"Fetal gRowth AbnorMality dEtection Trial"
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
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.
Eligibility
Primary outcome measure(s)
- Number of prenatally identified fetuses that will be classified as small or large for gestational age as infants (SGA and LGA infants) — From enrollment through study completion, an average of 1 year. Prenatal evaluation of fetal growth and amniotic fluid volume will be performed at 35-38, 40,41, and 41+ weeks' gestation. Infants' weights will be evaluated at birth
Birthweight percentile will be classified according to the INeS neonatal charts (Bertino 2010) to identify SGA (birthweight \< 10th percentile) , LGA (birthweight \> 90th percentile) and AGA (appropriate for gestational age, whose birthweight ranges between the 10th and the 90th percentile) infants.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Policlinico di Modena | Modena | Modena | Recruiting |
| Cesena Hospital | Cesena | Italy | Not Yet Recruiting |
| Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery, Monza, Italy. | Monza | Italy | Not Yet Recruiting |
More University of Modena and Reggio Emilia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05043753 on ClinicalTrials.gov ↗ ← All trials in Italy