Clinical Trial

"Fetal gRowth AbnorMality dEtection Trial"

Study acronym: FRAME
Recruiting
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Record status
This record was last updated December 9, 2024 (before its estimated October 20, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-09-13.
Status change: Not Yet Recruiting → Recruiting 2024-12-04
Trial Details
NCT Number NCT05043753
Lead Sponsor University of Modena and Reggio Emilia
Conditions Small for Gestational Age Infant, Large for Gestational Age Infant, Oligohydramnios, Polyhydramnios
Enrollment 1,566 participants
Start Date 2024-01-20
Primary Completion 2025-10-20 (estimated)
Study Completion 2025-12-21 (estimated)
Updated on ClinicalTrials.gov 2024-12-09