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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Control Trial|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749044
|Contact: Evelyne Vinet, MD/PhD||514-934-1934 ext email@example.com|
|Contact: Elizabeth Turnbull, RN||514-934-1934 ext firstname.lastname@example.org|
|Principal Investigator:||Evelyne Vinet, MD/PhD||Research Institute of the McGill University Health Centre|