N/A N=813 Randomized Single-blind Screening

Third Trimester Screening of Fetal Growth Restriction

Fetal Growth Retardation · Fetal; Slow Growth

Bottom Line

View on ClinicalTrials.gov: NCT05787054 ↗

Enrolled (actual)

813

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Rate of Small for Gestational Age at Birth Identified Antenatally — 28; 46 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Third trimester ultrasound (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Small for Gestational Age at Birth Identified Antenatally	28; 46	—
SECONDARY Rate of Cesarean Section in the Two Groups	84; 76	—
SECONDARY Rate of Adverse Outcomes	15; 4	—

Summary

The aim of this trial is to assess the efficacy of two screening protocols for the detection of fetal growth disorders. In Italy at the moment the screening protocol should not be universal but only on clinical indications. In some Regions the screening is offered to every pregnant women with an early third trimester scan at 28-32 weeks'gestation or, in other Regions, according to the new national recommandations, a growth scan during the third trimester is provided only if there is a clinical indication.

Eligibility Criteria

Inclusion Criteria

Eligible cases are nulliparous pregnant women, with first trimester ultrasound assessment of gestational age, who conceived singleton fetuses. If the crown-rump-length (CRL) differs of more than ± 3-5 days from the last menstrual period, gestational age is calculated on the CRL.

Exclusion Criteria

major medical disease
high risk for preeclampsia on history or detected in those centres that perform pre-eclampsia screening at first trimester
women older than 40 years on ASA low dose prophylaxis
known immune disorders or clinical thrombophilic conditions;
twin pregnancies;
IVF
suspected fetal anomalies at any gestational age
Papp-A at Combined-Test<0.2

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05787054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.