A First Trimester Prediction Model for Large for Gestational Age Infants: a Preliminary Study

NCT04838431 | Terminated

• 1 other identifier: AOU: 0001395/20
• Study Type: observational
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

Large for gestational age infants (LGA) have increased risks of adverse short-term perinatal outcomes. This study aims to develop a multivariable prediction model for the risk of giving birth to a LGA baby, by using biochemical, biophysical, anamnestic, and clinical maternal characteristics available at first trimester. This prospective study includes all singleton pregnancies attending the first trimester aneuploidy screening at the Obstetric Unit of the University Hospital of Modena, in Northern Italy.

Conditions

Large for Gestational Age Baby; Macrosomia, Fetal

Keywords

Prediction model; LGA; Singleton; Birtweight

Outcome Measures

Primary Outcomes (1)

• LGA

  Risk for delivering a LGA infant, by combining the birtweight, the infant gender and the gestational age at birth

  From 37-42 weeks

Interventions

Blood sample and ultrasound at first trimester OTHER

The blood sample and the ultrasound are part of the routine care for the aneuploidy screening at first trimester. We deepened the biochemicals and biophysical markers for predicting the risk for large for gestational age infants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).

You may qualify if:

• Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).

You may not qualify if:

• Twin pregnancies
• Pregnancies with major fetal abnormalities

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

University Hospital of Modena

Modena, 41124, Italy

Location

Related Publications (1)

• Monari F, Menichini D, Spano' Bascio L, Grandi G, Banchelli F, Neri I, D'Amico R, Facchinetti F. A first trimester prediction model for large for gestational age infants: a preliminary study. BMC Pregnancy Childbirth. 2021 Sep 24;21(1):654. doi: 10.1186/s12884-021-04127-3.

  PMID: 34560843 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

For each subject, blood sample is collected in fasting conditions for biochemical analyses of PAPP-A, PlGF, Inibin A, Insulin, high density lipoproteins (HDL) and triglycerides (TG), measured through routine laboratory methods.

MeSH Terms

Conditions

Fetal Macrosomia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fabio R Facchinetti, MD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Obstetrics and Gynecolocy department

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: June 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

IT (1)