Venous Thromboembolism study: Aspirin vs Low-molecular-weight heparin
Official title The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
ClinicalTrials.gov ID: NCT06494878
What this study is testing
What is Aspirin?
This is an investigational low-dose daily pill being studied to see if it prevents blood clots after childbirth. It is designed to reduce the ability of blood cells to stick together and form clots.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if taking low-dose aspirin is just as good as standard heparin injections for preventing blood clots.
- Who it's for
- People who have just given birth and have risk factors for blood clots.
- What's involved
- Participants will take either daily aspirin or standard heparin injections for six weeks after delivery.
- Time commitment
- The study lasts six weeks after delivery, requiring daily medication and follow-up visits.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Known inherited thrombophilia diagnosed prior to enrolment, regardless of family history of VTE: i. Heterozygous factor V Leiden, or ii.
- Pre-pregnancy BMI ≥30 kg/m²
- Smoking in the current pregnancy or within 3 months prior to pregnancy
- Previous clinical history of superficial vein thrombosis
- Preeclampsia
You likely can't join if
- More than 48 hours since delivery at the time of randomization
- Received more than 1 dose of LMWH since delivery
- Documented history of provoked or unprovoked VTE
- Mechanical heart valve(s)
- Known antiphospholipid syndrome (APS)
- Known high-risk inherited thrombophilia i) Antithrombin deficiency, or ii) Homozygous factor V Leiden, or iii) Homozygous prothrombin gene mutation...
See the full eligibility criteria
- Known inherited thrombophilia diagnosed prior to enrolment, regardless of family history of VTE: i. Heterozygous factor V Leiden, or ii. Heterozygous prothrombin gene variant, or iii. Protein C deficiency, or iv.
- Pre-pregnancy BMI ≥30 kg/m²
- Smoking in the current pregnancy or within 3 months prior to pregnancy
- Previous clinical history of superficial vein thrombosis
- Preeclampsia
- Current pregnancy ending in stillbirth (pregnancy loss \>20 weeks gestation)
- Unplanned cesarean delivery (unplanned = not a scheduled cesarean delivery)
- Small-for-gestational-age infant at time of delivery (\<3rd percentile adjusted for gestational age and sex)
- Peripartum or postpartum infection (symptoms/signs of infection and documented fever and laboratory evidence of infection with positive blood cultures or an elevated white blood cell count based on local laboratory...
- Postpartum hemorrhage (≥1000 mL of blood loss, regardless of delivery mode)
- More than 48 hours since delivery at the time of randomization
- Received more than 1 dose of LMWH since delivery
- Documented history of provoked or unprovoked VTE
- Mechanical heart valve(s)
- Known antiphospholipid syndrome (APS)
- Known high-risk inherited thrombophilia i) Antithrombin deficiency, or ii) Homozygous factor V Leiden, or iii) Homozygous prothrombin gene mutation, or iv) More than 1 thrombophilia: any combination of 2 or more: factor...
- Documented history of myocardial infarction
- Documented history of ischemic stroke or transient ischemic attack (TIA)
- Active bleeding, excluding normal vaginal bleeding, at the time of randomization
- Known medical condition as judged by their physician and/or local investigator to be a contraindication to ASA or LMWH including known ASA or LMWH allergy
- \<18 years of age
- Unable or declined consent
The study team makes the final eligibility decision.
Where it is enrolling
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Calgary, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.