Growth ChartsMETRICSNCT05774912
Development of Italian Fetal Growth Charts
An observational study of Growth Charts, run by IRCCS Burlo Garofolo at 3 sites in Italy.
Trial summary
There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Growth Charts
- What is being tested?
- Ultrasound evaluation
- How many people
- 2,500 participants
- Where
- 3 sitesItaly
- Study dates
- 26 Apr 2021to 31 Dec 2024
- 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 18 to 40 years
- Women only
- Adult
Study population: Healthy women with singleton uncomplicated pregnancy
Who may be able to join
- Age >18 years and ≤40 years
- body mass index (BMI) 18-30 kg/m2
- singleton pregnancy
- the first day of the last menstrual period (LMP) known and the cycle reported to be regular, lasting 28 days ±4 days and a crown rump length (CRL) measured in early pregnancy
- no history of chronic health problems
- no long-term medication (including fertility treatment)
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- no environmental or economic constraints likely to impede fetal growth
- not smoking currently or in the previous 6 months
- no alcohol consumption
- no history of recurrent miscarriages
- no previous preterm delivery (<37 week) or birthweight < 2,500 grams
- no evidence in the present pregnancy of congenital disease or fetal anomaly at study entry
Who cannot join
- multiple pregnancy
- fetuses with congenital structural or chromosomal anomalies including increased nuchal translucency (>99°centile)
- fetal death
- women with disorders that may affect fetal growth (pre-existing hypertension, diabetes mellitus, renal disease)
- drug assumption (low dose aspirin, etc)
- smoking
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- delivery <37 weeks
- pregnancy complications (hypertensive disorders of pregnancy, infections, gestational diabetes, other diseases)
- pregnancies conceived by assisted reproductive technology
- Abnormal uterine arteries Doppler (if performed)
- First trimester PAPP-A<0.3 MoM
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Not yet recruiting
Fondazione IRCSS Ca Granda, Policlinico di Milano
Milan, Lombardy, 20122
Enrico Ferrazzi, MD, +39 0255031, enrico.ferrazzi@unimi.it
- Not yet recruiting
Fondazione Policlinico Agostino Gemelli - IRCCS City Rome
Rome, Lazio, 00168
Alessandra Familiari, MD, +39 0630151, alessandra.familiari@policlinicogemelli.it
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Tamara Stampalija, MD, 0403785486, tamara.stampalija@burlo.trieste.it
About this study
Official title: Fetal Growth Curves and Doppler Velocimetry in the Italian Population, Multicenter Study
There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Indeed, methodological aspects such as the study population, data collection, curve modeling and others are of crucial importance for the final outcome of the process. Beside the discussion on methodological issues, there is also an ongoing discussion regarding whether one international standard might be adequate to assess fetal growth all around the globe, or are there some differences related to ethnicity supporting the adoption of growth charts constructed based on national data, or even the customization. Recently, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) Practice Guidelines on Ultrasound Assessment of Fetal Biometry and Growth recommended the application of "prescriptive biometry charts, obtained prospectively, truly population-based and derived from studies with the lowest possible methodological bias", and called for the practitioners' awareness regarding national or even local reference charts. Such awareness requires an exploratory and preliminary analysis of the impact of different charts by applying reference values to local findings.
On these grounds, there is an urgent need for a nationwide study for the prospective collection of data and the construction of methodologically robust national growth and Doppler standards.
Read the detailed description
There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Indeed, methodological aspects such as the study population, data collection, curve modeling and others are of crucial importance for the final outcome of the process. Beside the discussion on methodological issues, there is also an ongoing discussion regarding whether one international standard might be adequate to assess fetal growth all around the globe, or are there some differences related to ethnicity supporting the adoption of growth charts constructed based on national data, or even the customization.
Recently, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) Practice Guidelines on Ultrasound Assessment of Fetal Biometry and Growth recommended the application of "prescriptive biometry charts, obtained prospectively, truly population-based and derived from studies with the lowest possible methodological bias", and called for the practitioners' awareness regarding national or even local reference charts. Such awareness requires an exploratory and preliminary analysis of the impact of different charts by applying reference values to local findings.
