PREP and GO: PRospective Evaluation of Peripartum Anticoagulation manaGement for thrOmboembolism

Sponsor

University of Calgary (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05756244

Collaborator

(none)

825

Enrollment

Location

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Venous Thromboembolism

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 Design

Study Type:

Observational

Anticipated Enrollment :

825 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2029

Anticipated Study Completion Date :

Dec 31, 2029

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
Wound Hematoma [Delivery to 6 weeks postpartum]
To estimate the incidence of wound hematoma complications 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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foothills Medical Centre	Calgary	Alberta	Canada	T2NT29

Sponsors and Collaborators

University of Calgary

Investigators

Principal Investigator: Leslie Skeith, MD, University of Calgary
Principal Investigator: Isabelle Malhamé, MD, McGill University
Principal Investigator: Kinga Malinowski, MD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Calgary

ClinicalTrials.gov Identifier:

NCT05756244

Other Study ID Numbers:

REB21-0795

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 6, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Study Results

No Results Posted as of Mar 6, 2023