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

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ClinicalTrials.gov Identifier: NCT00356434
Recruitment Status : Terminated (PI assigned to a different hospital;difficulty recruiting patients)
First Posted : July 26, 2006
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Thrombophilia Device: Kendall A-V foot impulse pump, model 6060 Device: Kendall sequential compression device, model 9525 Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Comfort Level [ Time Frame: once during first 7 days of hospitalization ]
    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).

  2. Patient Compliance [ Time Frame: for 1-7 days during hospitalization ]
    Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded


Secondary Outcome Measures :
  1. DVT Prevention [ Time Frame: up to 3 months ]
    positive DVT on ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Bedrest
  • Thrombophilia
  • Prescribed DVT prophylaxis

Exclusion Criteria:

  • Active DVT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356434


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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00356434     History of Changes
Other Study ID Numbers: foot pump vs SCD
First Posted: July 26, 2006    Key Record Dates
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases