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NCT01793194 · ClinicalTrials.gov registry record · NA
Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings
A NA study of Venous Insufficiency, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT01793194 is a NA study of Venous Insufficiency that has completed, run by Johns Hopkins University. The registered enrollment target is 44 participants, below the 147-participant average among 9 other Venous Insufficiency trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01793194, a NA study of Venous Insufficiency, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study 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 clots, and hormonal changes. Data suggest that these factors help cause venous insufficiency (when the veins do not adequately return blood from the extremities to the torso). As venous insufficiency progresses, complications follow, the most severe of which include superficial thrombophlebitis and deep venous thrombosis (DVT, or blood clots). Although the fear of DVT has been well publicized, its prevention and prevalence in pregnant women has not been well-studied. The exact cause of venous insufficiency is not known. However, known risk factors include being female and hormonal changes associated with oral contraceptive use, certain hormone replacement medications, and pregnancy. Being pregnant places the mother at additional risk for developing venous insufficiency. Compression stockings are used to manage the condition, but this is by no means standard of care despite their easy use and safety. The medical community's understanding of how compression stockings work is largely theoretical; however, it is believed that the compression works by preventing venous hypertension in the lower legs, thereby preventing venous insufficiency and its associated complications. Research hypothesis: The investigators hypothesize that compression stocking use will be associated with lower incidence of varicose veins and, in those patients who already have varicose veins, lower incidence of complications associated with venous insufficiency. Further, the investigators believe that compression stocking use will be associated with a lower incidence or lessening of symptoms associated with venous insufficiency. Importance: An undetected DVT can be fatal. Even if detected promptly, DVT is associated with long term health problems. Treatment of a DVT requires anticoagulation which can
Conditions Studied
Interventions
- OTHER Compression Stockings
Study Locations (1)
Maryland
- Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-08-24 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01793194
The ClinicalTrials.gov registry entry for NCT01793194 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 147-participant average among 9 other Venous Insufficiency trials with a reported enrollment target (70% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Venous Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Compression Stockings is the first listed.
NCT01793194 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01793194 about?
NCT01793194 is a clinical study titled "Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings". 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 clots, and hormonal changes. Data suggest that these factors help cause venous insufficiency (when the...
What is the current status of trial NCT01793194?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2012-02. Estimated completion is 2014-08-24.
What conditions does trial NCT01793194 study?
This clinical trial studies the following conditions: Venous Insufficiency.
What interventions are being tested in trial NCT01793194?
The interventions under investigation include: Compression Stockings (OTHER).
Who is sponsoring clinical trial NCT01793194?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01793194 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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