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ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

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ClinicalTrials.gov Identifier: NCT03749044
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
University of Calgary
University of Toronto
Dalhousie University
University of British Columbia
University of Manitoba
University Health Network, Toronto
Laval University
Information provided by (Responsible Party):
Evelyne Vinet, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.


Condition or disease Intervention/treatment Phase
Pre-Eclampsia Pregnancy Complications Systemic Lupus Other: Patient Educational Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Aspirin Patterns of Use and Adherence for Prevention of Preeclampsia in SLE Pregnancies
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient Educational Tool
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
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.

No Intervention: Standard of Care
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.



Primary Outcome Measures :
  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 [ Time Frame: Change from up to and including 12 weeks of pregnancy (baseline) and between 20-24 weeks of pregnancy (second trimester) ]

    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.



Secondary Outcome Measures :
  1. Prevalence of ASA use in Canadian pregnant women with SLE receiving standard of care throughout pregnancy [ Time Frame: 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 ]
    At each 4 pregnancy time points, up to and including 12 weeks gestation (baseline), between 20 - 24 weeks (2nd trimester), between 30-34 weeks (3rd trimester) and at 8 to 12 weeks after delivery, patient self-reported ASA use (i.e. current user versus non-user) will be recorded for all participants.

  2. ASA adherence in Canadian pregnant women with SLE in experimental and no intervention groups [ Time Frame: Change from up and including 12 weeks of pregnancy (baseline) and between 20-24 weeks of pregnancy (second trimester) ]
    In participants, the Adherence to Refills and Medications Scale (ARMS) will measure changes in aspirin adherence at baseline and second trimester visit. The ARMS is a validated self-reported questionnaire developed for patients with chronic diseases with low literacy. It includes 12 short and simple questions, each scored 1 ("always") to 4 ("never"), and the total ranges from 12 to 48, with lower scores indicating higher levels of reported adherence. Investigator will define adherence as a continuous variable using the ARMS score and compare the between-group difference using a logarithmic transformation of ARMS scores at the baseline and 2rd trimester visits.

  3. Assessing ASA adherence using a visual analogue scale in Canadian pregnant women with SLE in experimental and no intervention groups [ Time Frame: Change from up to and including 12 weeks of pregnancy (baseline) and between 20-24 weeks of pregnancy (second trimester) ]

    Changes in the visual analogue scale measuring ASA adherence from baseline to second trimester visit.

    On a scale of 0 to 10 where 0 is never and 10 is always, patient-reported adherence to aspirin use will be measured.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Pregnant women with a SLE diagnosis based on the SLICC classification criteria;
  2. English and/or French speaking;
  3. Followed at participating sites;
  4. Gestational age up to 16-6/7 weeks* inclusively
  5. Between the ages of 18 and 45 years;
  6. Only one pregnancy per woman will be included in the project;
  7. Single or multiple intrauterine pregnancies are permitted;
  8. 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

Exclusion Criteria

  1. Pregnant women who do not meet the SLE diagnosis based on the SLICC classification;
  2. Women who do not speak English or French;
  3. Women who are not followed at participating sites;
  4. Gestational age at 17 weeks and above
  5. Under the age of 18 and over the age of 45;
  6. More than one pregnancy per woman will not be included in the project;
  7. Women with extrauterine pregnancies;
  8. Women who are not participating in the LEGACY Biobank;
  9. Women who cannot provide informed consent due to severe illness;
  10. Women who are cognitively impaired or incapable of understanding the text written on the consent form;
  11. Men are not eligible for this study.

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): NCT03749044


Contacts
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Contact: Evelyne Vinet, MD/PhD 514-934-1934 ext 44735 evelyne.vinet@mcgill.ca
Contact: Elizabeth Turnbull, RN 514-934-1934 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.vinet@mcgill.ca   
Contact: Elizabeth Turnbull, RN    514-934-1934 ext 44831    elizabeth.turnbull@rimuhc.ca   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of Calgary
University of Toronto
Dalhousie University
University of British Columbia
University of Manitoba
University Health Network, Toronto
Laval University
Investigators
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Principal Investigator: Evelyne Vinet, MD/PhD Research Institute of the McGill University Health Centre
Publications of Results:
Other Publications:
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Responsible Party: Evelyne Vinet, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03749044    
Other Study ID Numbers: ASA Pattern MP-37-2018-3915
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Evelyne Vinet, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Adverse Pregnancy Outcomes
SLE
Aspirin Adherence
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced