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Completed

NCT Number: NCT03266198

Fetal 3D Study (Fetal Body Composition and Volumes Study)

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.

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Key information

Conditions

Fetal Growth Restriction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Abnormality Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Baylor College of Medicine

Houston, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with ultrasound data collected from the NICHD Fetal Growth Studies-Singletons and Twin Gestations

Exclusion criteria

  • None

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Standards for fetal body composition and organ volumes by maternal race/ethnicity

    Time frame: 3 years

    Growth trajectories in singletons and dichorionic twin pregnancies will be created using two- and selected three-dimensional ultrasound measures. Measures in singletons include fetal body composition from 2D abdominal circumference, arm and thigh volumes; cerebellum; adrenal glands; kidneys; liver; pancreas; lungs; first trimester gestational sac, embryo and placenta, using standardized protocols. Measures in twins include 2D abdominal circumference and thigh volumes, and first trimester gestational sac, embryo and placenta.

    Measurements will be performed using stored ultrasound images and 3D volumes that were collected in the NICHD Fetal Growth Studies - Singleton and Twins ClinicalTrials.gov Identifier: NCT00912132 and NCT01369940, respectively. Women were recruited during the first trimester and followed until delivery. Each woman had scheduled ultrasound examinations, one at enrollment and five during follow-up visits (six for twins).

  2. Comparison of fetal 2D and 3D in pregnancies with complications with fetuses in the singleton standard

    Time frame: 3 years

    The study will assess the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat and lean body mass) and organ volumes, and compare to those fetuses growing under optimal circumstances (i.e., singleton gestations included in the development of the fetal growth standard.

  3. Investigation of organ volumes (and ratios to fetal weight) and mass (fat) size in association with gravid or neonatal complications, such as kidney to fetal weight in fetal growth restriction, and liver to fetal weight in diabetes, by race/ethnicity

    Time frame: 3 years

  4. Exploration of factors that influence these associations

    Time frame: 3 years

    The study will determine whether potentially modifiable factors including maternal BMI, weight gain, longitudinal changes in maternal body composition, and nutrition and lifestyle factors modifies the relationship between longitudinal changes in fetal body composition (subcutaneous fat and lean body mass) and organ volumes and gravid diseases, and whether they vary by plurality (singleton or twin).

  5. Biomarkers in relation to fetal body composition and 3D volumes

    Time frame: 3 years

    Longitudinal data will compare singleton and twin gestations with respect to maternal biomarkers of fetal growth, well-being and maternal nutritional status using banked biospecimens to determine if the biomarkers ranges established for singletons are applicable to twin gestations.

Sponsors and collaborators

Lead sponsor

Katherine Grantz

Nih

Collaborators

  • Baylor College of Medicine

Registry information

Official study title

Fetal Body Composition and Volumes Study

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2017
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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