Preeclampsia Clinical Trial
— PREVASCLEROOfficial title:
Is a History of Pre-eclampsia Before Systemic Sclerosis Onset a Risk Factor for Vascular Phenotype in Women With Systemic Sclerosis?
Verified date | February 2023 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Pre-eclampsia, defined by the association of an arterial hypertension and significant proteinuria after 20 weeks of gestation, complicates 1 to 2% of pregnancies in France. Its pathophysiology involves angiogenesis impairment, upregulated maternal systemic inflammatory response, activation of oxidative stress and endothelial dysfunction. In a recent Danish nation-wide cohort study, pre-eclampsia was associated with a 69% increased risk of later developing scleroderma. Type of study: prospective observational case-control study. Primary objective of the study: to determine if a history of pre-eclampsia before systemic sclerosis diagnosis is an independent risk factor for vascular phenotype in sclerodermic women. Secondary objective: to describe all risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months before scleroderma diagnosis.
Status | Completed |
Enrollment | 378 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - General: Women with a diagnosis of systemic sclerosis according to EULAR 2013 diagnostic criteria AND with a history of pregnancy longer than 6 months (28 weeks of gestation (WG)) before systemic sclerosis diagnosis. - Specific: For the women of the " case " group : Women with vascular complications specific of systemic sclerosis (digital ulcers, specific cardiac involvement of systemic sclerosis including pulmonary arterial hypertension, renal crisis). For the women of the " control " group : Women with no vascular complications specific of systemic sclerosis. Non inclusion criteria : - Refusal to participate to the study - Minor women - Women under tutorship - Women with no pregnancy history or with a history of pregnancy(ies) below 6 months length. Exclusion Criteria: - Women aged of less than 18 years - Women on legal protection - Women with no history of pregnancy of more than 6 months - Women unable to fill out a questionnaire in French - Women who refuse to participate to the study |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
France | CHU de Dijon | Dijon | |
France | CHU de Lille | Lille | |
France | CHU de Limoges | Limoges | |
France | CHU de Nantes | Nantes | |
France | CHU de Nice | Nice | |
France | CHU de Rennes | Rennes | |
France | CHU de Strasbourg | Strasbourg | |
France | CHU de Toulouse | Toulouse | |
France | CHU de Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
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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. — View Citation
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | History of pre-eclampsia before systemic sclerosis diagnosis | Primary outcome will be evaluated by the proportion of women with a history of pre-eclampsia before systemic sclerosis diagnosis in each group. Primary judgement criterion will be the response of a woman to the " pre-eclampsia questionnaire ". The aim is to determine if a history of pre-eclampsia before systemic sclerosis diagnosis is an independent prognostic factor for vascular phenotype in sclerodermic women.
Primary judgement criterion: Responses of the women to the " pre-eclampsia questionnaire ". |
Inclusion (Day 0) | |
Secondary | Risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months | Secondary outcomes will be evaluated by the proportion of women with chronic hypertension, diffuse systemic sclerosis, disease duration > 5 years, anti-centromere antibodies, anti-Scl70 antibodies, antiphospholipid antibodies, antiphospholipid syndrome, interstitial lung disease, and tobacco use, in each group, mean age at systemic sclerosis diagnosis in each group. Secondary judgement criteria will be patients' clinical, biological and radiological medical data. The aim is to describe all risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months. | Inclusion (Day 0) |
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