypertensive disorder during pregnancy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related Publications (6)

• 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 severe pre-eclampsia (PE). Experts' guidelines 2008. Societe francaise d'anesthesie et de reanimation. College national des gynecologues et obstetriciens francais. Societe francaise de medecine perinatale. Societe francaise de neonatalogie]. Ann Fr Anesth Reanim. 2009 Mar;28(3):275-81. doi: 10.1016/j.annfar.2009.02.015. Epub 2009 Mar 24. No abstract available. French.

  PMID: 19321292 RESULT

• 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 13. French.

  PMID: 24035736 RESULT

• 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.

  PMID: 17975258 RESULT

• 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. doi: 10.1186/ar3510. Epub 2011 Nov 4.

  PMID: 22053948 RESULT

• 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.

  PMID: 29344946 RESULT

• 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.2007.09.038. Epub 2008 Feb 1.

  PMID: 18241822 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: September 18, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the end study
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)