The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.
The purpose of the pilot PARTUM trial is to determine whether it is feasible to conduct a larger randomized controlled trial to determine whether low-dose aspirin is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo. Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of aspirin 81 mg versus placebo, the investigators first need to determine if it is possible to recruit enough women. If the pilot trial is successful and there are no major changes to the study design, then the secondary clinical outcomes collected in the pilot trial will be used in the analysis of the full multicenter trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
257
Aspirin 81 mg p.o. daily
Placebo p.o. daily
Foothills Medical Centre
Calgary, Alberta, Canada
British Columbia Women's Hospital & Health Centre
Vancouver, British Columbia, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Recruitment Rate
Mean recruitment rate per center per month
Time frame: 6 months
Consent Rate
Proportion of eligible subjects who provide consent
Time frame: 6 months
Withdrawals/Loss to Follow-up
Proportion of withdrawals/loss to follow-up among participants
Time frame: 9 months
Study Drug Compliance
Level of compliance with study drug through participant recall and medication diary
Time frame: 6 months
Time Required to Obtain Site Institutional Approvals
Proportion of sites requiring \>18 months to obtain all required approvals/contracts from time of delivery of all study documents.
Time frame: 24 months
VTE Event Rate
A more precise estimate of the VTE event rate
Time frame: 6 months
Bleeding Event Rate
A more precise estimate of the major and clinically relevant non-major bleeding event rate
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Rotunda Hospital
Dublin, Ireland
The Amsterdam Medical Centre
Amsterdam, North Holland, Netherlands