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

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ClinicalTrials.gov Identifier: NCT04363021
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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
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.

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Study Type : Observational
Estimated 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 : July 6, 2020
Estimated Primary Completion Date : July 6, 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

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.



Primary Outcome Measures :
  1. 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 ".



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363021


Contacts
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Contact: Claire DE MOREUIL 02 98 34 74 93 claire.demoreuil@chu-brest.fr

Locations
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France
CHU de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Olivier Aumaitre       oaumaitre@chu-clermontferrand.fr   
CHU de Dijon Not yet recruiting
Dijon, France, 21079
Contact: Sabine Berthier       sabine.berthier@chu-dijon.fr   
CHU de Lille Recruiting
Lille, France, 59037
Contact: Eric HACHULLA       eric.hachulla@chru-lille.fr   
CHU de Limoges Not yet recruiting
Limoges, France, 87042
Contact: Anne-Laure Fauchais       alfauchais@orange.fr   
CHU de Nantes Not yet recruiting
Nantes, France, 44093
Contact: Christian Agard       christian.agard@chu-nantes.fr   
CHU de Nice Recruiting
Nice, France, 06200
Contact: Viviane Queyrel       queyrel-moranne.v@chu-nice.fr   
CHU de Rennes Not yet recruiting
Rennes, France, 35000
Contact: Alain Lescoat       alain.lescoat@chu-rennes.fr   
CHU de Strasbourg Not yet recruiting
Strasbourg, France, 67200
Contact: Emmanuel Chatelus       emmanuel.chatelus@chru-strasbourg.fr   
CHU de Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Gregory Pugnet       pugnet.g@chu-toulouse.fr   
CHU de Tours Recruiting
Tours, France, 37044
Contact: Elisabeth Diot       elisabeth.diot@univ-tours.fr   
Sponsors and Collaborators
University Hospital, Brest
Publications:

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04363021    
Other Study ID Numbers: PREVASCLERO (29BRC20.0080)
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning two year and ending five years following the end study
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
systemic sclerosis
vascular phenotype
pre-eclampsia
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Connective Tissue Diseases
Skin Diseases