Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia.
NCT ID: NCT04658966
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
207 participants
OBSERVATIONAL
2020-09-18
2021-06-22
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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cases
Women with a history of pre-eclampsia
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
administration of a self-questionnaire
Women will have to fill in an online self questionnaire on pre-eclampsia
Interventions
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administration of a self-questionnaire
Women will have to fill in an online self questionnaire on pre-eclampsia
Eligibility Criteria
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Inclusion Criteria
* For the cases: with a pre-eclampsia diagnosis during pregnancy
* For the controls: with no history of hypertensive disorder during pregnancy
Exclusion Criteria
* Women unable to read French
* Medical interruption of pregnancy
* Pregnancy with a delivery before 6 months
* Women who refused to participate in the study
18 Years
FEMALE
Yes
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHRU de Brest
Brest, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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PRERETRO ( 29BRC20.0133)
Identifier Type: -
Identifier Source: org_study_id
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