Thrombophilia
Conditions
Keywords
deep vein thrombosis, thrombophilia, pregnancy, thromboprophylaxis, decreased mobility, hospitalization
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.
Interventions
DEVICEKendall 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
DEVICEKendall 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
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant * Bedrest * Thrombophilia * Prescribed DVT prophylaxis
Exclusion criteria
* Active DVT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Level | 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). |
| Patient Compliance | for 1-7 days during hospitalization | Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DVT Prevention | up to 3 months | positive DVT on ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 7 |
| Total | 11 |
Baseline characteristics
| Characteristic | Foot Pump | Sequential Compression Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 |
Outcome results
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).
Time frame: once during first 7 days of hospitalization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Foot Pump | Comfort Level | 7 units on a scale |
| Sequential Compression Device | Comfort Level | 8 units on a scale |
Primary
Patient Compliance
Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded
Time frame: for 1-7 days during hospitalization
Population: Data was not collected for this outcome measure, as the study was terminated prematurely.
Secondary
DVT Prevention
positive DVT on ultrasound
Time frame: up to 3 months
Population: Data was not collected for this outcome measure, as the study was terminated prematurely.