Status:
COMPLETED
Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Sigvaris Corporation
Conditions:
Venous Insufficiency
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Problem: Approximately 4 million live births occur in the United States each year. Pregnancy causes many physical changes in the mother, including venous distension, increased ability to form blood cl...
Detailed Description
Problem: There are approximately four million live births in the United States annually. Pregnancy induces multisystemic physiologic changes in the mother as her body accommodates the growing fetus. K...
Eligibility Criteria
Inclusion
- Pregnant women 18-45 years of age.
- Fetal gestation between 8-20 weeks.
- Patient is seeking care for the pregnancy at one of the study locations (Johns Hopkins East Baltimore Campus, Johns Hopkins Bayview Medical Center, and Johns Hopkins at White Marsh).
- Ability to complete informed consent and willingness to comply with protocol (return for all follow-up visits \& participate in phone interviews).
Exclusion
- Inability to wear compression stockings.
- Women who currently have been prescribed to wear compression stockings by a medical professional.
- Chronic dermatological condition (i.e. psoriasis).
- Chronic deep vein thrombus or chronic phlebitis.
- In women with varicose veins: Presence of primary outcome (superficial thrombophlebitis or DVT) on first visit ultrasound.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01793194
Start Date
February 1 2012
End Date
August 24 2014
Last Update
January 29 2018
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital
Baltimore, Maryland, United States, 21224