ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

NCT03749044 | Completed

• 1 other identifier: ASA Pattern MP-37-2018-3915
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia is a serious maternal condition affecting up to 5% of pregnancies from the general population and up to 30% of lupus pregnancies. Aspirin (acetylsalicylic acid- ASA) has been shown to reduce the risk of preeclampsia, by half, in women at high risk. Therefore, it is recommended that health professionals initiate aspirin early during pregnancy in women with lupus. Despite this recommendation, there are currently no studies of aspirin in women with lupus for this indication. This is a critical knowledge gap as aspirin could potentially have a large benefit in this high-risk population. The investigator will perform a RCT to evaluate the effect of a specifically designed patient educational tool on preeclampsia knowledge and ASA adherence in pregnant women with SLE. The research efforts will improve reproductive health of SLE women and the outcomes of offsprings.

Conditions

Pre-Eclampsia; Pregnancy Complications; Systemic Lupus

Keywords

Adverse Pregnancy Outcomes; SLE; Aspirin Adherence

Outcome Measures

Primary Outcomes (1)

• 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

  Responses to preeclampsia knowledge questionnaire will be compared at baseline (before randomization) and at second trimester. Questionnaire includes 20 questions, both closed and open ended, regarding preeclampsia implications, symptoms, role of aspirin for its prevention and actions that should be taken if patient experiences preeclampsia symptoms. The questionnaire total score ranges from 0 to 20, with higher score indicating better preeclampsia knowledge. The questionnaire will be scored by 2 independent investigators calculating the number of correct responses. Subjects will be randomized in a 1:1 ratio to either patient educational tool or standard of care. SLE specific educational tool consists of sheet displaying the previously developed patient education form on recto. On verso SLE-specific information related to the risk of preeclampsia in SLE pregnancies and the estimated efficacy of ASA in reducing preeclampsia risk in women at high risk are displayed.

  Change from up to and including 12 weeks of pregnancy (baseline) and between 20-24 weeks of pregnancy (second trimester)

Secondary Outcomes (3)

• Prevalence of ASA use in Canadian pregnant women with SLE receiving standard of care throughout pregnancy

  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

• ASA adherence in Canadian pregnant women with SLE in experimental and no intervention groups

  Change from up and including 12 weeks of pregnancy (baseline) and between 20-24 weeks of pregnancy (second trimester)

• Assessing ASA adherence using a visual analogue scale in Canadian pregnant women with SLE in experimental and no intervention groups

  Change from up to and including 12 weeks of pregnancy (baseline) and between 20-24 weeks of pregnancy (second trimester)

Study Arms (2)

Patient Educational Tool

EXPERIMENTAL

At the baseline visit, after having responded to the questionnaire, participants in the education arm will be given the patient educational tool.

Other: Patient Educational Tool

Standard of Care

NO INTERVENTION

Subjects in the standard of care arm will not receive the patient educational tool. If participants ask specific questions on pregnancy complications and/or preeclampsia, the clinicians will provide relevant information as they judge appropriate, but without handing out the patient educational tool.

Interventions

Patient Educational Tool OTHER

This tool is a modified version of the patient educational sheet elaborated and validated by You et al in collaboration with the Preeclampsia Foundation. This patient educational sheet graphically defines preeclampsia and its. A licensing agreement has been obtained from the Preeclampsia Foundation, with the rights to modify the educational tool for this RCT. The SLE-specific educational tool will consist in a sheet displaying the previously developed patient educational form on the recto. However, on the verso of the sheet, SLE-specific information related to the risk of preeclampsia in SLE pregnancies and the estimated efficacy of ASA in reducing preeclampsia risk in women at high risk are displayed.

Patient Educational Tool

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with a SLE diagnosis based on the SLICC classification criteria;
• English and/or French speaking;
• Followed at participating sites;
• Gestational age up to 16-6/7 weeks\* inclusively
• Between the ages of 18 and 45 years;
• Only one pregnancy per woman will be included in the project;
• Single or multiple intrauterine pregnancies are permitted;
• Must be participating in the LEGACY Biobank. \*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 do not speak English or French;
• Women who are not followed at participating sites;
• Gestational age at 17 weeks and above
• Under the age of 18 and over the age of 45;
• More than one pregnancy per woman will not be included in the project;
• Women with extrauterine pregnancies;
• Women who are not participating in the LEGACY Biobank;
• 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;
• Men are not eligible for this study.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• University of Calgary: collaborator
• University of Toronto: collaborator
• Dalhousie University: collaborator
• University of British Columbia: collaborator
• University of Manitoba: collaborator
• University Health Network, Toronto: collaborator
• Laval University: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3S9, Canada

Location

Related Publications (6)

• You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.

  PMID: 22542120 BACKGROUND

• You WB, Wolf M, Bailey SC, Pandit AU, Waite KR, Sobel RM, Grobman W. Factors associated with patient understanding of preeclampsia. Hypertens Pregnancy. 2012;31(3):341-9. doi: 10.3109/10641955.2010.507851. Epub 2010 Sep 22.

  PMID: 20860492 BACKGROUND

• 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.

  PMID: 10568906 BACKGROUND

• 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.

  PMID: 8620137 BACKGROUND

• Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009 Jan-Feb;12(1):118-23. doi: 10.1111/j.1524-4733.2008.00400.x.

  PMID: 19911444 RESULT

• Lee JE, Mendel A, Malhame I, Barber MRW, Clarke AE, Fortin PR, Hanly JG, Legge A, Peschken C, Laskin CA, Touma Z, Urowitz MB, Bernatsky S, Vinet E. An educational tool to improve PREeclamPsia knowledge and Aspirin adheRence in lupus prEgnancies: the PREPARE trial. Rheumatology (Oxford). 2025 Nov 1;64(11):5707-5715. doi: 10.1093/rheumatology/keaf334.

  PMID: 40578323 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Evelyne Vinet, MD/PhD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 21, 2018
• Study Start: May 28, 2018
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)