Third Trimester Screening of Fetal Growth Restriction

NCT05787054 | Completed Results DMC

• 1 other identifier: 1909
• Study Type: interventional
• Target: 813
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Growth Retardation; Fetal; Slow Growth

Outcome Measures

Primary Outcomes (1)

• Rate of Small for Gestational Age at Birth Identified Antenatally

  Rate of newborns with a Birth Weight \<10 th centile according to International Prescriptive Charts who were prenatally identified

  at birth

Secondary Outcomes (2)

• Rate of Cesarean Section in the Two Groups

  at birth

• Rate of Adverse Outcomes

  up to 40 days after birth

Study Arms (2)

Single scan

ACTIVE COMPARATOR

Single scan at 28-32 weeks

Other: Third trimester ultrasound

Longitudinal scan

EXPERIMENTAL

Longitudinal scan at 28-32 AND 35-37 weeks

Other: Third trimester ultrasound

Interventions

Third trimester ultrasound OTHER

Single scan versus Longitudinal scan

Longitudinal scan; Single scan

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia ostetrica

Rome, RM, 00168, Italy

Location

Related Publications (1)

• Familiari A, Stampalija T, Prefumo F, di Marco G, Ferrante MG, Bevilacqua E, Zamagni G, Monasta L, Tiralongo G, Valensise H, Morlando M, Sarno L, Di Mascio D, Mappa I, Rizzo G, Visentin S, Fichera A, Radaelli T, Thilaganathan B, Scambia G, Ghi T, Ferrazzi E. Single versus longitudinal scans in the third trimester: a multicenter randomized clinical trial on screening for late-onset intrauterine fetal growth restriction (The RCT on Evaluation of LAte Iugr Screening study). Am J Obstet Gynecol. 2025 Nov 21:S0002-9378(25)00858-0. doi: 10.1016/j.ajog.2025.11.027. Online ahead of print.

  PMID: 41276199 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of our study include that the sample size has been calculated to determine the diagnostic effectiveness of the two screening protocols and not on perinatal outcomes - that represent a secondary outcome - thus meaning that possible additional differences in neonatal outcomes could be shown in a larger population, and we did not explore whether the intervention had any effect on long term consequences

Results Point of Contact

• Title: Dr Alessandra Familiari
• Organization: Catholic University of the Sacred Heart, Fondazione Policlinico Gemelli

alessandra.familiari@policlinicogemelli.it

+393285887422

Study Officials

• Alessandra Familiari, MD

  Catholic University of the Sacred Heart, Rome

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 28, 2023
• Study Start: January 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: May 27, 2023
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: When the first publication is ready for submission for one year
• Access Criteria: Only for principal investigators of the recruiting centres

Locations

IT (1)