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The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.
The goal of this study is to provide quality data using standardized outcome definitions on postpartum bleeding events, venous thromboembolism (VTE) risk, delivery experience outcomes and health care utilization for intrapartum and postpartum anticoagulation management among pregnant individuals on low-molecular-weight heparin (LMWH) for prevention of treatment of VTE.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MB and CRNMB | To estimate the combined incidence of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) for the six most common antepartum strategies. | Delivery up to 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Practice Patterns | To determine the practice patterns of intrapartum and postpartum anticoagulant management for pregnant individuals on LMWH for VTE indications across participating centres. | Prior to delivery and following delivery |
| MB and CRNMB incidence in the immediate and 6 W postpartum period |
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Inclusion Criteria:
18 years of age or older
Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of:
Receiving any dose or type of LMWH during the antepartum period
Exclusion Criteria:
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Pregnant individuals on anticoagulation for VTE-related indications
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jill Baxter, BSc | Contact | 403-220-7103 | jbaxter@ucalgary.ca | |
| Leslie Skeith, MD | Contact | 403-944-5246 | laskeith@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Leslie Skeith, MD | University of Calgary | Principal Investigator |
| Isabelle Malhamé, MD | McGill University | Principal Investigator |
| Kinga Malinowski, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
Please contact study PI for requests.
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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To estimate the incidence of MB and CRNMB in the immediate postpartum period (within 24 hours) and up to 6 weeks postpartum for each antepartum strategy. |
| Within 24 hours of delivery and up to 6 weeks postpartum |
| MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption | To estimate the incidence of MB and CRNMB up to 6 weeks postpartum, based on the time and dose of postpartum anticoagulation resumption. | 6 weeks postpartum |
| Incidence of VTE | To estimate the incidence of symptomatic objectively confirmed VTE up to 6 weeks postpartum for each antepartum strategy. | Delivery to 6 weeks postpartum |
| Wound Hematoma | To estimate the incidence of wound hematoma complications up to 6 weeks postpartum for each antepartum strategy. | Delivery to 6 weeks postpartum |
| Anti-Xa levels | To compare anti-Xa levels on admission for delivery in individuals with and without immediate postpartum MB and CRNMB. | Delivery |
| Hemoglobin Levels around Delivery | To compare a change in hemoglobin levels before and after delivery in individuals with and without immediate postpartum MB and CRNMB. | Before and after delivery |
| Patient Experience | To describe delivery experience outcomes including neuraxial anesthesia (eligible vs. preferred vs. actual), patient satisfaction, and patient choice relating to delivery management options. | Delivery |
| Healthcare Utilization | To quantify healthcare utilization including hospital length of stay, postpartum length of stay, repeat procedures and induction of labor resource utilization. | Before and after delivery |
| University of Toronto |
| Principal Investigator |
| Foothills Medical Centre | Recruiting | Calgary | Alberta | T2N 2T9 | Canada |
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| Royal Alexandra Hospital | Recruiting | Edmonton | Alberta | T5H 3V9 | Canada |
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| BC Women's Hospital and Health Centre | Recruiting | Vancouver | British Columbia | V6H 3N1 | Canada |
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| St. Boniface Hospital | Recruiting | Winnipeg | Manitoba | R2H 2A6 | Canada |
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| McMaster University Medical Centre | Recruiting | Hamilton | Ontario | L8N 3Z5 | Canada |
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| The Ottawa Hospital - General Campus | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| Montfort Hospital | Recruiting | Ottawa | Ontario | K1K 0T2 | Canada |
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| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| CHU Sainte-Justine | Recruiting | Montreal | Quebec | H3T 1C5 | Canada |
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| The Sir Mortimer B. Davis Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| Le Centre Hospitalier Universitaire of Saint-Etienne | Recruiting | Saint-Etienne | France |
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| Hopitaux universitaires de Geneve | Recruiting | Geneva | 1205 | Switzerland |
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