Fetal Growth Evaluation by Three-Dimensional Ultrasound

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340171
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an important cause for increased perinatal mortality in the United States. Toward this end, accurate fetal weight determinations are very important for guiding prenatal care. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to arbitrarily scan through a digital ultrasound volume dataset, visualize organs from different perspectives, and render anatomical features through computer processing. It also allows the retrospective measurement of distances and volumes even in the physical absence of the patient.

A maximum of 400 pregnancies will be serially studied by three-dimensional ultrasound to characterize the growth of volume parameters such as the fetal thigh. This information will be applied to the Rossavik model of individualized growth assessment. The technique allows growth evaluation by comparing various ultrasound measurements or birth characteristics to the individual growth standards specified by the prediction model. Newborn infant body composition will also be studied within 48 hours of delivery.

A separate cross-sectional study of up to 2,577 fetuses will allow development of birth weight prediction models based upon fetal volume measurements and further analysis of fetal growth abnormalities. Individual growth curve standards utilizing these volume parameters should allow one to evaluate deviations from expected growth or birth weight by using each fetus as its own control.


Condition
Fetal Growth Abnormalities

Study Type: Observational
Official Title: Fetal Growth Evaluation by Three-Dimensional Ultrasound

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 4518
Study Start Date: November 1997
Detailed Description:

Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an important cause for increased perinatal mortality in the United States. Toward this end, accurate fetal weight determinations are very important for guiding prenatal care. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to arbitrarily scan through a digital ultrasound volume dataset, visualize organs from different perspectives, and render anatomical features through computer processing. It also allows the retrospective measurement of distances and volumes even in the physical absence of the patient.

This protocol consists of two study arms and emphasizes the ability of 3D ultrasound to reliably measure fetal soft tissue as an index of generalized nutritional status. The longitudinal arm will enroll 400 pregnancies to allow the use of 2D and 3D ultrasonography for characterizing serial growth patterns of sonographic parameters throughout pregnancy. This approach compares ultrasound measurements or birth characteristics to individual growth standards specified by Rossavik prediction models. After delivery, a maximum of 329 newborn infants, resulting from the same pregnancies, will have correlative photographs and measurements of their head, abdomen, thigh, skin folds, weight, and crown-heel length taken to classify growth outcome. Noninvasive air displacement plethymography will be used to measure neonatal percent body fat and lean body mass after delivery. Infant body composition data will allow the precise classification of neonatal growth outcome for subsequent correlation to prenatal sonographic studies. The cross-sectional arm of this protocol will allow sonographic studies of 2,577 fetuses with similar correlative neonatal evaluation of 1,212 infants for a total of 3,789 subjects. The results will be used to develop a new fetal weight estimation models that combine 2D and 3D sonographic parameters to improve accuracy and precision of these predictions. A maximum of 50 newborns from this cross-sectional arm will also be re-evaluated for infant body composition at 1 and 2 weeks following delivery to document changes in percent body fat and fat-free mass. Therefore, the subject recruitment ceiling would be (2,577 mothers + 1,212 infants) + (400 mothers + 329 infants) or 4,518 total subjects for this Protocol.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

ALL SUBJECTS:

Pregnant women between the ages of 18 and 40 years at Hutzel and William Beaumont Hospital sites.

LOGITUDINAL ARM:

Single gestation.

No pregnancy complications.

Accurate dating criteria (sure LMP or first trimester scan).

CROSS-SECTIONAL ARM OF PROTOCOL:

Singe Gestation.

No pregnancy complications.

Accurate data criteria (sure LMP or 1st trimester scan).

Delivery anticipated within 4 days of scan.

INFANT BODY COMPOSITION STUDY

Birthweight above 1,000 grams

EXCLUSION CRITERIA:

LONGITUDINAL ARM OF PROTOCOL:

Poor visualization of the fetus due to technical factors (e.g. obesity).

Risk factors that increase risk for not keeping serial ultrasound appointments.

CROSS-SECTIONAL ARM OF PROTOCOL:

Poor visualization of the fetus due to technical factors (e.g. obesity).

Hemodynamically unstable patients.

INFANT BODY COMPOSITION STUDY

Infants requiring mechanical ventilation, heart monitors, or intravenous fluid.

Hemodynamically unstable infant

Infants with thermoregulation problems

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340171

Contacts
Contact: Roberto Romero, M.D. (313) 993-2700 romeror@mail.nih.gov

Locations
United States, Michigan
Hutzel Women's Hospital Recruiting
Detroit, Michigan, United States, 48201
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00340171     History of Changes
Other Study ID Numbers: 999997068, OH97-CH-N068
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Intrauterine Growth Retardation
Macrosomia
Fetal Volume
Fetal Anatomy
Prediction of Birthweight
3D Ultrasonography
Fetus
Prenatal Diagnosis

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014