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COMPLETED

Fetal Growth Evaluation by Three-Dimensional Ultrasound

NCT00340171 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Study Locations (2)

Michigan

  • Hutzel Women's Hospital — Detroit
  • William Beaumont Hospital — Royal Oak

Trial Details

FieldValue
Enrollment Target 1,919 participants
Start Date 1997-12-04
Est. Completion 2012-11-05

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00340171

The ClinicalTrials.gov registry entry for NCT00340171 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,919 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 237 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00340171 reports 2 study locations spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00340171 about?

NCT00340171 is a clinical study titled "Fetal Growth Evaluation by Three-Dimensional Ultrasound". 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 rec...

What is the current status of trial NCT00340171?

This trial is currently completed. The enrollment target is 1,919 participants. The study started on 1997-12-04. Estimated completion is 2012-11-05.

What conditions does trial NCT00340171 study?

This clinical trial studies the following conditions: Pregnancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT00340171?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 237 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00340171 being conducted?

This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial