The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (14)
Facility
City
Region
Status
Duke University Hospital
Durham
North Carolina
Recruiting
Foothills Medical Centre
Calgary
Alberta
Recruiting
Royal Alexandra Hospital
Edmonton
Alberta
Recruiting
BC Women's Hospital and Health Centre
Vancouver
British Columbia
Recruiting
St. Boniface Hospital
Winnipeg
Manitoba
Recruiting
McMaster University Medical Centre
Hamilton
Ontario
Recruiting
The Ottawa Hospital - General Campus
Ottawa
Ontario
Recruiting
Montfort Hospital
Ottawa
Ontario
Recruiting
Mount Sinai Hospital
Toronto
Ontario
Recruiting
CHU Sainte-Justine
Montreal
Quebec
Recruiting
The Sir Mortimer B. Davis Jewish General Hospital
Montreal
Quebec
Recruiting
Aarhus University Hospital
Aarhus
Denmark
Recruiting
Le Centre Hospitalier Universitaire of Saint-Etienne
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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