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 : February 17, 2020
|Condition or disease|
|Systemic Lupus Erythematosus Pregnancy Complications|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|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, 2023|
|Estimated Study Completion Date :||January 30, 2024|
- 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.
- 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.
- 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.
- 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
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
|Contact: Evelyne Vinet, MD/PhD||514-934-1934 ext email@example.com|
|Contact: Elizabeth Turnbull, RN||574-394-1934 ext firstname.lastname@example.org|
|Principal Investigator:||Evelyne Vinet, MD/PhD||Research Institute of the McGill University Health Centre|