Pregnancy Related, Venous Thromboembolism
Conditions
Brief summary
The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.
Detailed description
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.
Interventions
None listed
Sponsors
University of Calgary
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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: 1. Objectively confirmed VTE (DVT, superficial vein thrombosis \[SVT\], PE or unusual site thrombosis) diagnosed during the current pregnancy; 2. Objectively confirmed VTE diagnosed in a prior pregnancy; 3. Objectively confirmed VTE diagnosed when not pregnant; 4. Inherited or acquired thrombophilia requiring anticoagulation. * Receiving any dose or type of LMWH during the antepartum period
Exclusion criteria
* Anticoagulation for a non-VTE indication, including prosthetic heart valves, atrial fibrillation, prevention of placenta-mediated pregnancy complications, or prevention of recurrent pregnancy loss (participants can be included with a diagnosis of antiphospholipid syndrome (APS) with or without thrombotic events) * Unable to provide or declined consent. * Home or birthing centre planned delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MB and CRNMB | Delivery up to 6 weeks postpartum | To estimate the combined incidence of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) for the six most common antepartum strategies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MB and CRNMB incidence in the immediate and 6 W postpartum period | Within 24 hours of delivery and up to 6 weeks postpartum | 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. |
| MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption | 6 weeks postpartum | To estimate the incidence of MB and CRNMB up to 6 weeks postpartum, based on the time and dose of postpartum anticoagulation resumption. |
| Incidence of VTE | Delivery to 6 weeks postpartum | To estimate the incidence of symptomatic objectively confirmed VTE up to 6 weeks postpartum for each antepartum strategy. |
| Wound Hematoma | Delivery to 6 weeks postpartum | To estimate the incidence of wound hematoma complications up to 6 weeks postpartum for each antepartum strategy. |
| Practice Patterns | Prior to delivery and following delivery | To determine the practice patterns of intrapartum and postpartum anticoagulant management for pregnant individuals on LMWH for VTE indications across participating centres. |
| Hemoglobin Levels around Delivery | Before and after delivery | To compare a change in hemoglobin levels before and after delivery in individuals with and without immediate postpartum MB and CRNMB. |
| Patient Experience | Delivery | To describe delivery experience outcomes including neuraxial anesthesia (eligible vs. preferred vs. actual), patient satisfaction, and patient choice relating to delivery management options. |
| Healthcare Utilization | Before and after delivery | To quantify healthcare utilization including hospital length of stay, postpartum length of stay, repeat procedures and induction of labor resource utilization. |
| Anti-Xa levels | Delivery | To compare anti-Xa levels on admission for delivery in individuals with and without immediate postpartum MB and CRNMB. |
Countries
Canada, Denmark, France, Switzerland, United States
Contacts
Primary ContactJill Baxter, BSc
Backup ContactLeslie Skeith, MD
Outcome results
None listed