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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: Completed NA study of Venous Insufficiency, sponsored by Johns Hopkins University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

In pregnant women who do not have varicose veins (Group 1): To quantify and compare the incidence of varicose veins between participants randomized to the compression stocking use group (Group 1A) and those randomized to the no compression stocking use group (Group 1B).

Conditions Studied

Interventions

  • OTHER Compression Stockings

Study Locations (1)

Maryland

  • Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital - Baltimore

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2012-02
Est. Completion 2014-08-24
Phase NA
Johns Hopkins University

1,448 total trials

What the finished NCT01793194 record still lists

NCT01793194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 147-participant average among 9 other Venous Insufficiency trials with a reported enrollment target (70% lower).

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 a single indexed study location in 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.

Similar trials for Venous Insufficiency

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01793194's enrollment target sits among peer trials

44 8th of 9 higher than 2 of 9 other Venous Insufficiency trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Venous Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01793194, the US trial registry maintained by the National Library of Medicine. NCT01793194 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.