Status:
COMPLETED
Is a History of Pre-eclampsia a Risk Factor for Vascular Phenotype in Women With Systemic Sclerosis?
Lead Sponsor:
University Hospital, Brest
Conditions:
Systemic Sclerosis
Preeclampsia
Eligibility:
FEMALE
18-90 years
Brief Summary
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 pathophysi...
Detailed Description
Background : Pre-eclampsia is defined by the association of an arterial hypertension and significant proteinuria after 20 weeks of gestation. It complicates 1 to 2% of pregnancies in France. Its path...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT04363021
Start Date
July 6 2020
End Date
May 31 2022
Last Update
February 9 2023
Active Locations (10)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
2
CHU de Dijon
Dijon, France, 21079
3
CHU de Lille
Lille, France, 59037
4
CHU de Limoges
Limoges, France, 87042