Lower-extremity Blood fl ow and Velocity in Obese vs Nonobese Pregnant Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Change in venous duplex velocity
Study Overview
Brief Summary
This is a prospective observational study comparing venous Doppler flow in the lower extremities of pregnant women. Pregnant women with a BMI >/= 30 will be compared to those with a BMI < 30.
Detailed Description
Study Outcome Measurement and Ascertainment:
Data will be collected from data in EPIC and UTMB electronic medical records. This information will include:
- Maternal demographic data, medical, family, personal, social and surgical history
- Maternal pre-pregnancy weight and height
- Maternal weight at time of delivery
- Maternal weight on post-operative day 1
- Gestational age at delivery, infant gender, birth weight, placental weight, delivery method, and complications through 6 weeks postpartum.
Venous hemodynamics will be obtained using venous duplex ultrasound. 1. Peak, mean, and minimum flow velocities and diameter will be obtained. Calculations of venous velocity amplitude, cross-sectional area, and shear stress will be made from the data collected.
Study Procedures:
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age >/= 18 years of age, planned delivery at John Sealy Hospital (JSH)
Exclusion Criteria
- •<18 years of age
- •Personal history of VTE, regardless of etiology
- •Development of VTE during this pregnancy -History of thrombophilia, bleeding disorder marked varicosities, history of recurrent stillbirth, intrauterine growth restriction
- •Any indication for emergency delivery
- •Known major fetal abnormality or genetic syndrome
Outcomes
Primary Outcomes
Change in venous duplex velocity
Time Frame: On admission for delivery of the infant and postpartum day 1 and 2
To assess if the increased risk of venous thromboembolism is observed in obese versus non-obese pregnant patients is due to compromised flow in the lower extremities.
Secondary Outcomes
No secondary outcomes reported