PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism (PREP and GO)

University of Calgary

Status: Enrolling

Conditions: Venous Thromboembolism; Pregnancy Related

Study type: Observational

Funder types: Other

Identifiers

NCT05756244

REB21-0795

Details and patient eligibility

About

The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.

Full 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.

Enrollment: 825 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.