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| Sponsored by: |
Johns Hopkins University |
|---|---|
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00356434 |
Purpose
We, 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: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention |
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
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
|
|
2: Active Comparator
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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Abimbola Aina-Mumuney, MD | 410-502-2345 | aaina1@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| Johns Hopkins Bayview Medical Center | |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: | Abimbola Aina, MD | Johns Hopkins University |
More Information
| Responsible Party: | Johns Hopkins University Dept GYN/OB ( Abimbola Aina-Mumuney MD ) |
| Study ID Numbers: | foot pump vs SCD |
| Study First Received: | July 24, 2006 |
| Last Updated: | June 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00356434 |
| Health Authority: | United States: Institutional Review Board |
|
deep vein thrombosis thrombophilia pregnancy |
thromboprophylaxis decreased mobility hospitalization |
|
Hematologic Diseases Thrombophilia Venous Thrombosis Thrombosis |
