PREP and GO Study: PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism
Summary
Pregnancy increases the risk of blood clots in the leg veins (deep vein thrombosis) and lungs (pulmonary embolism). Injectable blood thinners called low-molecular-weight heparin (LMWH) may be prescribed during pregnancy to prevent or treat blood clots. This may include people who have a new or prior blood clot, or those who have strong risk factors for a blood clot.
This can create a challenge around labor and delivery, because staying on blood thinners can increase the risk of bleeding and affect the ability to get an epidural or spinal anesthetic for pain control. There are different approaches around the world for managing blood thinners around during labor and delivery. Generally, blood thinners are stopped before delivery to prevent bleeding and are restarted after delivery to prevent blood clots. Sometimes, a planned delivery called an induction of labor is recommended.
The safest time to stop and restart the blood thinners is not known and may influence being able to have a natural delivery or a planned delivery.
The purpose of this research study is to help give doctors and future pregnant patients more information about the safety of different approaches that are used to reduce the risk of blood clots in pregnancy and after delivery.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 60
Inclusion criteria:
1.18 years of age or older.
2. Needs anticoagulation (blood thinners) during pregnancy for a blood clot indication, including at least one of:
a) Blood clots in the legs, lungs or other locations diagnosed during the current pregnancy;
b) Blood clots in the legs, lungs or other locations diagnosed in a prior pregnancy;
c) Blood clots in the legs, lungs or other locations diagnosed when not pregnant;
d) Inherited or acquired blood clotting conditions requiring anticoagulation.
3. Receiving any dose or type of LMWH (injectable blood thinners) during pregnancy.
Exclusion criteria:
1. Anticoagulation (blood thinners) for another reason other than blood clot prevention or treatment. This includes being on blood thinners for a prosthetic heart valves, atrial fibrillation, prevention of pregnancy complications*
2. Unable or unwilling to provide informed consent.
3. Delivery at home or at a birthing centre.
*Participants can be included with a diagnosis of antiphospholipid syndrome (APS) or have antiphospholipid antibodies with or without a blood clot history.
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
If you are interested in being part of this study and you are pregnant and are on injectable blood thinners, please let your healthcare team know. You can also go to the website www.prepandgo.ca or email info@prepandgo.ca for more information.
Principal investigator:
Leslie Skeith
Clinical trial:
No
REB-ID:
REB21-0795