PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

Pregnancy Related Clinical Trial

— PREP and GO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756244
• Other study ID #: REB21-0795
• Status: Recruiting
• Start date: April 4, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2024
• Source: University of Calgary
• Contact: Jill Baxter, BSc
• Phone: 403-220-7103
• Email: jbaxter[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 825
• Est. completion date: December 31, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

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