A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population
Primary Purpose
Thrombophilia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kendall A-V foot impulse pump, model 6060
Kendall sequential compression device, model 9525
Sponsored by
About this trial
This is an interventional prevention trial for Thrombophilia focused on measuring deep vein thrombosis, thrombophilia, pregnancy, thromboprophylaxis, decreased mobility, hospitalization
Eligibility Criteria
Inclusion Criteria: Pregnant Bedrest Thrombophilia Prescribed DVT prophylaxis Exclusion Criteria: Active DVT
Sites / Locations
- Johns Hopkins Bayview Medical Center
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT
Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Outcomes
Primary Outcome Measures
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).
Patient Compliance
Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded
Secondary Outcome Measures
DVT Prevention
positive DVT on ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00356434
Brief Title
A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population
Official Title
Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
PI assigned to a different hospital;difficulty recruiting patients
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombophilia
Keywords
deep vein thrombosis, thrombophilia, pregnancy, thromboprophylaxis, decreased mobility, hospitalization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
Intervention Type
Device
Intervention Name(s)
Kendall A-V foot impulse pump, model 6060
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Kendall sequential compression device, model 9525
Intervention Description
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 Measure Information:
Title
Comfort Level
Description
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).
Time Frame
once during first 7 days of hospitalization
Title
Patient Compliance
Description
Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded
Time Frame
for 1-7 days during hospitalization
Secondary Outcome Measure Information:
Title
DVT Prevention
Description
positive DVT on ultrasound
Time Frame
up to 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant
Bedrest
Thrombophilia
Prescribed DVT prophylaxis
Exclusion Criteria:
Active DVT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abimbola Aina, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33779986
Citation
Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
Results Reference
derived
Learn more about this trial
A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population
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