About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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, accreta, percreta), uterine fibroids.
Trial design
Parallel
Treatments tested in this trial
Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC)
Other interventionMidwives 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).
Treatment groups
Trial outcomes
Primary outcomes
Number of prenatally identified fetuses that will be classified as small or large for gestational age as infants (SGA and LGA infants)
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.
Secondary outcomes
Number of formal obstetric ultrasound (US) requested due to abnormal fetal growth or amniotic fluid suspected prenatally
Formal obstetric ultrasound are the ones performed by trained perinatologists in the prenatal diagnosis department
Number of cases of oligohydramnios and polyhydramnios identified on formal obstetric US after being suspected on prenatal evaluation
Formal obstetric ultrasound are the ones performed by trained perinatologists in the prenatal diagnosis department
Number of deliveries indicated by amniotic fluid or fetal growth abnormalities detected on formal obstetric US
Indicated deliveries are inductions of labor or cesarean deliveries performed in non-laboring women due to amniotic fluid or fetal growth abnormalities
Number of adverse neonatal outcome cases
Adverse neonatal outcomes are summarized as a composite of neonatal death, non-invasive (cPAP) or invasive (mechanical ventilation) respiratory support, hypoglycemia (\< 44 mg/dl needing therapy), newborn sepsis, confirmed seizures, stroke, intraventricular hemorrhage (IVH), basal nuclei anomalies, cardiopulmonary resuscitation, umbilical-cord-blood arterial pH \< 7.0 or base excess \< -12.5, prolonged hospitalization (\> 5 days), or shoulder dystocia
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