PregnancyNCT00340171
Fetal Growth Evaluation by Three-Dimensional Ultrasound
An observational study of Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- How many people
- 1,919 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 1997to 5 Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women aged 18 years and older attending clinics at the Hutzel Women's Hospital in Detroit.
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
Show all 10Show fewer
- INFANT BODY COMPOSITION STUDY
- Infants requiring mechanical ventilation, heart monitors, or intravenous fluid.
- Hemodynamically unstable infant
- Infants with thermoregulation problems
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hutzel Women's Hospital
Detroit, Michigan, 48201
William Beaumont Hospital
Royal Oak, Michigan
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- Intrauterine Growth Retardation, Natural History
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women and infants | pregnant women with singleton pregnancy and their newborns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrauterine fetal growth restriction
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start4 Dec 1997
- Primary completion5 Nov 2012
- Study completion5 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Roberto Romero, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340171
- Sponsor's protocol ID
- 999997068
- Other IDs
- OH97-CH-N068
- Status last verified
- Feb 2023
- First submitted
- 19 Jun 2006
- Last updated
- 24 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Growth Evaluation by Three-Dimensional Ultrasound
- ClinicalTrials.gov ID
- NCT00340171
- Acronym / sponsor ID
- 999997068
- Conditions
- Pregnancy
- Keywords
- Intrauterine Growth Retardation, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,919 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 4 Dec 1997 (actual)
- Primary completion
- 5 Nov 2012 (actual)
- Study completion
- 5 Nov 2012 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women and infants | – | –pregnant women with singleton pregnancy and their newborns |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women aged 18 years and older attending clinics at the Hutzel Women's Hospital in Detroit.
Key inclusion criteria (13 listed)
- Pregnant women between the ages of 18 and 40 years at Hutzel and William Beaumont Hospital sites.
- Single gestation.
- No pregnancy complications.
- Accurate dating criteria (sure LMP or first trimester scan).
- Singe Gestation.
Key exclusion criteria (10 listed)
- Poor visualization of the fetus due to technical factors (e.g. obesity).
- Risk factors that increase risk for not keeping serial ultrasound appointments.
- Poor visualization of the fetus due to technical factors (e.g. obesity).
- Hemodynamically unstable patients.
- INFANT BODY COMPOSITION STUDY
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intrauterine fetal growth restriction
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Romero, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine fetal growth restriction (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.