Creating Italian Fetal Growth Charts

Fetal Growth Curves and Doppler Velocimetry in the Italian Population, Multicenter Study

This study is trying to create new fetal growth charts specifically for Italian pregnancies to see how they compare to existing charts and better reflect local growth patterns.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: IRCCS Burlo Garofolo (Academic / other)
• Locations: 3 sites (Roma, Lazio and 2 other locations)
• Trial ID: NCT05774912 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop standardized fetal growth charts specific to the Italian population. It addresses the variability in existing growth charts and evaluates the impact of different methodological approaches on fetal growth assessment. The study involves ultrasound evaluations and focuses on establishing reference values that reflect local population characteristics. By analyzing data from singleton pregnancies, the study seeks to provide insights into the appropriateness of national versus international growth standards.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 40 years with a singleton pregnancy and no significant health issues.

Not a fit: Patients with multiple pregnancies, congenital anomalies, or those with conditions affecting fetal growth may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of fetal growth, improving prenatal care and outcomes for mothers and infants.

How similar studies have performed: While there have been discussions on fetal growth standards, this approach is novel in its focus on developing localized charts for the Italian population.

Eligibility criteria

Inclusion Criteria:

1. Age \>18 years and ≤40 years
2. body mass index (BMI) 18-30 kg/m2
3. singleton pregnancy
4. 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
5. no history of chronic health problems
6. no long-term medication (including fertility treatment)
7. no environmental or economic constraints likely to impede fetal growth
8. not smoking currently or in the previous 6 months
9. no alcohol consumption
10. no history of recurrent miscarriages
11. no previous preterm delivery (\<37 week) or birthweight \< 2,500 grams
12. no evidence in the present pregnancy of congenital disease or fetal anomaly at study entry

Exclusion Criteria:

1. multiple pregnancy
2. fetuses with congenital structural or chromosomal anomalies including increased nuchal translucency (\>99°centile)
3. fetal death
4. women with disorders that may affect fetal growth (pre-existing hypertension, diabetes mellitus, renal disease)
5. drug assumption (low dose aspirin, etc)
6. smoking
7. delivery \<37 weeks
8. pregnancy complications (hypertensive disorders of pregnancy, infections, gestational diabetes, other diseases)
9. pregnancies conceived by assisted reproductive technology
10. Abnormal uterine arteries Doppler (if performed)
11. First trimester PAPP-A\<0.3 MoM

Where this trial is running

Roma, Lazio and 2 other locations

• Fondazione Policlinico Agostino Gemelli - IRCCS City Rome — Roma, Lazio, Italy (Not_yet_recruiting)
• Fondazione IRCSS Ca Granda, Policlinico di Milano — Milano, Lombardia, Italy (Not_yet_recruiting)
• Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)

Study contacts

• Study coordinator: Tamara Stampalija, MD

Conditions Growth Charts; Fetal growth charts; Doppler; biometry