Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494878
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-12
Brief Title:
The PARTUM Trial Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The PARTUM Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar non-inferior to usual care low-molecular-weight heparin injections to prevent venous thromboembolism VTE blood clots in the legs or lungs for postpartum individuals with VTE risk factors
Detailed Description:
The PARTUM trial design is a Prospective Randomized Open Blinded End-point PROBE non-inferiority trial Participants with risk factors for venous thromboembolism VTE as defined by the inclusion criteria will be identified during pregnancy labor and delivery and up to 48 hours after delivery
Eligible and consenting participants will be randomly assigned to one of two study arms Low-dose aspirin 75-100mg according to country availability daily for 42 days post-randomization or a usual care site-specific low-molecular-weight-heparin LMWH regimen with the dose and duration of LMWH determined by the participants healthcare provider
Follow-up will occur at 6 weeks and 90 days post-randomization
Eligible and consenting participants will be randomly assigned to one of two study arms Low-dose aspirin 75-100mg according to country availability daily for 42 days post-randomization or a usual care site-specific low-molecular-weight-heparin LMWH regimen with the dose and duration of LMWH determined by the participants healthcare provider
Follow-up will occur at 6 weeks and 90 days post-randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None