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

This study has been terminated.
(PI assigned to a different hospital;difficulty recruiting patients)
Sponsor:
Information provided by (Responsible Party):
Abimbola Aina, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00356434
First received: July 24, 2006
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Thrombophilia
 Device: Kendall A-V foot impulse pump, model 6060
Device: Kendall sequential compression device, model 9525

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • comfort level [ Time Frame: once during first 7 days of hospitalization ] [ Designated as safety issue: No ]
  • patient compliance [ Time Frame: for 1-7 days during hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • DVT prevention [ Time Frame: during entire hospitalization/immobility period ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
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
Active Comparator: 2
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
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Bedrest
  • Thrombophilia
  • Prescribed DVT prophylaxis

Exclusion Criteria:

  • Active DVT
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356434

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Abimbola Aina, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Abimbola Aina, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00356434     History of Changes
Other Study ID Numbers: foot pump vs SCD
Study First Received: July 24, 2006
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
deep vein thrombosis
thrombophilia
pregnancy
 thromboprophylaxis
decreased mobility
hospitalization

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013