NCT03749044Completed
ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies
Aspirin Patterns of Use and Adherence for Prevention of Preeclampsia in SLE Pregnancies
Source: ClinicalTrials.gov · Last updated 13 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 23 Oct 2018
- Start date
- 28 May 2018
- Primary completion date
- 11 Mar 2024
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- NCT number
- NCT03749044
What you commit to
- Study type: Interventional
- Participants enrolled: 73
- From 28 May 2018 to the primary completion date, 11 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Women who cannot provide informed consent due to severe illness;
Age
- Gestational age at 17 weeks and above
- Under the age of 18 and over the age of 45;
Other
- 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;
- 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 are cognitively impaired or incapable of understanding the text written on the consent form;
- Men are not eligible for this study.
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.