The PARTUM trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Summary
Some women are at risk for developing blood clots in the legs or lungs (thrombosis) after they deliver a baby (postpartum). A blood clot can form in the lungs , which can be serious. The risk of blood clots is highest in the first 6 weeks after delivery. While we know what the risk factors are for getting a blood clot after delivery, we still don’t know what the best way is to prevent blood clots.
Previous research studies (trials) tried to see if using daily injectable blood thinners after delivery could prevent blood clots. These trials were not successful because taking daily injectable blood thinners at home was not very popular. Many women who deliver babies and have modest risk factors for blood clots may be given injectable blood thinners while they are in hospital, but they usually do not go home on injectable blood thinners.
The PARTUM trial asks if aspirin is a safe and effective option for preventing blood clots in women who have risk factors for blood clots after delivery. Aspirin helps to prevent blood clots in people after hip and knee surgery. It is an attractive choice after delivery because it is safe with breastfeeding. We are studying whether aspirin will help to prevent blood clots in postpartum women who have risk factors for blood clots. This will allow us to better care for postpartum women who are at risk of blood clots.
Our pilot PARTUM trial is a research study for postpartum women who have additional risk factors for blood clots. Postpartum women will be randomly assigned to low dose aspirin or placebo pills daily for 6 weeks after delivery. The goal of this pilot study is to see if a larger international trial is possible, so we can determine if low dose aspirin can safely prevent blood clots in postpartum women who are at risk. We will collect information about blood clots and bleeding that will be used in our larger trial.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 60
Accepts healthy participants: Yes
Inclusion criteria:
You may be approached about the pilot PARTUM trial if you are 18 or older and have risk factors for blood clots. These risk factors include:
One or more risk factors:
1) An inherited blood clotting disorder (e.g. factor V Leiden mutation)
2) On bedrest for a week or more at any time during your pregnancy
Two or more risk factors:
1) BMI before pregnancy that is greater or equal to 30 kg/m2
2) Smoking before pregnancy
3) History of a superficial vein thrombosis (blood clot in the superficial veins)
4) You develop pre-eclampsia (high blood pressure and protein in your urine)
5) You have an unplanned cesarean section
6) You have a small for gestational age infant
7) You have a postpartum hemorrhage
8) You have a postpartum infection
9) Your current pregnancy ends in a pregnancy loss (>20 weeks gestation)
Exclusion criteria:
If your doctor thinks you are at a high risk for developing blood clots and they recommend that you go home on injectable blood thinners, or you need aspirin for other reasons, then you will not be eligible to participate in this trial. This may include having:
1. History of blood clots in the legs (DVT) or lungs (PE)
2. Having a stronger inherited blood clotting condition
3. Antiphospholipid syndrome
4. History of a heart attack
5. History of a stroke or transient ischemic attack (mini stroke)
6. A reason not to take aspirin, such as active bleeding, low blood counts, a history of a stomach ulcer, or an allergy to aspirin
7. If you are postpartum and have taken more than 2 doses of injectable blood thinners after delivery
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
Women 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 the partumtrial.ca or contact us below.
Principal investigator:
Leslie Skeith
Clinical trial:
Yes
REB-ID:
REB19-1237