Development of Italian Fetal Growth Charts

NCT05774912 | Unknown

• 1 other identifier: RC 24/20
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Growth Charts

Keywords

Fetal growth charts; Doppler; biometry

Outcome Measures

Primary Outcomes (1)

• Fetal growth evaluation

  Construction of national normal fetal growth reference charts

  From the weeks 14 of gestational age to delivery

Study Arms (1)

Pregnant women

Healthy women with singleton uncomplicated pregnancy

Other: Ultrasound evaluation

Interventions

Ultrasound evaluation OTHER

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

Pregnant women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women with singleton uncomplicated pregnancy

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (3)

Fondazione Policlinico Agostino Gemelli - IRCCS City Rome

Rome, Lazio, 00168, Italy

NOT YET RECRUITING

Fondazione IRCSS Ca Granda, Policlinico di Milano

Milan, Lombardy, 20122, Italy

NOT YET RECRUITING

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

RECRUITING

Study Officials

• Tamara Stampalija

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  STUDY CHAIR

Central Study Contacts

Tamara Stampalija, MD

CONTACT

+390403785486; tamara.stampalija@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 20, 2023
• Study Start: April 26, 2021
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2023-06

Locations

IT (3)