A recent multicentric Italian study promoted by the Italian Society of Ultrasound in Obstetrics and Gynecology (SIEOG), assessed the application of WHO growth charts published in 2006 and the Intergrowth 21 (IG-21st) growth charts in a large Italian cohort (n=7347) of low risk women with uneventful pregnancy. According to the results of the study the IG-21st standards identified the smallest proportion of fetuses below the 10th centile and the largest proportion of fetuses above the 90th centile, respectively. The proportion of fetuses with head circumference (HC), abdominal circumference (AC) and femur length (LF) above 90th centile was 29.9%, 32.5 and 46%, respectively. While the WHO references seem to be the closest to observed 10th centile, the proportion of fetuses above 90th centile was also higher than expected for an appropriate distribution of centiles, but smaller compared with IG-21st standards: 22.8%, 21.3% and 31.9% for HC, AC and LF, respectively. Overall, these data suggest that there might be differences linked to ethnic origin and not fully explained by maternal, socio-economic or other methodological factors as already suggested by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and World Health Organization (WHO) groups.
These data suggest that, despite indisputable advantages that IG-21st growth standards might offer, immediate application into clinical practice might result into an under-diagnosis of small for gestational age fetuses and, especially, in an over-diagnosis of large for gestational age fetuses with major consequences for clinical practice. The WHO growth references seem to be more suitable for our population, although they might also over-estimate the proportion of large for gestational age fetuses. On the other hand, existing national growth charts lack crucial biometric parameters and centiles. This is of major importance, if we consider that recent consensus criteria suggested AC and estimated fetal weight (EFW) below the 3rd centile as independent criteria for the diagnosis fetal growth restriction.
On these grounds, there is an urgent need for a nationwide study for the prospective collection of data and the construction of methodologically robust national growth and Doppler standards.
- Conditions
- Growth Charts
- Being tested
- Ultrasound evaluation
- Keywords
- Fetal growth charts, Doppler, biometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound evaluationOther
Fetal ultrasound evaluation will be collected longitudinally during the prenatal period from the weeks 14 every 4-5 weeks, for a total of maximum 6 ultrasound scans
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Healthy women with singleton uncomplicated pregnancy Receives: Other: Ultrasound evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal growth evaluation
Construction of national normal fetal growth reference charts
Measured: From the weeks 14 of gestational age to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start26 Apr 2021
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth ChartsStudies 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
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Stampalija, Study chair, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774912
- Sponsor's protocol ID
- RC 24/20
- Acronym
- METRICS
- Status last verified
- Jun 2023
- First submitted
- 3 Mar 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Growth Curves and Doppler Velocimetry in the Italian Population, Multicenter Study
- ClinicalTrials.gov ID
- NCT05774912
- Acronym / sponsor ID
- METRICS / RC 24/20
- Conditions
- Growth Charts
- Keywords
- Fetal growth charts, Doppler, biometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 2023 (actual)
- 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.
There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Indeed, methodological aspects such as the study population, data collection, curve modeling and others are of crucial importance for the final outcome of the process. Beside the discussion on methodological issues, there is also an ongoing discussion regarding whether one international standard might be adequate to assess fetal growth all around the globe, or are there some differences related to ethnicity supporting the adoption of growth charts constructed based on national data, or even the customization. Recently, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) Practice Guidelines on Ultrasound Assessment of Fetal Biometry and Growth recommended the application of "prescriptive biometry charts, obtained prospectively, truly population-based and derived from studies with the lowest possible methodological bias", and called for the practitioners' awareness regarding national or even local reference charts. Such awareness requires an exploratory and preliminary analysis of the impact of different charts by applying reference values to local findings.
On these grounds, there is an urgent need for a nationwide study for the prospective collection of data and the construction of methodologically robust national growth and Doppler standards.
