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"Fetal GRowth AbnorMality DEtection Trial"

NCT05043753 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1566

Last updated 2024-12-09

No results posted yet for this study

Summary

The present trial intends to assess the diagnostic accuracy of symphysis fundal height (SFH) as opposed to SFH combined with point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC) in identifying small and large for gestational age infants (SGA and LGA infants) among low-risk pregnant women cared for by midwives after 35 weeks' gestation.

Low risk pregnancies will be evaluated at 35-38, 40, 41, and 41+ weeks' gestation by midwives trained in SFH measurement and POC-US. Formal obstetric US performed by a perinatologist (i.e high risk obstetrician) will be performed in case SFH and/or POC-US suspect fetal growth or amniotic fluid abnormalities. Prenatal evaluations will be compared to actual birthweights.

Conditions

  • Small for Gestational Age Infant
  • Large for Gestational Age Infant
  • Oligohydramnios
  • Polyhydramnios

Interventions

OTHER

Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC)

Midwives perform a POC-US to measure the fetal abdominal circumference (AC) and evaluate the quantity of amniotic fluid. In order to identify the appropriate sonographic plane the following markers need to be identified on POC-US * Fluid filled fetal stomach on the left. * Umbilical vein * Umbilical portion of left portal vein within liver, as it meets the "pars transversa" (horizontal portion of left portal vein) seen as a right sided " L " or " C " shape. * Fetal spine seen in cross section Amniotic fluid volume will be evaluated determining the deepest vertical pocket (DVP). Measurement is performed by assessing a pocket of maximal depth of amniotic fluid free of umbilical cord and fetal parts. The transducer is held perpendicularly to the patient's abdomen. The absence of a pocket measuring at least 2 cm in depth and 1 cm in width is indicative of oligohydramnios, while detection of a pocket measuring 8 cm or larger is suggestive of polyhydramnios (ACOG bulletin 175, 2016).

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    lead OTHER

Principal Investigators

  • Giuseppe Chiossi, MD · University of Modena and Reggio Emilia, Modena Policlinico Hospital, Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-20
Primary Completion
2025-10-20
Completion
2025-12-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043753 on ClinicalTrials.gov