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

NCT00356434 | Terminated Results

• 1 other identifier: foot pump vs SCD
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Thrombophilia

Keywords

deep vein thrombosis; thrombophilia; pregnancy; thromboprophylaxis; decreased mobility; hospitalization

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• DVT Prevention

  up to 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

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

1

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

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant
• Bedrest
• Thrombophilia
• Prescribed DVT prophylaxis

You may not qualify if:

• Active DVT

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 33779986 DERIVED

MeSH Terms

Conditions

Thrombophilia; Venous Thrombosis

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Abimbola Aina
• Organization: Johns Hopkins Univ

aaina1@jhmi.edu

410-955-8496

Study Officials

• Abimbola Aina, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 26, 2006
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 18, 2017
• Results First Posted: August 18, 2017

Record last verified: 2017-07

Locations

US (2)