NCT00356434

A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population

Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The researchers at Johns Hopkins University believe that the foot pump will be superior to sequential compression devices in comfort and patient compliance which may increase provider efforts to prevent deep vein thrombosis (DVT) in pregnancy.

Detailed description

The investigators will be comparing sequential compression devices (SCDs) to foot pumps to determine if foot pumps will be better tolerated by obstetric patients, both antepartum and intrapartum. Patients in whom thromboembolic prophylaxis is deemed necessary and ordered by the treating physician, who agree to participate in the study will be randomly assigned to receive SCDs or the foot pump as part of their thromboembolic prophylaxis regimen. The investigators will administer a questionnaire to assess patients' satisfaction and comfort with each device and they will be asked to complete a log of hours they wore their assigned device for a 7 day period (or as long as they are prescribed). Random spot checks to verify compliance will be performed.

Conditions

• Thrombophilia

Interventions

Type	Name	Description
DEVICE	Kendall A-V foot impulse pump, model 6060	Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use
DEVICE	Kendall sequential compression device, model 9525	Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2006-07-26
• Last updated: 2017-08-18
• Results posted: 2017-08-18

Locations

2 sites across 1 country: United States