PREVASCLERO: Is a History of Pre-eclampsia a Risk Factor for Vascular Phenotype in Women With Systemic Sclerosis?

Sponsor

University Hospital, Brest (Other)

Overall Status

Recruiting

CT.gov ID

NCT04363021

Collaborator

(none)

378

Enrollment

Locations

26.8

Anticipated Duration (Months)

37.8

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis Preeclampsia Vascular Complications

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 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. A case-control study on 103 women with systemic sclerosis compared to 103 control women had already found an increased incidence of previous vasculoplacental disorders in women with systemic sclerosis. Women developed systemic sclerosis on average 27 years after their first pregnancy.

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.

Conduct of the study:

It is a prospective observational case-control study. Cases will be defined as women with systemic sclerosis, specific vascular complications (digital ulcers, specific cardiac involvement of systemic sclerosis including pulmonary arterial hypertension, renal crisis) and with a previous pregnancy longer than 6 months before systemic sclerosis diagnosis.

Controls will be defined as women with systemic sclerosis, no specific vascular complication and with a previous pregnancy longer than 6 months before systemic sclerosis diagnosis.

Conduct of the study:

A self-administered " pregnancy " questionnaire will be given to each women with systemic sclerosis of the cohort group during the annual follow-up consultation. A case report form will be completed at the same time by the physician in charge of the patient.

The " pregnancy " questionnaire will consist of two parts :

A part " pre-eclampsia questionnaire ", derived from the translation in French of a questionnaire validated in English.
A second part with additional questions on pregnancies. The duration of participation to the study will be of one day. The duration of the inclusion period will be of 24 months. Needed number of patients : 378 women, 126 "cases" and 252 "control" .

Perspectives of the study :

If this study demonstrates that a previous pre-eclampsia is an independent risk factor for vascular phenotype in women with systemic sclerosis, it will be mandatory to look for a history of pre-eclampsia in women at the time of systemic sclerosis diagnosis. Besides, the women with a history of pre-eclampsia should be monitored more frequently for vascular complications related to systemic sclerosis.

Study Design

Study Type:

Observational

Anticipated Enrollment :

378 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Is a History of Pre-eclampsia Before Systemic Sclerosis Onset a Risk Factor for Vascular Phenotype in Women With Systemic Sclerosis?

Actual Study Start Date :

Jul 6, 2020

Anticipated Primary Completion Date :

Jul 6, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
cases Cases will be defined as women with systemic sclerosis, specific vascular complications (digital ulcers, specific cardiac involvement of systemic sclerosis including pulmonary arterial hypertension, renal crisis) and with a previous pregnancy longer than 6 months before systemic sclerosis diagnosis.
controls Controls will be defined as women with systemic sclerosis, no specific vascular complication and with a previous pregnancy longer than 6 months before systemic sclerosis diagnosis.

Outcome Measures

Primary Outcome Measures

History of pre-eclampsia before systemic sclerosis diagnosis [Inclusion (Day 0)]
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 ".

Secondary Outcome Measures

Risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months [Inclusion (Day 0)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	CHU de Nantes	Nantes	France	44093
6	CHU de Nice	Nice	France	06200
7	CHU de Rennes	Rennes	France	35000
8	CHU de Strasbourg	Strasbourg	France	67200
9	CHU de Toulouse	Toulouse	France	31059
10	CHU de Tours	Tours	France	37044