NCT04153760

Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Venous Thromboembolism
• Postpartum Period
• Aspirin

Interventions

Type	Name	Description
DRUG	Aspirin 81 mg	Aspirin 81 mg p.o. daily
DRUG	Placebo	Placebo p.o. daily

Timeline

• Start date: 2020-10-07
• Primary completion: 2023-09-05
• Completion: 2023-09-05
• First posted: 2019-11-06
• Last updated: 2023-09-13

Locations

7 sites across 4 countries: Canada, France, Ireland, Netherlands