Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

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 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.
    

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. Known physiologic alterations include venous distension,
      hypercoagulability, and hormonal changes. Anecdotal data suggests that these particular
      factors precipitate the development of venous insufficiency. As venous insufficiency
      progresses, complications ensue, the most severe of which include superficial
      thrombophlebitis and deep venous thrombosis. Although the fear of deep venous thrombus (DVT)
      has been well publicized, its prevention and actual prevalence in the pregnant population has
      not been adequately studied.

      The precise mechanism of venous insufficiency has yet to be elucidated. However, several
      known risk factors exist. They include female gender and hormonal changes associated with
      elevated progesterone levels such as oral contraceptive use, certain exogenous hormonal
      replacement medications, and pregnancy. Clearly, the pregnant state places the mother at
      additive risk for subsequent development of venous insufficiency.

      Medical management of venous insufficiency consists of compression stocking use, and some
      physicians do recommend their use to pregnant patients. However, this practice is by no means
      standard of care, despite its noninvasive application and safety. The precise mechanism
      through which compression stockings work is largely theoretical; however, it is believed that
      the extrinsic graduated compression works by preventing venous hypertension in the distal
      lower extremity, 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,
      particularly superficial thrombophlebitis and deep venous thrombosis (DVT). Further, the
      investigators believe that compression stocking use will be associated with a lower incidence
      or lessening of symptoms associated with venous insufficiency, such as edema, fatigue, venous
      stasis dermatitis, and venous neuropathy (burning).

      Importance: While some may feel that varicose veins, edema, fatigue, and other outcomes are
      unimportant, an undetected DVT is commonly a fatal event. Even if detected promptly, DVT is
      associated with long term morbidity, such as post thrombotic syndrome which can occur in up
      to 30% of those patients diagnosed with a DVT. Treatment of a DVT requires anticoagulation
      which, although essential, carries significant risk to both mother and fetus. The prevention
      or reduction in incidence of DVT in this population merely with compression stocking use
      would revolutionize care in the pregnant population. Further, this intervention is safe and
      noninvasive.

      The investigators propose to conduct a randomized, pilot study comparing pregnant women
      without (Group 1) and with (Group 2) varicose veins randomized to wear compression stockings
      (Treatment Subgroup A) to a similar group of participants randomized to no compression
      stocking use (Control Subgroup B).
    

Intervention name(s): Compression Stockings
Intervention type(s): Other
Intervention description(s): 20-30mmg Hg maternity pantyhose compression stockings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: venous insufficiency; varicose veins; pregnancy; DVT; superficial thrombophlebitis