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"Fetal gRowth AbnorMality dEtection Trial"

Study acronym: FRAME
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Oct 20, 2022 to Oct 20, 2025
    • Start date changed from estimate of Oct 20, 2021 to Jan 20, 2024
    • Study sites: 2 to 3
    • Study completion date: Dec 20, 2022 to Dec 21, 2025
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05043753
Lead Sponsor University of Modena and Reggio Emilia
Conditions
(from sponsor)		 Small for Gestational Age Infant, Large for Gestational Age Infant, Oligohydramnios, Polyhydramnios
Related terms Oligohydramnios, Polyhydramnios
Enrollment 1,566 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov