The PARTUM trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Summary
Some people are at risk for developing blood clots in the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE)) after they deliver a baby (postpartum). These are both serious health conditions and a PE can be life threatening. The risk of blood clots is highest in the first 6 weeks after delivery. While we know the risk factors for getting a blood clot after delivery, we still don't know what the best way is to prevent blood clots in the legs and lungs during this time.
Injectable blood thinners called low-molecular-weight-heparin (LMWH) are often given to people who have risk factors for blood clots after delivering their baby to help prevent blood clots. There are not many research studies to guide practice, so there is variation in whether someone gets LMWH injections and for how long after delivery.
We are researching another option of taking aspirin daily instead of injectable blood thinners to safely prevent blood clots after delivery. Aspirin is commonly used to prevent blood clots in people after hip and knee surgery. Aspirin and LMWH are both safe with breastfeeding, and aspirin is a pill instead of an injection.
The purpose of this research study is to determine if taking aspirin daily for 6 weeks after delivery is similar to the usual care of taking an injectable blood thinner (LMWH) for the prevention of blood clots. This will allow us to better care for postpartum women who are at risk of blood clots.
To do this, participants in this study will be randomized to either take aspirin 81 mg daily for 6 weeks or to take usual care with LMWH injections daily based on their doctor’s recommendation. Follow-up will occur at 6 weeks and 90 days after delivery, and will be by an electronic questionnaire sent by email or text message. A telephone call or in-person visit can be an option if needed.
Eligibility
Eligible ages: 18 to 60
Inclusion criteria:
You may be approached about the PARTUM trial if you are 18 or older and have risk factors for blood clots in the legs or lungs. These risk factors include:
One or more risk factors:
1) An inherited thrombophilia (genetic blood clotting condition) - e.g. factor V Leiden mutation
2) On strict bedrest for a week or more at any time during your pregnancy
AND/OR
Two or more risk factors:
1) BMI before pregnancy that is greater or equal to 30 kg/m²
2) Smoking before or during pregnancy
3) History of a superficial vein thrombosis (blood clot in the superficial veins)
4) You develop preeclampsia (high blood pressure and protein in your urine)
5) Your current pregnancy ends in a pregnancy loss (>20 weeks gestation)
6) You have an unplanned cesarean section
7) You have a small for gestational age infant
8) You have a postpartum infection
9) You have a postpartum hemorrhage
Exclusion criteria:
If your doctor thinks you need aspirin or injectable low-molecular-weight heparin blood thinners for other reasons, or you have a a reason not to take aspirin or injectable blood thinners, then you will not be eligible to participate in this trial. This may include the following:
1. It has been more than 48 hours since you delivered your baby
2. You have received more than 1 dose of LMWH injections since delivery
3. Your doctor decides you need LMWH injections for another reason (e.g. past history of blood clots)
4. Your doctor decides that you need aspirin for another reason (e.g. history of heart attack or stroke)
5. You have active bleeding, excluding normal vaginal bleeding, postpartum
6. You have another medical condition where it is not safe to take aspirin or LMWH injections, including allergy to ASA or LMWH injections
7. You are less than 18 years of age
8. You are unable to or decline consent
Participate
Additional information
Contact information
Individuals who are interested in participating will be approached during clinic visits or at the time of labor and delivery. If you are potentially interested in participating or hearing more about the study, then please visit partumtrial.ca or contact us below by email, text message or phone call.
Principal investigator:
Leslie Skeith
Clinical trial:
Yes
REB-ID:
REB24-0317
External links