Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT00356434
Status:
TERMINATED
Last Update Posted:
2017-08-18
First Post:
2006-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI assigned to a different hospital;difficulty recruiting patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: