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

Johns Hopkins University

Status: Terminated

Conditions: Thrombophilia

Treatments: Device: Kendall sequential compression device, model 9525; Device: Kendall A-V foot impulse pump, model 6060

Study type: Interventional

Funder types: Other

Identifiers

NCT00356434

foot pump vs SCD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant
• Bedrest
• Thrombophilia
• Prescribed DVT prophylaxis

Exclusion criteria

• Active DVT

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

1

Active Comparator group

Description:

Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT

Treatment:

Device: Kendall A-V foot impulse pump, model 6060

2

Active Comparator group

Description:

Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT

Treatment:

Device: Kendall sequential compression device, model 9525