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

Pulmonary Embolism Clinical Trial

— ROCITP2  

Official title:

Prospective Study Assessing the Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01357941
• Other study ID #: HHS130511
• Status: Not yet recruiting
• Phase: N/A
• First received: May 19, 2011
• Last updated: June 2, 2011
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: June 2011
• Source: Hamilton Health Sciences Corporation
• Contact: Shannon M Bates, MD
• Phone: 905-521-2100
• Email: batesm[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Observational

Clinical Trial 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. 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. 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)

All study patients will receive 6 weeks of postpartum prophylaxis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 203
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Symptomatic recurrent venous thromboembolism	Symptomatic recurrent VTE antepartum and within first 3 months postpartum	antepartum period (expected average 7 months) and first 3 months postpartum	Yes
Secondary	Symptomatic recurrent pulmonary embolism	Symptomatic objectively confirmed recurrent PE antepartum and within first 3 months postpartum	antepartum period (expected average 7 months) and first 3 months postpartum	Yes
Secondary	Thrombocytopenia or heparin-induced thrombocytopenia (HIT)	Thrombocytopenia or HIT during antepartum period	antepartum period (expected average 7 months)	Yes
Secondary	Symptomatic osteoporosis	Symptomatic osteoporosis antepartum and within first 3 months postpartum	antepartum period (expected average 7 months) and first 3 months postpartum	Yes
Secondary	Other complications	Other complications sufficient to stop treatment (e.g., local and systemic reactions) antepartum and within first 3 months postpartum	antepartum (expected average 7 months) and within first 3 months postpartum	Yes
Secondary	Pregnancy complications and outcomes	Pregnancy complications and outcomes including fetal death, pre-eclampsia, toxemia, intrauterine growth restriction, prematurity during antepartum period	antepartum period (expected average 7 months)	Yes
Secondary	Fetal anomalies	Fetal anomalies	antepartum (expected average 7 months) and during first 3 months postpartum	No
Secondary	Major and minor bleeding	Major and minor bleeding	antepartum (expected average 7 months)	Yes