Detailed description
There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Indeed, methodological aspects such as the study population, data collection, curve modeling and others are of crucial importance for the final outcome of the process. Beside the discussion on methodological issues, there is also an ongoing discussion regarding whether one international standard might be adequate to assess fetal growth all around the globe, or are there some differences related to ethnicity supporting the adoption of growth charts constructed based on national data, or even the customization.
Recently, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) Practice Guidelines on Ultrasound Assessment of Fetal Biometry and Growth recommended the application of "prescriptive biometry charts, obtained prospectively, truly population-based and derived from studies with the lowest possible methodological bias", and called for the practitioners' awareness regarding national or even local reference charts. Such awareness requires an exploratory and preliminary analysis of the impact of different charts by applying reference values to local findings.
A recent multicentric Italian study promoted by the Italian Society of Ultrasound in Obstetrics and Gynecology (SIEOG), assessed the application of WHO growth charts published in 2006 and the Intergrowth 21 (IG-21st) growth charts in a large Italian cohort (n=7347) of low risk women with uneventful pregnancy. According to the results of the study the IG-21st standards identified the smallest proportion of fetuses below the 10th centile and the largest proportion of fetuses above the 90th centile, respectively. The proportion of fetuses with head circumference (HC), abdominal circumference (AC) and femur length (LF) above 90th centile was 29.9%, 32.5 and 46%, respectively. While the WHO references seem to be the closest to observed 10th centile, the proportion of fetuses above 90th centile was also higher than expected for an appropriate distribution of centiles, but smaller compared with IG-21st standards: 22.8%, 21.3% and 31.9% for HC, AC and LF, respectively. Overall, these data suggest that there might be differences linked to ethnic origin and not fully explained by maternal, socio-economic or other methodological factors as already suggested by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and World Health Organization (WHO) groups.
These data suggest that, despite indisputable advantages that IG-21st growth standards might offer, immediate application into clinical practice might result into an under-diagnosis of small for gestational age fetuses and, especially, in an over-diagnosis of large for gestational age fetuses with major consequences for clinical practice. The WHO growth references seem to be more suitable for our population, although they might also over-estimate the proportion of large for gestational age fetuses. On the other hand, existing national growth charts lack crucial biometric parameters and centiles. This is of major importance, if we consider that recent consensus criteria suggested AC and estimated fetal weight (EFW) below the 3rd centile as independent criteria for the diagnosis fetal growth restriction.
On these grounds, there is an urgent need for a nationwide study for the prospective collection of data and the construction of methodologically robust national growth and Doppler standards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Ultrasound evaluationHealthy women with singleton uncomplicated pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Healthy women with singleton uncomplicated pregnancy
Key inclusion criteria (12 listed)
- Age >18 years and ≤40 years
- body mass index (BMI) 18-30 kg/m2
- singleton pregnancy
- the first day of the last menstrual period (LMP) known and the cycle reported to be regular, lasting 28 days ±4 days and a crown rump length (CRL) measured in early pregnancy
- no history of chronic health problems
Key exclusion criteria (11 listed)
- multiple pregnancy
- fetuses with congenital structural or chromosomal anomalies including increased nuchal translucency (>99°centile)
- fetal death
- women with disorders that may affect fetal growth (pre-existing hypertension, diabetes mellitus, renal disease)
- drug assumption (low dose aspirin, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound evaluationFetal ultrasound evaluation will be collected longitudinally during the prenatal period from the weeks 14 every 4-5 weeks, for a total of maximum 6 ultrasound scans | Other | Pregnant women |
Primary outcome
Fetal growth evaluation
Time frame: From the weeks 14 of gestational age to delivery
Construction of national normal fetal growth reference charts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Tamara Stampalija study chair
Institute for Maternal and Child Health IRCCS Burlo Garofolo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Charts, run by IRCCS Burlo Garofolo at 3 sites in Italy.
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 12 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamara Stampalija, MD (+390403785486, tamara.stampalija@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal growth evaluation (time frame: From the weeks 14 of gestational age to delivery). 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 13 Jun 2024.