"Fetal gRowth AbnorMality dEtection Trial"

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Modena and Reggio Emilia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC)

    Other intervention

    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).

Treatment groups

1,566 Participants
are divided into 2 treatment groups
Group A: Control group: Symphysis fundal height measurementNo intervention 0 interventions
Group B: intervention group: Symphysis fundal height measurement and point of care ultrasound.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Secondary outcomes

1

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

Time frame
From enrollment through study completion, an average of 1 year. Formal obstetric ultrasound will be requested in case of suspicion of abnormal fetal growth or amniotic fluid on screening with symphysis fundal height associated or not to POC ultrasound
2

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

Time frame
From enrollment through study completion, an average of 1 year. Formal obstetric ultrasound will be requested in case of suspicion of abnormal fetal growth or amniotic fluid on screening with symphysis fundal height associated or not to POC ultrasound
3

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

Time frame
At the time of delivery, from enrollment through study completion, an average of 1 year
4

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

Time frame
At the time of delivery, from enrollment through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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