A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population

Not Applicable

Terminated

• Conditions: Thrombophilia
• Interventions: Device: Kendall sequential compression device, model 9525; Device: Kendall A-V foot impulse pump, model 6060

• Registration Number: NCT00356434
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-26
• Study Start: 2008-11
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Results First Submitted: 2017-04-18
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-20
• Last Update Submitted: 2017-07-20
• Results First Posted: 2017-08-18
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

• Pregnant
• Bedrest
• Thrombophilia
• Prescribed DVT prophylaxis

Exclusion Criteria

• Active DVT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Kendall sequential compression device, model 9525	Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
1	Kendall A-V foot impulse pump, model 6060	Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT

Primary Outcome Measures

Name	Time	Method
Patient Compliance	for 1-7 days during hospitalization	Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded
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).

Secondary Outcome Measures

Name	Time	Method
DVT Prevention	up to 3 months	positive DVT on ultrasound

Trial Locations

Locations (2)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States