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The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies (LEGACY)

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ClinicalTrials.gov Identifier: NCT03746028
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Duke University
University of California, Los Angeles
Dalhousie University
Hanyang University
Hospital for Special Surgery, New York
Johns Hopkins University
Monash University
New York University
Oklahoma Medical Research Foundation
University of North Carolina
Temple University
University of Alabama at Birmingham
University of Birmingham
University of Calgary
University of California
University of Copenhagen
University of Manitoba
University of Michigan
University of Toronto
NYU Langone Health
University of British Columbia
National Institute of Medical Science & Nutrition
Laval University
University Health Network, Toronto
Information provided by (Responsible Party):
Evelyne Vinet, McGill University Health Center

Brief Summary:
The goal is to evaluate adverse pregnancy outcomes (APO), their predictors and potential preventive therapies, such as aspirin (ASA). The investigator aims to improve the outcomes for women with SLE and offsprings. By quantifying the risk of APO conferred by clinical risk factors that can be assessed early in pregnancy (i.e. first trimester), health professionals could be better equipped to estimate the individual risk of SLE pregnancies and the need for heightened surveillance and guide counseling for prophylactic measures, including ASA. Moreover findings from this study could eventually lead to the choice and weighting of first trimester clinical factors in future clinical prediction models for APO in SLE. The investigator's research efforts will improve reproductive health of SLE women, "mitigating the damage, functional loss, and disability that result from a chronic inflammatory disorder", such as SLE.

Condition or disease
Systemic Lupus Erythematosus Pregnancy Complications

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Risk of adverse pregnancy outcomes in pregnant women with SLE [ Time Frame: Up until 28 days after end of pregnancy ]
    Fetal death, neonatal death, preterm delivery or termination of pregnancy, and small for gestational age neonate confirmed by chart review and autopsy report.

  2. Change in patterns of ASA use in the LEGACY cohort from baseline ( <or equal to 12 weeks gestation) to end of pregnancy [ Time Frame: From ≤ 12 weeks gestation (baseline) to 8-12 weeks after delivery (postpartum) ]
    The Adherence to Refills and Medications Scale (ARMS), a validated self-reported questionnaire developed for patients with chronic disease with low literacy, measures ASA adherence. A self-reported aspirin adherence questionnaire consisting of 3 to 6 questions about the use of aspirin during current pregnancy measures ASA use. A visual analogue scale from 0 to 10 measures frequency of ASA ingestion. Change in ASA use will be measured by the questionnaires. Frequencies of dosage of ASA will also be measured.


Secondary Outcome Measures :
  1. Baseline predictors of adverse pregnancy outcomes [ Time Frame: First trimester (up to 20 weeks) ]

    Baseline covariates such as lupus anticoagulant antibodies, a subtype of anticoagulant antibodies, Antiphosphatidylserine/prothrombin antibodies (aPS/PT), antihypertensive use, disease activity, platelet levels will be measured and defined by the physician-in-charge. Nephritis history, race/ethnicity, nulliparity, maternal age, pre-gestational diabetes, obsesity (BMI above 30) and medication use (corticosteroids, antimalarials, immunosuppressive and low-dose aspirin) will be characterized.

    Measures for disease activity include the SLE Pregnancy Disease Activity Index (SLEPDAI), a widely-recognized adaptation of the validated SLE Disease Activity Index, reflects disease activity in pregnancy context.


  2. Comparison of Antiphosphatidylserine/prothrombin antibodies (aPS/PT) in SLE pregnancies from ≤ 12 weeks pregnant (baseline) to 8-12 weeks after delivery (postpartum) [ Time Frame: From ≤ 12 weeks gestation (baseline) to 8-12 weeks after delivery (postpartum) ]
    Positive results for Antiphosphatidylserine/prothrombin antibodies (aPS/PT) and and lupus anticoagulant results in pregnant women with SLE with and without adverse pregnancy outcomes


Biospecimen Retention:   Samples With DNA
In order to achieve these objectives, clinical data and blood sample results obtained through the MUHC LEGACY Biobank (directed by Dr. Evelyne Vinet) will be analysed. The objective of the LEGACY Biobank (the "Bank") is the conservation of blood samples; more specifically, plasma, sera, and crude white cell pellet and clinical data ("material/data") collected from an international multi-centre prospective cohort of pregnant women with systemic lupus erythematosus (SLE).


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
In accordance with the Biobank Management Framework. Participation will take place at the Systemic Lupus International Collaborating Clinics (SLICC) centres in Canada (including the Montreal General Hospital), in the United States, and in Mexico, Denmark, South Korea, and Australia. (The SLICC group represents rheumatologists interested in lupus from over 30 centres and 14 countries with a strong publication record in lupus research.) Recruitment will also take place at other sites that are not part of the SLICC group in Canada and the United States.
Criteria

Patient recruitment, consent, management and storage of data/samples will be done in accordance with the Biobank Management Framework. The LEGACY Biobank informed consent forms will be used to obtain participant consent.

Inclusion criteria:

  1. Pregnant women with a SLE diagnosis based on the SLICC classification criteria;
  2. Followed at participating sites;
  3. English and French speaking;
  4. Gestational age under or equal to 12 weeks;
  5. Between the ages of 18 and 45 years;
  6. More than one pregnancy per subject is allowed for the LEGACY Biobank; however, only one pregnancy per subject will be included for women taking part in the Aspirin patterns of use and adherence for preeclampsia in SLE pregnancies;
  7. Single and multiple intrauterine pregnancies are permitted.

Exclusion Criteria

  1. Pregnant women who do not meet the SLE diagnosis based on the SLICC classification;
  2. Women who are not followed at participating sites;
  3. Women who do not speak English or French;
  4. Gestational age over 12 weeks;
  5. Under the age of 18 and over the age of 45;
  6. Men are not eligible for this biobank;
  7. Women with extrauterine pregnancies;
  8. Women who cannot provide informed consent due to severe illness;
  9. Women who are cognitively impaired or incapable of understanding the text written on the consent form.

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): NCT03746028


Contacts
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Contact: Evelyne Vinet, MD/PhD 514-934-1934 ext 44075 evelyne.vinet@mcgill.ca
Contact: Elizabeth Turnbull, RN 574-394-1934 ext 44831 elizabeth.turnbull@rimuhc.ca

Locations
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Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H4A 3S9
Contact: Evelyne Vinet, MD/PhD    514-934-1934 ext 44075    evelyne.vintet@mcgill.ca   
Contact: Alexandra Sirois, MSc    705-929-1135    alexandra.sirois@rimuhc.ca   
Sponsors and Collaborators
McGill University Health Center
Duke University
University of California, Los Angeles
Dalhousie University
Hanyang University
Hospital for Special Surgery, New York
Johns Hopkins University
Monash University
New York University
Oklahoma Medical Research Foundation
University of North Carolina
Temple University
University of Alabama at Birmingham
University of Birmingham
University of Calgary
University of California
University of Copenhagen
University of Manitoba
University of Michigan
University of Toronto
NYU Langone Health
University of British Columbia
National Institute of Medical Science & Nutrition
Laval University
University Health Network, Toronto
Investigators
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Principal Investigator: Evelyne Vinet, MD/PhD Research Institute of the McGill University Health Centre

Additional Information:
Publications:

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Responsible Party: Evelyne Vinet, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03746028     History of Changes
Other Study ID Numbers: LEGACY - MP-37-2018-3707 (MP)
384331 ( Other Grant/Funding Number: CIHR )
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information will be kept between investigators.

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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 Evelyne Vinet, McGill University Health Center:
Adverse Pregnancy Outcomes
SLE

Additional relevant MeSH terms:
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Pregnancy Complications
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases