Clinical Trials Logo

Clinical Trial Summary

Normal fetal growth is a critical component for a healthy pregnancy and for ensuring the health and well-being of infants throughout childhood and adolescence. One promising area of research suggests that changes in fetal soft tissue may be the earliest changes that occur in pathologic growth. Three-dimensional volume assessments may be used to detect changes in fetal lean mass, fat mass, and organ size that result from pathologic growth earlier than conventional 2D measures. This knowledge may lead to interventions that could minimize or prevent pregnancy and newborn health problems in the future.


Clinical Trial Description

The NICHD Fetal Growth Study was a multi-site, prospective cohort study designed to establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population. For the singleton study, 2,334 low-risk, non-obese gravidas were recruited from each of 4 self-identified race/ethnicity backgrounds. An additional 468 obese women and 171 dichorionic twin gestations were recruited. After an initial sonogram in the first trimester, women were randomized to serial ultrasonology schedules. Each schedule comprised five additional sonograms for fetal biometry (six in twins) plus additional image and 3D volume acquisition for later analysis. Ultrasound measurements at each follow-up visit included standard fetal biometrics ((BPD, HC, AC, FL) and the following volumes in the singleton study if they were able to be obtained: 1st trimester: fetus and gestational sac; 2nd and 3rd trimesters: head, cerebellum, face, chest, heart, abdomen, pelvis, arm and thigh. In twins, the volumes collected were 1st trimester: fetus and gestational sac and in the 2nd and 3rd trimesters the thigh. In addition to ultrasound, this study recorded maternal anthropometrics and a brief interview to capture changes in health status, stress and depression, and physical activity at each follow-up visit. Blood draws at baseline and at targeted gestational ages were obtained for the eventual identification of biomarkers indicative of fetal growth were collected. After delivery, neonatal anthropometric measures were assessed, placental biospecimens were collected, and select information about the obstetrical course and newborn status were abstracted from medical charts. The Fetal 3D Study is being conducted to catalog and perform 2 Dimensional (2D) and 3 Dimensional (3D) measurement of the obstetrical ultrasound images in the existing bank of singleton and twin gestations collected from the NICHD Fetal Growth Studies. The research study aims to understand the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat, lean mass) and organ measurements (in singletons) over the course of pregnancy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03266198
Study type Observational
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact
Status Completed
Phase
Start date April 27, 2016
Completion date September 15, 2019

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Recruiting NCT05601375 - Speckle Tracking Echocardiography in Infants, Prenatally and Postnatally
Recruiting NCT03662178 - Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
Completed NCT05059093 - Developing and Testing AI Models for Fetal Biometry and Amniotic Volume Assessment in Fetal Ultrasound Scans.
Completed NCT03067298 - Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Recruiting NCT01981824 - Prediction of Growth Restricted Fetuses Using Femur Length to Mid-thigh Circumference Ratio: A Case-control Study N/A
Recruiting NCT04215107 - Fetal Distribution of Feto-placental Blood Flow Related to Placental Nutrient Transport and Maternal Food Intake N/A
Completed NCT02189148 - First-trimester Prediction of Preeclampsia
Terminated NCT04084990 - Sleep Apnea and Fetal Growth Restriction Phase 3
Recruiting NCT04051567 - Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies Phase 4
Recruiting NCT04394611 - Metals and in Fetal Growth Restriction
Completed NCT01369940 - The NICHD Fetal Growth Study: Twin Gestations N/A
Not yet recruiting NCT03121196 - Social Deprivation and Pregnancy N/A
Recruiting NCT03177824 - Sildenafil Citrate for Treatment of Growth-restricted Fetuses Phase 3
Completed NCT02379832 - Pre-Eclampsia And Growth Restriction: a Longitudinal Study
Completed NCT02379494 - First Trimester Prediction of Preeclampsia and Fetal Growth Restriction N/A
Completed NCT03046355 - Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women N/A
Not yet recruiting NCT05848869 - Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction N/A
Recruiting NCT04438668 - Evaluation of the Safety and Performance of Centaflow N/A
Recruiting NCT05423665 - Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies