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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thrombophilia

Intervention / Treatment
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* Device: Kendall A-V foot impulse pump, model 6060
* Device: Kendall sequential compression device, model 9525


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Bedrest Thrombophilia Prescribed DVT prophylaxis Exclusion Criteria: Active DVT

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT | Device: Kendall A-V foot impulse pump, model 6060<br>* 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<br>|
| Active Comparator: 2<br>Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT | Device: Kendall sequential compression device, model 9525<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Level | Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort). | once during first 7 days of hospitalization | 
| Patient Compliance | Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded | for 1-7 days during hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DVT Prevention | positive DVT on ultrasound | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep vein thrombosis, thrombophilia, pregnancy, thromboprophylaxis, decreased mobility, hospitalization