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Recruiting NCT05043753

"Fetal GRowth AbnorMality DEtection Trial"

Trial Parameters

Condition Small for Gestational Age Infant
Sponsor University of Modena and Reggio Emilia
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,566
Sex FEMALE
Min Age 18 Years
Max Age 45 Years
Start Date 2024-01-20
Completion 2025-10-20
Interventions
Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC)

Brief 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 Criteria

Inclusion Criteria: * Maternal age ≥ 18 years and ability to give informed consent. * Singleton gestation * Ultrasound examination that confirms or revises the EDD before 14 weeks of gestational age * Gestational age ≥ 35 weeks' gestation * Normal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT) when performed * Spontaneously conceived pregnancy (i.e the current pregnancy is not the result of in vitro fertilization) Exclusion Criteria: * Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis is performed * Fetal malformations or soft markers identified on fetal anatomy survey * Episodes of uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criteria. * Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accre

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