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

Thrombophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00356434
• Other study ID #: foot pump vs SCD
• 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

• Thrombophilia

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