Study Summary
This trial will help to improve the reproductive health of women with lupus by testing whether a patient educational tool can help them better understand and adhere to taking aspirin, which has been shown to reduce the risk of preeclampsia.
Eligible Conditions
- Pre-Eclampsia
- Systemic Lupus Erythematosus (SLE)
- Pregnancy Complications
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Up to and including 12 weeks of pregnancy, at 20 to 24 weeks of pregnancy, at 30 to 34 weeks of pregnancy, and 8 to 12 weeks after delivery
Week 24
ASA adherence in Canadian pregnant women with SLE in experimental and no intervention groups
Week 24
Assessing ASA adherence using a visual analogue scale in Canadian pregnant women with SLE in experimental and no intervention groups
Change in preeclampsia knowledge in Canadian pregnant women with SLE exposed to an educational tool on preeclampsia versus Canadian women with SLE not exposed to an educational tool
Week 34
Prevalence of ASA use in Canadian pregnant women with SLE receiving standard of care throughout pregnancy
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard of Care
1 of 2
Patient Educational Tool
1 of 2
Active Control
Experimental Treatment
80 Total Participants · 2 Treatment Groups
Primary Treatment: Patient Educational Tool · No Placebo Group · N/A
Patient Educational Tool
Other
Experimental Group · 1 Intervention: Patient Educational Tool · Intervention Types: OtherStandard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to and including 12 weeks of pregnancy, at 20 to 24 weeks of pregnancy, at 30 to 34 weeks of pregnancy, and 8 to 12 weeks after delivery
Who is running the clinical trial?
University of ManitobaOTHER
540 Previous Clinical Trials
187,082 Total Patients Enrolled
University of TorontoOTHER
633 Previous Clinical Trials
721,744 Total Patients Enrolled
2 Trials studying Pre-Eclampsia
119 Patients Enrolled for Pre-Eclampsia
University Health Network, TorontoOTHER
1,382 Previous Clinical Trials
473,395 Total Patients Enrolled
1 Trials studying Pre-Eclampsia
50 Patients Enrolled for Pre-Eclampsia
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
399 Previous Clinical Trials
125,442 Total Patients Enrolled
2 Trials studying Pre-Eclampsia
2,723 Patients Enrolled for Pre-Eclampsia
Dalhousie UniversityOTHER
155 Previous Clinical Trials
340,902 Total Patients Enrolled
1 Trials studying Pre-Eclampsia
69 Patients Enrolled for Pre-Eclampsia
University of British ColumbiaOTHER
1,327 Previous Clinical Trials
1,534,507 Total Patients Enrolled
4 Trials studying Pre-Eclampsia
90,824 Patients Enrolled for Pre-Eclampsia
University of CalgaryOTHER
706 Previous Clinical Trials
493,621 Total Patients Enrolled
1 Trials studying Pre-Eclampsia
84 Patients Enrolled for Pre-Eclampsia
Laval UniversityOTHER
391 Previous Clinical Trials
164,868 Total Patients Enrolled
5 Trials studying Pre-Eclampsia
10,995 Patients Enrolled for Pre-Eclampsia
Evelyne Vinet, MD/PhDPrincipal InvestigatorResearch Institute of the McGill University Health Centre
1 Previous Clinical Trials
100 Total Patients Enrolled
Eligibility Criteria
Age 18 - 45 · Female Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are pregnant and have a SLE diagnosis based on the SLICC classification criteria.
References
- Bland, J M., and D. G Altman. 1996. “Statistics Notes: The Use of Transformation When Comparing Two Means”. Bmj. BMJ. doi:10.1136/bmj.312.7039.1153.
- You, Whitney B., Michael Wolf, Stacy Cooper Bailey, Anjali U. Pandit, Katherine R. Waite, Rina M. Sobel, and William Grobman. 2010. “Factors Associated with Patient Understanding of Preeclampsia”. Hypertension in Pregnancy. Informa UK Limited. doi:10.3109/10641955.2010.507851.
- Buyon, Jill P, Kenneth C Kalunian, Rosalind Ramsey-Goldman, Michelle A Petri, Michael D Lockshin, Guillermo Ruiz-Irastorza, and Munther Khamashta. 1999. “Assessing Disease Activity in SLE Patients During Pregnancy”. Lupus. SAGE Publications. doi:10.1191/096120399680411272.
- You, Whitney B., Michael S. Wolf, Stacy C. Bailey, and William A. Grobman. 2012. “Improving Patient Understanding of Preeclampsia: A Randomized Controlled Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2012.03.006.
- Kripalani, Sunil, Jessica Risser, Margaret E. Gatti, and Terry A. Jacobson. 2009. “Development and Evaluation of the Adherence to Refills and Medications Scale (ARMS) Among Low-literacy Patients with Chronic Disease”. Value in Health. Elsevier BV. doi:10.1111/j.1524-4733.2008.00400.x.
- You, Whitney B., Michael S. Wolf, Stacy C. Bailey, and William A. Grobman. 2012. “Improving Patient Understanding of Preeclampsia: A Randomized Controlled Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2012.03.006.
- Bland JM, Altman DG. The use of transformation when comparing two means. BMJ. 1996 May 4;312(7039):1153. doi: 10.1136/bmj.312.7039.1153. No abstract available.
- Buyon JP, Kalunian KC, Ramsey-Goldman R, Petri MA, Lockshin MD, Ruiz-Irastorza G, Khamashta M. Assessing disease activity in SLE patients during pregnancy. Lupus. 1999;8(8):677-84. doi: 10.1191/096120399680411272. No abstract available.
- Evelyne Vinet 2018. "ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03749044.
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