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Educational Tool for Aspirin Adherence in SLE Pregnancies

N/A

Waitlist Available

Led By Evelyne Vinet, MD/PhD

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

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.

Who is the study for?

This trial is for pregnant women aged 18-45 with Systemic Lupus Erythematosus (SLE), up to 16 weeks and 6 days into their pregnancy. Participants must be enrolled in the LEGACY Biobank, speak English or French, and be followed at participating sites. Women over 17 weeks pregnant, with more than one pregnancy in the study, extrauterine pregnancies, severe illness or cognitive impairment are excluded.Check my eligibility

What is being tested?

The trial studies a patient educational tool designed to increase knowledge about preeclampsia and adherence to aspirin therapy among pregnant women with SLE. Aspirin has been shown to halve the risk of preeclampsia in high-risk groups like those with lupus.See study design

What are the potential side effects?

Since this intervention involves an educational tool rather than a medical treatment, there are no direct side effects associated with it. However, general risks related to taking aspirin during pregnancy may include bleeding issues or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patient Educational ToolExperimental Treatment1 Intervention

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

Group II: Standard of CareActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaOTHER

1,415 Previous Clinical Trials

2,466,943 Total Patients Enrolled

2 Trials studying Pre-eclampsia

87,530 Patients Enrolled for Pre-eclampsia

University of ManitobaOTHER

595 Previous Clinical Trials

199,449 Total Patients Enrolled

University of TorontoOTHER

689 Previous Clinical Trials

1,018,570 Total Patients Enrolled

Media Library

Patient Educational Tool Clinical Trial Eligibility Overview. Trial Name: NCT03749044 — N/A

Pre-eclampsia Research Study Groups: Standard of Care, Patient Educational Tool

Pre-eclampsia Clinical Trial 2023: Patient Educational Tool Highlights & Side Effects. Trial Name: NCT03749044 — N/A

Patient Educational Tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT03749044 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of persons enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is still looking for volunteers and was initially posted on 28 May 2018 with the latest update being 23 June 2022. The study needs 80 participants from one location."

Answered by AI

Is it possible for me to be included in this investigation?

"For this study, 80 individuals aged 18 to 45 struggling with adverse birth outcomes must be recruited. To qualify, participants need to have had either a single or multiple intrauterine pregnancies, been monitored at participating sites, and gestational age up to 16-6/7 weeks* inclusively; additionally they must also sign up for the LEGACY Biobank program. *We aspire to recruit subjects below 12 weeks of gestation but are willing accept those under or equal 16-6/7 weeks as well."

Answered by AI

Are recruitment efforts for this clinical trial still ongoing?

"Indeed, the information on clinicaltrials.gov indicates that this research endeavour is actively recruiting participants. It was initially posted on May 28th 2018 and has been recently revised on June 23rd 2022. 80 individuals are required to be enrolled between one medical facility."

Answered by AI

Are geriatric individuals excluded from the criteria for this research?

"As per the eligibility criteria, this medical trial is open to any patients aged between 18 and 45. There are separate clinical trials for minors under 18 and seniors over 65 years of age with a total of 81 such studies being carried out in parallel."

Answered by AI

Recent research and studies

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Statistics Notes: The Use of Transformation When Comparing Two Means

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.

Hypertension in PregnancyJournal

Factors Associated with Patient Understanding of Preeclampsia

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.

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Assessing Disease Activity in SLE Patients During Pregnancy

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.

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