Baylor College of Medicine

3D Umbilical Venous Flow - A New Paradigm for Improving the Assessment of Fetal Growth Restriction (GRACE Study) (H-45622)

Description

Content

The GRACE study is a multicenter study, funded by the National Institute of Child Health and Human Development, that will enroll about 1,600 pregnant women at three different study sites across the country. 

The delivery of a small baby impacts families and health care systems alike. An important challenge for healthcare providers is distinguishing between babies that are born small from those who do not grow well during pregnancy.

A new ultrasound method has been developed that measures the blood flow in the umbilical cord using 3D ultrasound. This non-invasive ultrasound technique may improve the ability to monitor small babies and their risk for poor health outcomes. Participation involves having serial ultrasound scans throughout your pregnancy to estimate the baby's weight and obtain measurements of the blood flow in the umbilical cord. This new approach is easy to use and safe throughout all trimesters of pregnancy.

Participants will be compensated for their time and be given 3D ultrasound images of their baby periodically throughout the study. 

Inclusion Criteria

Validation Group

  • No major medical or obstetrical complications
  • One half of the volunteers with BMI between 30-40kg/m2 at first prenatal visit
  • Maternal age at least 18 years
     

Uncomplicated Pregnancy Group

  • No major medical illnesses, genetic abnormalities, or obstetrical complications
  • BMI< 40 kg/m2 at first prenatal visit
  • Maternal age at least 18 years
  • Willingness to participate in serial ultrasound scans
  • Delivery at TCH Pavilion for Women
     

Small Fetus Group

  • EFW < 10th percentile for menstrual age
  • First TM dating scan or second TM biometry [BPD, HC, AC, FDL]< 16 weeks, MA
  • Maternal age at least 18 years
  • Willingness to participate in serial ultrasound scans
  • Delivery at TCH Pavilion for Women
     

Exclusion Criteria

Validation Group

  • Presence of genetic or major structural anomalies

     

Uncomplicated Pregnancy Group & Small Fetus Group

  • Presence of genetic or major structural anomalies at time of enrollment
     

IRB: H-45622

Status:

Active

Created:

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