Status:

COMPLETED

ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

Lead Sponsor:

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

Collaborating Sponsors:

University of Calgary

University of Toronto

Conditions:

Pre-Eclampsia

Pregnancy Complications

Eligibility:

FEMALE

18-45 years

Phase:

NA

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 red...

Detailed Description

The goal is to help improve counselling and ASA adherence for preeclampsia prevention in pregnant women with SLE. This study could offer the ideal setting for the conduct of a future study assessing t...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • 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
  • Exclusion Criteria
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 28 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 11 2024

    Estimated Enrollment :

    73 Patients enrolled

    Trial Details

    Trial ID

    NCT03749044

    Start Date

    May 28 2018

    End Date

    March 11 2024

    Last Update

    March 13 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    McGill University Health Centre

    Montreal, Quebec, Canada, H4A 3S9