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Validation of Ultrasound in Predicting a Low Lying Placenta Throughout Pregnancy

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ClinicalTrials.gov Identifier: NCT02689739
Recruitment Status : Withdrawn
First Posted : February 24, 2016
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment
Pregnancy Obese Procedure: venous duplex ultrasound

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Lower-extremity Blood fl ow and Velocity in Obese vs Nonobese Pregnant Women
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Group/Cohort Intervention/treatment
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
Venous duplex ultrasound

Non-obese Pregnant cohort
This will be the control group of non-obese women (BMI <30).
Procedure: venous duplex ultrasound
Venous duplex ultrasound




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689739


Locations
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United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Study Director: Gayle Olson, MD UTMB
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02689739    
Other Study ID Numbers: 15-0143
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share data.