- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793194
Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center and Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No Stocking Use
For pregnant women randomized to the no stocking use group, no compression stockings will be worn.
|
|
EXPERIMENTAL: Compression Stocking Use
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.
|
20-30mmg Hg maternity pantyhose compression stockings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of varicose veins
Time Frame: 8 weeks post-partum
|
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
Time Frame: 8 weeks post-partum
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of symptoms of venous insufficiency
Time Frame: 8 weeks post-partum
|
For All Groups: To quantify and compare the incidence of symptoms of venous insufficiency in pregnant women between the treatment and control groups.
|
8 weeks post-partum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Heller, MD, Div. of Vascular Surgery, Johns Hopkins University School of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00047720
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Venous Insufficiency
-
Value Outcomes Ltd.Alfasigma S.p.A.RecruitingChronic Venous Disease | Chronic Insufficiency VenousCzechia
-
State Budgetary Healthcare Institution, National...CompletedEndothelial Dysfunction | Venous Insufficiency of Leg | Venous Insufficiency (Chronic)(Peripheral)Russian Federation
-
GCS Ramsay Santé pour l'Enseignement et la RechercheVivactis M2ResearchRecruitingSuperficial Venous InsufficiencyFrance
-
C. R. BardEnrolling by invitation
-
Medtronic EndovascularCompletedVenous Insufficiency of LegUnited Kingdom, Denmark, Germany, Netherlands
-
Hancock Jaffe Laboratiores, IncSyntactx; AXIOM Real Time MetricsRecruitingDeep Venous Insufficiency (Diagnosis)United States
-
Medtronic EndovascularCompleted
-
Angiodynamics, Inc.Completed
-
Shannon HernonGalway ClinicUnknownChronic Venous InsufficiencyIreland
-
Virginia Commonwealth UniversityCompletedChronic Venous InsufficiencyUnited States
Clinical Trials on Compression Stockings
-
University of WashingtonLake Washington Vascular; Sigvaris, IncUnknownVaricose VeinsUnited States
-
Imperial College LondonNational Institute for Health Research, United KingdomNot yet recruitingSurgery | Venous Thromboembolism
-
University Hospital ErlangenCompletedVascular Diseases | Vascular Malformations | Venous Malformation | Vascular Malformation PeripheralGermany
-
Federal University of São PauloUnknownQuality of Life | Cellulitis
-
NYU Langone HealthNot yet recruiting
-
Belarusian State Medical UniversityCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedObstructive Sleep Apnea | Renal Failure Chronic Requiring DialysisBrazil
-
Assistance Publique - Hôpitaux de ParisPoitiers University Hospital; Pierre and Marie Curie UniversityCompleted
-
Singapore General HospitalNational University of Ireland, Galway, IrelandUnknownVaricose Veins | Chronic Venous InsufficiencySingapore, Ireland
-
Imperial College LondonUniversity of Edinburgh; Universidad de GranadaRecruitingVenous ThromboembolismUnited Kingdom