search
Back to results

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

Primary Purpose

Venous Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression Stockings
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Insufficiency focused on measuring venous insufficiency, varicose veins, pregnancy, DVT, superficial thrombophlebitis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Stocking Use

Compression Stocking Use

Arm Description

For pregnant women randomized to the no stocking use group, no compression stockings will be worn.

Patients who are randomized to the stocking use group (Treatment Subgroup A) will be formally measured for their stockings by a certified stocking fitter, given (at no charge) two pair of 20-30mmg Hg maternity pantyhose compression stockings, and will undergo a brief tutorial regarding how to put the stockings on. Each patient will be instructed to wear the stockings on a daily basis, during the day.

Outcomes

Primary Outcome Measures

Incidence of varicose veins
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).
Incidence of superficial thrombophlebitis and DVT
In pregnant women who already have varicose veins (Group 2): To quantify and compare the incidence of superficial thrombophlebitis and DVT between those randomized to the compression stocking use group (Group 2A) and those randomized to the no compression stocking use group (Group 2B).

Secondary Outcome Measures

Incidence of symptoms of venous insufficiency
For All Groups: To quantify and compare the incidence of symptoms of venous insufficiency in pregnant women between the treatment and control groups.

Full Information

First Posted
February 14, 2013
Last Updated
January 25, 2018
Sponsor
Johns Hopkins University
Collaborators
Sigvaris Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01793194
Brief Title
Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings
Official Title
Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings: A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
August 24, 2014 (Actual)
Study Completion Date
August 24, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Sigvaris Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
venous insufficiency, varicose veins, pregnancy, DVT, superficial thrombophlebitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Stocking Use
Arm Type
No Intervention
Arm Description
For pregnant women randomized to the no stocking use group, no compression stockings will be worn.
Arm Title
Compression Stocking Use
Arm Type
Experimental
Arm Description
Patients who are randomized to the stocking use group (Treatment Subgroup A) will be formally measured for their stockings by a certified stocking fitter, given (at no charge) two pair of 20-30mmg Hg maternity pantyhose compression stockings, and will undergo a brief tutorial regarding how to put the stockings on. Each patient will be instructed to wear the stockings on a daily basis, during the day.
Intervention Type
Other
Intervention Name(s)
Compression Stockings
Intervention Description
20-30mmg Hg maternity pantyhose compression stockings
Primary Outcome Measure Information:
Title
Incidence of varicose veins
Description
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).
Time Frame
8 weeks post-partum
Title
Incidence of superficial thrombophlebitis and DVT
Description
In pregnant women who already have varicose veins (Group 2): To quantify and compare the incidence of superficial thrombophlebitis and DVT between those randomized to the compression stocking use group (Group 2A) and those randomized to the no compression stocking use group (Group 2B).
Time Frame
8 weeks post-partum
Secondary Outcome Measure Information:
Title
Incidence of symptoms of venous insufficiency
Description
For All Groups: To quantify and compare the incidence of symptoms of venous insufficiency in pregnant women between the treatment and control groups.
Time Frame
8 weeks post-partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Heller, MD
Organizational Affiliation
Div. of Vascular Surgery, Johns Hopkins University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs