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 |
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Recruitment Status :
Recruiting
First Posted : April 27, 2020
Last Update Posted : December 3, 2020
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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 |
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| Systemic Sclerosis Preeclampsia Vascular Complications |
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 |
| 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 |
| Group/Cohort |
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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.
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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.
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- 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 ".
- 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.
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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 |
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.
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
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
| Contact: Claire DE MOREUIL | 02 98 34 74 93 | claire.demoreuil@chu-brest.fr |
| 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 | |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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systemic sclerosis vascular phenotype pre-eclampsia |
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Pre-Eclampsia Eclampsia Scleroderma, Systemic Scleroderma, Diffuse Sclerosis |
Pathologic Processes Hypertension, Pregnancy-Induced Pregnancy Complications Connective Tissue Diseases Skin Diseases |