PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Venous Thromboembolism. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Denmark, France, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes
Overview
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.
Primary outcome measures
- Incidence of MB and CRNMB [Time frame: Delivery up to 6 weeks postpartum]
Secondary outcome measures (9)
- Practice Patterns [Time frame: Prior to delivery and following delivery]
- MB and CRNMB incidence in the immediate and 6 W postpartum period [Time frame: Within 24 hours of delivery and up to 6 weeks postpartum]
- MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption [Time frame: 6 weeks postpartum]
- Incidence of VTE [Time frame: Delivery to 6 weeks postpartum]
- Wound Hematoma [Time frame: Delivery to 6 weeks postpartum]
- Anti-Xa levels [Time frame: Delivery]
- Hemoglobin Levels around Delivery [Time frame: Before and after delivery]
- Patient Experience [Time frame: Delivery]
- Healthcare Utilization [Time frame: Before and after delivery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 10 centers
- Foothills Medical Centre — Calgary
- Royal Alexandra Hospital — Edmonton
- BC Women's Hospital and Health Centre — Vancouver
- St. Boniface Hospital — Winnipeg
- McMaster University Medical Centre — Hamilton
- The Ottawa Hospital - General Campus — Ottawa
- Montfort Hospital — Ottawa
- Mount Sinai Hospital — Toronto
- … and 2 more centers
United States · 1 center
- Duke University Hospital — Durham
Denmark · 1 center
- Aarhus University Hospital — Aarhus
France · 1 center
- Le Centre Hospitalier Universitaire of Saint-Etienne — Saint-Etienne
Switzerland · 1 center
- Hopitaux universitaires de Geneve — Geneva
Identifiers
NCT: NCT05756244 · REB21-0795