NCT01357941

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 203 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Deep Vein Thrombosis
• Pulmonary Embolism

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2014-09-01
• First posted: 2011-05-23
• Last updated: 2011-06-03

Locations

2 sites across 1 country: Canada