Clinical trial NCT05756244: PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism
Official title: A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Venous Thromboembolism
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 825
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant individuals on anticoagulation for VTE-related indications

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.

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.

Primary outcomes:
measure: Incidence of MB and CRNMB
timeFrame: Delivery up to 6 weeks postpartum
Secondary outcomes:
measure: Practice Patterns
timeFrame: Prior to delivery and following delivery
measure: MB and CRNMB incidence in the immediate and 6 W postpartum period
timeFrame: Within 24 hours of delivery and up to 6 weeks postpartum
measure: MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption
timeFrame: 6 weeks postpartum
measure: Incidence of VTE
timeFrame: Delivery to 6 weeks postpartum
measure: Wound Hematoma
timeFrame: Delivery to 6 weeks postpartum
measure: Anti-Xa levels
timeFrame: Delivery
measure: Hemoglobin Levels around Delivery
timeFrame: Before and after delivery
measure: Patient Experience
timeFrame: Delivery
measure: Healthcare Utilization
timeFrame: Before and after delivery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: BC Women's Hospital and Health Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Saint-Etienne
country: France
facility: Le Centre Hospitalier Universitaire of Saint-Etienne
Study officials:
affiliation: University of Calgary
name: Leslie Skeith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Isabelle Malhamé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Kinga Malinowski, MD
role: PRINCIPAL_INVESTIGATOR
References: