Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)

NCT01357941 | Unknown DMC

• 1 other identifier: HHS130511
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 2

Brief Summary

Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with prior VTE are based primarily on expert opinion and the optimal clinical management strategy remains unclear. This multicentre, prospective cohort study aims to test the following hypotheses:

1. 1.Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe, convenient and associated with an acceptably low risk of recurrent VTE in women with a single prior episode of VTE that was either unprovoked or associated with a minor transient risk factor. (Moderate risk cohort)
2. 2.Withholding antepartum prophylaxis is safe (recurrence risk \<1%) in pregnant women with a single prior episode of VTE provoked by a major transient risk factor. (Low risk cohort)

Conditions

Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Keywords

venous thromboembolism; thromboembolism; deep vein thrombosis; pulmonary embolism; thromboprophylaxis; thrombosis; embolism and thrombosis; cardiovascular diseases; venous thrombosis; vascular diseases; anticoagulants; hematologic agents; cardiovascular agents; enoxaparin; dalteparin; tinzaparin; pregnancy complications

Outcome Measures

Primary Outcomes (1)

• Symptomatic venous thromboembolism

  Symptomatic objectively confirmed recurrent VTE, including proximal DVT, non-fatal PE, and fatal PE during antepartum period

  antepartum period (expected average 7 months)

Secondary Outcomes (8)

• Symptomatic recurrent venous thromboembolism

  antepartum period (expected average 7 months) and first 3 months postpartum

• Symptomatic recurrent pulmonary embolism

  antepartum period (expected average 7 months) and first 3 months postpartum

• Thrombocytopenia or heparin-induced thrombocytopenia (HIT)

  antepartum period (expected average 7 months)

• Symptomatic osteoporosis

  antepartum period (expected average 7 months) and first 3 months postpartum

• Other complications

  antepartum (expected average 7 months) and within first 3 months postpartum

Study Arms (2)

Prior VTE minor transient risk factor

Pregnant women with a single prior VTE episode that was either unprovoked or associated with a minor transient risk factor - Prophylaxis with fixed-dose LMWH

Prior VTE major transient risk factor

Pregnant women with a single prior VTE episode that was provoked by a major transient risk factor - Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive pregnant women with prior VTE diagnosed with accurate testing.

You may qualify if:

• Confirmed pregnancy (positive serum or urine)
• At least 18 years of age
• History of one prior episode of VTE consisting of DVT (diagnosed by compression ultrasonography \[CUS\] or venography) and/or PE (diagnosed by ventilation-perfusion \[V/Q\] lung scintigraphy, computed tomographic pulmonary angiography \[CTPA\], or traditional pulmonary angiography)

You may not qualify if:

• Ongoing need for therapeutic anticoagulation for prevention or treatment of cardioembolic stroke
• Known high-risk thrombophilia (specifically antithrombin deficiency, protein S deficiency, protein C deficiency, homozygosity for the factor V Leiden or prothrombin G20210A mutations, antiphospholipid antibody or compound abnormalities)
• VTE within 3 months of the current pregnancy
• Clinical risk factor for initial episode of VTE, if present, not resolved (excluding pregnancy)
• Known contraindication to anticoagulation (including active, uncontrolled bleeding or major bleed within the previous 4 weeks)
• For patients with prior unprovoked VTE, contraindication to LMWH (including allergy, HIT, impaired renal function, osteoporosis)
• Geographic or social factors precluding follow-up
• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Brill-Edwards P, Ginsberg JS, Gent M, Hirsh J, Burrows R, Kearon C, Geerts W, Kovacs M, Weitz JI, Robinson KS, Whittom R, Couture G; Recurrence of Clot in This Pregnancy Study Group. Safety of withholding heparin in pregnant women with a history of venous thromboembolism. Recurrence of Clot in This Pregnancy Study Group. N Engl J Med. 2000 Nov 16;343(20):1439-44. doi: 10.1056/NEJM200011163432002.

  PMID: 11078768 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Thromboembolism; Thrombosis; Embolism and Thrombosis; Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Shannon M Bates, MD

  McMaster University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon M Bates, MD

CONTACT

905-521-2100; batesm@mcmaster.ca

Nancy Lloyd, MSc

CONTACT

905-522-1155; lloydn@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: June 3, 2011

Record last verified: 2011-06

Locations

CA (2)