"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

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

Treatments tested in this trial

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

Treatment groups

1,566 Participants
are divided into 2 treatment groups