Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05756244

PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pregnancy Related Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of MB and CRNMB

    Time frame: 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 outcomes

  1. Practice Patterns

    Time frame: 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.

  2. 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

    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.

  3. MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption

    Time frame: 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.

  4. Incidence of VTE

    Time frame: Delivery to 6 weeks postpartum

    To estimate the incidence of symptomatic objectively confirmed VTE up to 6 weeks postpartum for each antepartum strategy.

  5. Wound Hematoma

    Time frame: Delivery to 6 weeks postpartum

    To estimate the incidence of wound hematoma complications up to 6 weeks postpartum for each antepartum strategy.

  6. Anti-Xa levels

    Time frame: Delivery

    To compare anti-Xa levels on admission for delivery in individuals with and without immediate postpartum MB and CRNMB.

  7. Hemoglobin Levels around Delivery

    Time frame: 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.

  8. Patient Experience

    Time frame: Delivery

    To describe delivery experience outcomes including neuraxial anesthesia (eligible vs. preferred vs. actual), patient satisfaction, and patient choice relating to delivery management options.

  9. Healthcare Utilization

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jill Baxter, BSc

CONTACT

[email protected]

403-220-7103

Leslie Skeith, MD

CONTACT

[email protected]

403-944-5246

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes

Acronym: PREP and GO

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 6, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.