ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

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

Interventions

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.

Sponsors & Collaborators

• University of Calgary

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Laval University

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Evelyne Vinet, MD/PhD · Research Institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-28

Primary Completion

2024-03-11

Completion

2024-03-11

Countries

• Canada

Study Locations