Validation of Ultrasound in Predicting a Low Lying Placenta Throughout Pregnancy

NCT02689739 | Withdrawn

• 1 other identifier: 15-0143
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Obese

Outcome Measures

Primary Outcomes (1)

• Change in venous duplex velocity

  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.

  On admission for delivery of the infant and postpartum day 1 and 2

Study Arms (2)

Obese Pregnant cohort

Women will be consented to participate and then separated into a study group of obese women (BMI \>/= 30).

Procedure: venous duplex ultrasound

Non-obese Pregnant cohort

This will be the control group of non-obese women (BMI \<30).

Procedure: venous duplex ultrasound

Interventions

venous duplex ultrasound PROCEDURE

Venous duplex ultrasound

Non-obese Pregnant cohort; Obese Pregnant cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective 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 who deliver at UTMB.

You may qualify if:

• Age \>/= 18 years of age, planned delivery at John Sealy Hospital (JSH)

You may not qualify if:

• \<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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gayle Olson, MD

  UTMB

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: February 24, 2016
• Study Start: July 1, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: October 26, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)