NCT05756244 PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism
| NCT ID | NCT05756244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Pregnancy Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 825 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 825 participants in total. It began in 2023-04-04 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: 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.
Contact & Investigator
Leslie Skeith, MD
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT05756244 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05756244 currently recruiting?
Yes, NCT05756244 is actively recruiting participants. Contact the research team at jbaxter@ucalgary.ca for enrollment information.
Where is the NCT05756244 trial being conducted?
This trial is being conducted at Durham, United States, Calgary, Canada, Edmonton, Canada, Vancouver, Canada and 10 additional locations.
Who is sponsoring the NCT05756244 clinical trial?
NCT05756244 is sponsored by University of Calgary. The principal investigator is Leslie Skeith, MD at University of Calgary. The trial plans to enroll 825 participants.