PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

Recruiting

• Conditions: Pregnancy Related; Venous Thromboembolism

• Registration Number: NCT05756244
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-06
• Study Start: 2023-04-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03
• Primary Completion: 2029-06-30
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 825

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Wound Hematoma	Delivery to 6 weeks postpartum	To estimate the incidence of wound hematoma complications up to 6 weeks postpartum for each antepartum strategy.
Practice Patterns	Prior to delivery and following delivery	To determine the practice patterns of intrapartum and postpartum anticoagulant management for pregnant individuals on LMWH for VTE indications across participating centres.
MB and CRNMB incidence in the immediate and 6 W postpartum period	Within 24 hours of delivery and up to 6 weeks postpartum	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.
Incidence of VTE	Delivery to 6 weeks postpartum	To estimate the incidence of symptomatic objectively confirmed VTE up to 6 weeks postpartum for each antepartum strategy.
Anti-Xa levels	Delivery	To compare anti-Xa levels on admission for delivery in individuals with and without immediate postpartum MB and CRNMB.
Patient Experience	Delivery	To describe delivery experience outcomes including neuraxial anesthesia (eligible vs. preferred vs. actual), patient satisfaction, and patient choice relating to delivery management options.
Healthcare Utilization	Before and after delivery	To quantify healthcare utilization including hospital length of stay, postpartum length of stay, repeat procedures and induction of labor resource utilization.
MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption	6 weeks postpartum	To estimate the incidence of MB and CRNMB up to 6 weeks postpartum, based on the time and dose of postpartum anticoagulation resumption.
Hemoglobin Levels around Delivery	Before and after delivery	To compare a change in hemoglobin levels before and after delivery in individuals with and without immediate postpartum MB and CRNMB.

Trial Locations

Locations (7)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

BC Women's Hospital and Health Centre; 🇨🇦 Vancouver, British Columbia, Canada

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Le Centre Hospitalier Universitaire of Saint-Etienne; 🇫🇷 Saint-Etienne, France