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PI assigned to a different hospital;difficulty recruiting patients
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT |
|
| 2 | Active Comparator | Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kendall A-V foot impulse pump, model 6060 | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | once during first 7 days of hospitalization |
| Patient Compliance | Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded | for 1-7 days during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| DVT Prevention | positive DVT on ultrasound | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abimbola Aina, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States | ||
| Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33779986 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Foot Pump | Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT) 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 |
| FG001 | Sequential Compression Device | Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Foot Pump | Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Full Range | units on a scale | once during first 7 days of hospitalization |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foot Pump | Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abimbola Aina | Johns Hopkins Univ | 410-955-8496 | aaina1@jhmi.edu |
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| ID | Term |
|---|---|
| D019851 | Thrombophilia |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
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| Kendall sequential compression device, model 9525 | Device | 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 |
|
| Baltimore |
| Maryland |
| 21287 |
| United States |
| BG001 |
| Sequential Compression Device |
Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Patient Compliance | Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded | Data was not collected for this outcome measure, as the study was terminated prematurely. | Posted | for 1-7 days during hospitalization |
|
|
| Secondary | DVT Prevention | positive DVT on ultrasound | Data was not collected for this outcome measure, as the study was terminated prematurely. | Posted | up to 3 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Sequential Compression Device | Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT 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 | 0 | 7 | 0 | 7 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |