Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings

Completed · Not applicable

Conditions studied: Venous Insufficiency

In brief

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 be risky to both mother and fetus. The prevention or reduction of DVT in pregnant women through use of compression stockings would revolutionize their care. Further, this intervention is safe and noninvasive. The investigators propose to conduct a randomized, pilot study comparing pregnant women without and with varicose veins randomized to wear compression stockings to a similar group of participants randomized to no compression stocking use.

Key facts

Study ID

NCT01793194

Run by

Johns Hopkins University

People needed

44

Starts

2012-02-01

Expected to finish

2014-08-24

Last updated by the study team

2018-01-29

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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