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| Name | Class |
|---|---|
| St. Joseph's Healthcare Hamilton | OTHER |
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Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with prior VTE are based primarily on expert opinion and the optimal clinical management strategy remains unclear.
This multicentre, prospective cohort study aims to test the following hypotheses:
All study patients will receive 6 weeks of postpartum prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior VTE minor transient risk factor | Pregnant women with a single prior VTE episode that was either unprovoked or associated with a minor transient risk factor - Prophylaxis with fixed-dose LMWH | ||
| Prior VTE major transient risk factor | Pregnant women with a single prior VTE episode that was provoked by a major transient risk factor - Surveillance |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic venous thromboembolism | Symptomatic objectively confirmed recurrent VTE, including proximal DVT, non-fatal PE, and fatal PE during antepartum period | antepartum period (expected average 7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic recurrent venous thromboembolism | Symptomatic recurrent VTE antepartum and within first 3 months postpartum | antepartum period (expected average 7 months) and first 3 months postpartum |
| Symptomatic recurrent pulmonary embolism |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive pregnant women with prior VTE diagnosed with accurate testing.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon M Bates, MD | Contact | 905-521-2100 | 73928 | batesm@mcmaster.ca |
| Nancy Lloyd, MSc | Contact | 905-522-1155 | 33269 | lloydn@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Shannon M Bates, MD | McMaster University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11078768 | Background | Brill-Edwards P, Ginsberg JS, Gent M, Hirsh J, Burrows R, Kearon C, Geerts W, Kovacs M, Weitz JI, Robinson KS, Whittom R, Couture G; Recurrence of Clot in This Pregnancy Study Group. Safety of withholding heparin in pregnant women with a history of venous thromboembolism. Recurrence of Clot in This Pregnancy Study Group. N Engl J Med. 2000 Nov 16;343(20):1439-44. doi: 10.1056/NEJM200011163432002. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D013923 | Thromboembolism |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Symptomatic objectively confirmed recurrent PE antepartum and within first 3 months postpartum
| antepartum period (expected average 7 months) and first 3 months postpartum |
| Thrombocytopenia or heparin-induced thrombocytopenia (HIT) | Thrombocytopenia or HIT during antepartum period | antepartum period (expected average 7 months) |
| Symptomatic osteoporosis | Symptomatic osteoporosis antepartum and within first 3 months postpartum | antepartum period (expected average 7 months) and first 3 months postpartum |
| Other complications | Other complications sufficient to stop treatment (e.g., local and systemic reactions) antepartum and within first 3 months postpartum | antepartum (expected average 7 months) and within first 3 months postpartum |
| Pregnancy complications and outcomes | Pregnancy complications and outcomes including fetal death, pre-eclampsia, toxemia, intrauterine growth restriction, prematurity during antepartum period | antepartum period (expected average 7 months) |
| Fetal anomalies | Fetal anomalies | antepartum (expected average 7 months) and during first 3 months postpartum |
| Major and minor bleeding | Major and minor bleeding | antepartum (expected average 7 months) |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
|
| D000091642 | Urogenital Diseases |