PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

Study Overview
=================
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.

Official Title
-----------------
A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes

Conditions
-----------------
Pregnancy Related, Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
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: Objectively confirmed VTE (DVT, superficial vein thrombosis [SVT], PE or unusual site thrombosis) diagnosed during the current pregnancy; Objectively confirmed VTE diagnosed in a prior pregnancy; Objectively confirmed VTE diagnosed when not pregnant; 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |