Fetal Body Composition and Volumes Study

Fetal Growth Clinical Trial

Official title:

Fetal Body Composition and Volumes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692924
• Other study ID #: 999916071
• Secondary ID: 16-CH-N071
• Status: Completed
• Start date: February 25, 2016
• Est. completion date: December 15, 2021

Study information

• Verified date: November 7, 2022
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

Gravid diseases are complications in pregnancy. They include gestational diabetes and preeclampsia. These can cause problems with how a fetus grows. Being pregnant with twins can make complications more likely. Research suggests that changes in fetal soft tissue may be the earliest signs of growth problems. These tissue changes are in lean mass, fat mass, and organ size. 3D images might detect these changes earlier than 2D images. This could help manage gravid diseases. The NICHD Fetal Growth Studies - Singletons measured fetal growth for four racial groups, Caucasian, African American, Asian, and Hispanic. Fetuses of obese women and women with twins were also measured. 2D and 3D images were taken at various stages of pregnancy. Measurements were taken after birth. Researchers want to expand this study by measuring organ volumes and body composition by racial group and in twins.

Objectives:

To set standards for body composition and organ volumes by race. To understand the relationship between gravid diseases and changes in fetal body composition and organ volume over the course of pregnancy. To find out whether these are different for twins than for single pregnancies.

Eligibility:

Women who participated in the NICHD Fetal Growth Studies - Singletons and Twins.

Design:

The data will come from the NICHD Fetal Growth Studies - Singletons and Twins.

Researchers will review scans taken in the previous study. They will take measurements from the scans.

Description:

The Division of Intramural Population Health Research (DIPHR) will conduct a research study entitled: "Fetal Body Composition and Volumes Study" 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 augment the singleton Study with organ volumes by racial group and 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, thereby, complementing available data for the Cohort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2973
• Est. completion date: December 15, 2021
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

• INCLUSION CRITERIA for eligible subjects in the SINGLETON study:

• Singleton, viable pregnancy

• 8^(+0) - 13^(+6) weeks of gestation

• Maternal age 18 - 40 years

• BMI 19.0 - 29.9 kg/m(2) for low risk group; BMI 30.0 -45.0 kg/m(2) for obese group

• Firm LMP

• LMP-date and ultrasound date match within 5 days for gestation estimates between 8 weeks + 0 days and 10 weeks + 6 days, 6 days for those between 11 weeks + 0 days and 12 weeks + 6 days, and 7 days for estimates between 13 weeks + 0 days and 13 weeks + 6 days

• No confirmed or suspected fetal congenital structural or chromosomal anomalies

• Expect to deliver at one of the participating hospitals

• No previous participation in the NICHD Fetal Growth Study

EXCLUSION CRITERIA for eligible subjects in the SINGLETON study:

The following criteria apply only to non-obese women:

• Smoked cigarettes in the past six months

• Used illicit drugs in the past year

• Having at least 1 alcoholic drink per day

• Conception by ovulation stimulation drugs or assisted reproductive technology

• Chronic hypertension or renal disease under medical supervision

• Asthma requiring weekly medication

• Diabetes mellitus

• Thyroid disease under medical supervision

• Autoimmune disorder (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome, scleroderma)

• Hematologic disorders (chronic anemia, sickle cell disease, thrombocytopenia, coagulation defects, thrombophilia)

• Cancer

• HIV or AIDS

• Epilepsy or seizure on medication or occurrence within 2 years

• Psychiatric disorder (bipolar disorder, depression, anxiety disorder currently requiring medication)

• Current anorexia nervosa or bulimia

• Previous severe preeclampsia, eclampsia, HELLP syndrome

• Previous gestational diabetes

• Previous stillbirth or neonatal death

• Previous very preterm birth (<34 weeks)

• Previous low birthweight (<2,500g)

• Previous macrosomia (greater than or equal to 4,500 g)

The following criteria apply only to obese women:

• Chronic hypertension or high blood pressure requiring two or more medications

• Diabetes while not pregnant

• Chronic renal disease under medical supervision

• Autoimmune disease (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome, scleroderma)

• Psychiatric disorder (bipolar disorder, depression, anxiety disorder currently requiring medication)

• Cancer (currently receiving treatment)

• HIV or AIDS

INCLUSION CRITERIA for the TWIN study:

• Twin, viable pregnancy

• 8^(+0) -13^(+6) weeks of gestation (for larger twin)

• Maternal age 18 - 45 years

• Spontaneous pregnancy or pregnancy from ovulation induction or in vitro fertilization with known date of transfer

• Pregnancy from egg donor or embryo donor (record if anonymous or known source)

• LMP-date and crown-rump length measurement match within certain number of days according to a standard scheme (for larger twin)

• Expect to deliver at one of the participating hospitals

EXCLUSION CRITERIA for the TWIN study:

• Fetal reduction (medically induced only)

• Congenital anomalies (structural or chromosomal)

• Either twin with an increased nuchal translucency (>99th percentile for crown-rump length; i.e. 3.5 mm or more)

• Monochorionic twins

• Crown-rump length discordance >10%

Related Conditions & MeSH terms

• Fetal Growth

Locations

Country	Name	City	State
United States	National Institute of Child Health and Human Development (NICHD), 9000 Rockville	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of the catalog and 2D and 3D measurements.	Fetal body composition (subcutaneous fat, lean mass), first trimester embryo, gestational sac and placenta volumes, and organ measurements (in singletons)	Ultrasound data has already been collected