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

February 8, 2023 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

378

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand
      • Dijon, France, 21079
        • CHU de Dijon
      • Lille, France, 59037
        • CHU de Lille
      • Limoges, France, 87042
        • CHU de Limoges
      • Nantes, France, 44093
        • CHU de Nantes
      • Nice, France, 06200
        • CHU de Nice
      • Rennes, France, 35000
        • CHU de Rennes
      • Strasbourg, France, 67200
        • CHU de Strasbourg
      • Toulouse, France, 31059
        • CHU de Toulouse
      • Tours, France, 37044
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a diagnosis of systemic sclerosis according to EULAR 2013 diagnostic criteria AND with a history of pregnancy longer than 6 months (28 WG) before systemic sclerosis diagnosis

followed in one of the French centers of expertise for systemic sclerosis will be offered to participate to the study during the annual follow-up consultation with her referring physician.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
History of pre-eclampsia before systemic sclerosis diagnosis
Time Frame: 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 ".
Inclusion (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months
Time Frame: 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.
Inclusion (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2020

Primary Completion (ACTUAL)

May 31, 2022

Study Completion (ACTUAL)

May 31, 2022

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 27, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVASCLERO (29BRC20.0080)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning two year and ending five years following the end study

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe