The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

NCT03746028 | Unknown

• 2 other identifiers: LEGACY - MP-37-2018-3707 (MP)384331
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Pregnancy Complications

Keywords

Adverse Pregnancy Outcomes; SLE

Outcome Measures

Primary Outcomes (2)

• Risk of adverse pregnancy outcomes in pregnant women with SLE

  Fetal death, neonatal death, preterm delivery or termination of pregnancy, and small for gestational age neonate confirmed by chart review and autopsy report.

  Up until 28 days after end of pregnancy

• Change in patterns of ASA use in the LEGACY cohort from baseline ( <or equal to 12 weeks gestation) to end of pregnancy

  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.

  From ≤ 12 weeks gestation (baseline) to 8-12 weeks after delivery (postpartum)

Secondary Outcomes (2)

• Baseline predictors of adverse pregnancy outcomes

  First trimester (up to 20 weeks)

• Comparison of Antiphosphatidylserine/prothrombin antibodies (aPS/PT) in SLE pregnancies from ≤ 12 weeks pregnant (baseline) to 8-12 weeks after delivery (postpartum)

  From ≤ 12 weeks gestation (baseline) to 8-12 weeks after delivery (postpartum)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnant women with a SLE diagnosis based on the SLICC classification criteria;
• Followed at participating sites;
• English and French speaking;
• Gestational age up to 16-6/7 weeks\* inclusively
• Between the ages of 18 and 45 years;
• 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;
• Single and multiple intrauterine pregnancies are permitted. \*Our aim is to recruit subjects under or equal to 12 weeks but we will include pregnancies up to 16-6/7 weeks inclusively.

You may not qualify if:

• Pregnant women who do not meet the SLE diagnosis based on the SLICC classification;
• Women who are not followed at participating sites;
• Women who do not speak English or French;
• Gestational age at 17 weeks and above;
• Under the age of 18 and over the age of 45;
• Men are not eligible for this biobank;
• Women with extrauterine pregnancies;
• Women who cannot provide informed consent due to severe illness;
• Women who are cognitively impaired or incapable of understanding the text written on the consent form.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Duke University: collaborator
• University of California, Los Angeles: collaborator
• Dalhousie University: collaborator
• Hanyang University: collaborator
• Hospital for Special Surgery, New York: collaborator
• Johns Hopkins University: collaborator
• Monash University: collaborator
• New York University: collaborator
• Oklahoma Medical Research Foundation: collaborator
• University of North Carolina: collaborator
• Temple University: collaborator
• University of Alabama at Birmingham: collaborator
• University of Birmingham: collaborator
• University of Calgary: collaborator
• University of California: collaborator
• University of Copenhagen: collaborator
• University of Manitoba: collaborator
• University of Michigan: collaborator
• University of Toronto: collaborator
• NYU Langone Health: collaborator
• University of British Columbia: collaborator
• National Institute of Medical Science & Nutrition: collaborator
• Laval University: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3S9, Canada

RECRUITING

Related Publications (10)

• Buyon JP, Kim MY, Guerra MM, Laskin CA, Petri M, Lockshin MD, Sammaritano L, Branch DW, Porter TF, Sawitzke A, Merrill JT, Stephenson MD, Cohn E, Garabet L, Salmon JE. Predictors of Pregnancy Outcomes in Patients With Lupus: A Cohort Study. Ann Intern Med. 2015 Aug 4;163(3):153-63. doi: 10.7326/M14-2235.

  PMID: 26098843 BACKGROUND

• Petri M, Allbritton J. Fetal outcome of lupus pregnancy: a retrospective case-control study of the Hopkins Lupus Cohort. J Rheumatol. 1993 Apr;20(4):650-6.

  PMID: 8496859 BACKGROUND

• Georgiou PE, Politi EN, Katsimbri P, Sakka V, Drosos AA. Outcome of lupus pregnancy: a controlled study. Rheumatology (Oxford). 2000 Sep;39(9):1014-9. doi: 10.1093/rheumatology/39.9.1014.

  PMID: 10986308 BACKGROUND

• Clowse ME, Jamison M, Myers E, James AH. A national study of the complications of lupus in pregnancy. Am J Obstet Gynecol. 2008 Aug;199(2):127.e1-6. doi: 10.1016/j.ajog.2008.03.012. Epub 2008 May 5.

  PMID: 18456233 BACKGROUND

• Al Arfaj AS, Khalil N. Pregnancy outcome in 396 pregnancies in patients with SLE in Saudi Arabia. Lupus. 2010 Dec;19(14):1665-73. doi: 10.1177/0961203310378669. Epub 2010 Oct 14.

  PMID: 20947541 BACKGROUND

• Ko HS, Ahn HY, Jang DG, Choi SK, Park YG, Park IY, Lee G, Park SH, Shin JC. Pregnancy outcomes and appropriate timing of pregnancy in 183 pregnancies in Korean patients with SLE. Int J Med Sci. 2011;8(7):577-83. doi: 10.7150/ijms.8.577. Epub 2011 Oct 1.

  PMID: 22022210 BACKGROUND

• Liu J, Zhao Y, Song Y, Zhang W, Bian X, Yang J, Liu D, Zeng X, Zhang F. Pregnancy in women with systemic lupus erythematosus: a retrospective study of 111 pregnancies in Chinese women. J Matern Fetal Neonatal Med. 2012 Mar;25(3):261-6. doi: 10.3109/14767058.2011.572310. Epub 2011 Apr 19.

  PMID: 21504337 BACKGROUND

• Shand AW, Algert CS, March L, Roberts CL. Second pregnancy outcomes for women with systemic lupus erythematosus. Ann Rheum Dis. 2013 Apr;72(4):547-51. doi: 10.1136/annrheumdis-2011-201210. Epub 2012 Jun 29.

  PMID: 22753385 BACKGROUND

• Smyth A, Oliveira GH, Lahr BD, Bailey KR, Norby SM, Garovic VD. A systematic review and meta-analysis of pregnancy outcomes in patients with systemic lupus erythematosus and lupus nephritis. Clin J Am Soc Nephrol. 2010 Nov;5(11):2060-8. doi: 10.2215/CJN.00240110. Epub 2010 Aug 5.

  PMID: 20688887 BACKGROUND

• Joseph KS. The fetuses-at-risk approach: clarification of semantic and conceptual misapprehension. BMC Pregnancy Childbirth. 2008 Mar 26;8:11. doi: 10.1186/1471-2393-8-11.

  PMID: 18366767 BACKGROUND

Related Links

• James G, Witten D, Hastie T, Tibshirani R. An Introduction to Statistical Learning-With Applications in R. New York: Springer; 2013.

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).

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Pregnancy Complications

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Evelyne Vinet, MD/PhD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyne Vinet, MD/PhD

CONTACT

514-934-1934; evelyne.vinet@mcgill.ca

Esther Lee, BSc

CONTACT

514-934-1934; esther.lee@rimuhc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 19, 2018
• Study Start: June 6, 2018
• Primary Completion: October 30, 2023
• Study Completion: January 30, 2024
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)