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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00356434
Other study ID # foot pump vs SCD
Secondary ID
Status Terminated
Phase N/A
First received July 24, 2006
Last updated July 22, 2016
Start date November 2008
Est. completion date December 2009

Study information

Verified date July 2016
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

We 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. We 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Pregnant

- Bedrest

- Thrombophilia

- Prescribed DVT prophylaxis

Exclusion Criteria:

- Active DVT

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary comfort level once during first 7 days of hospitalization No
Primary patient compliance for 1-7 days during hospitalization Yes
Secondary DVT prevention during entire hospitalization/immobility period Yes
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