An interventional study of Kendall A-V foot impulse pump, model 6060 and Kendall sequential compression device, model 9525 in Thrombophilia, sponsored by Johns Hopkins University. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
75 studies on the registry are indexed under Thrombophilia; 16 are open to participants now.
This study's enrollment of 11 is below the median of 86 across 23 interventional studies indexed under Thrombophilia.
Browse Thrombophilia studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
Patient Compliance
Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded
Time frame: for 1-7 days during hospitalization
DVT Prevention
positive DVT on ultrasound
Time frame: up to 3 months
| Milestone | Foot Pump | Sequential Compression Device |
|---|---|---|
| Started | 4 | 7 |
| Completed | 4 | 7 |
| Not completed | 0 | 0 |
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).
| units on a scale | Foot Pump | Sequential Compression Device |
|---|---|---|
| Comfort Level | 7 (5 to 8) | 8 (6 to 10) |
Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded
No measurements were reported for this outcome.
positive DVT on ultrasound
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Foot Pump | — | 0/4 (0%) | 0/4 (0%) |
| Sequential Compression Device | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Foot Pump | Sequential Compression Device | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 7 | 11 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Foot Pump | Sequential Compression Device | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Foot Pump | Sequential Compression Device | Total |
|---|---|---|---|
| United States | 4 | 7 | 11 |
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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