Observational Study on Fetal Growth Restriction Complicated by Early Flowmetric Alterations

NCT06717555 | Completed

• 1 other identifier: ARDEF
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to to understand whether the presence of flowmetric alterations in association with early growth retardation (i.e., before 22 weeks gestational age) is associated with worse neonatal and maternal outcomes than intrauterine growth retardation arising later in life.

Conditions

Fetal Growth Restriction (FGR)

Keywords

flowmetric alterations; FGR

Outcome Measures

Primary Outcomes (1)

• Collecting outcomes of pregnancies complicated by growth restriction and early-onset flowmetric alterations

  To collect the outcomes of pregnancies complicated by growth restriction and early-onset flowmetric alterations, at prenatal ultrasound, to obtain information useful for counseling these patients (for patients in the retrospective part, from 2005 to the present). To analyze the presence of any correlations between different outcomes in this subpopulation of patients with hemodynamic changes (in terms of central and peripheral resistances) of patients and fetuses in pregnancies complicated by placental insufficiency and fetal growth restriction (for patients in the prospective part up to December 2026).

  During prenatal ultrasound

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study group will consist of patients with single pregnancies complicated by intrauterine growth restriction, who access the Pregnancy at Risk Outpatient Clinic, of the Division of Obstetrics and Prenatal Medicine of Policlinico Sant'Orsola to perform the specific diagnostic-care pathway.

You may qualify if:

• Age \> 18 years
• Single pregnancy
• Ultrasound monitoring and delivery at Policlinico S. Orsola in Bologna, Italy
• Acquisition of informed consent form

You may not qualify if:

• \- Desire to perform Voluntary Interruption of Pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

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

Study Officials

• Giuliana Simonazzi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: May 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

IT (1)