RecruitingNot ApplicableNCT05043753

"Fetal gRowth AbnorMality dEtection Trial"

Department of Obstetrics and Gynecology Modena Policlinico Hospital Vial Del Pozzo 71, 41125 Modena

Sponsor

University of Modena and Reggio Emilia

Enrollment

1,566 participants

Start Date

Jan 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC) for people with large for gestational age infant, oligohydramnios, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPoint 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).