Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/31/2018 |
| Start Date: | February 2012 |
| End Date: | August 24, 2014 |
Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings: A Randomized Pilot Study
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.
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.
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).
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).
Inclusion Criteria:
- 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 Criteria:
- 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.
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