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

NCT01793194 | Completed

• 1 other identifier: NA_00047720
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency

Keywords

venous insufficiency; varicose veins; pregnancy; DVT; superficial thrombophlebitis

Outcome Measures

Primary Outcomes (2)

• 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).

  8 weeks post-partum

• 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).

  8 weeks post-partum

Secondary Outcomes (1)

• Incidence of symptoms of venous insufficiency

  8 weeks post-partum

Study Arms (2)

No Stocking Use

NO INTERVENTION

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

Compression Stocking Use

EXPERIMENTAL

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.

Other: Compression Stockings

Interventions

Compression Stockings OTHER

20-30mmg Hg maternity pantyhose compression stockings

Compression Stocking Use

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Sigvaris Corporation: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Venous Insufficiency; Varicose Veins

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• Jennifer Heller, MD

  Div. of Vascular Surgery, Johns Hopkins University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2012
• Primary Completion: August 24, 2014
• Study Completion: August 24, 2014
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

US (1)