A Study on the Accuracy of Criteria for Fetal Growth Restriction

Evaluation of Diagnostic Criteria for Fetal Growth Restriction Using Doppler Ultrasound

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030250839

Enrollment

450

Registered

2026-03-25

Start date

2026-03-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SGA, Fetal Growth Restriction

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion Criteria - Pregnant women aged 18 years or older - Diagnosed with fetal SGA or fetal growth restriction (FGR) at or after 22 weeks of gestation - Expected date of delivery determined according to obstetric practice guidelines - Singleton pregnancy - Receiving antenatal care at participating study sites - Able to provide informed consent - Able to provide consent for the collection of neonatal data

Exclusion criteria

Exclusion criteria: Exclusion Criteria - Cases with evident fetal structural abnormalities - Cases with confirmed chromosomal abnormalities diagnosed prenatally - Cases that have undergone fetal therapy, such as amnioinfusion

Design outcomes

Primary

Measure	Time frame
Composite Adverse Perinatal Outcome (CAPO) CAPO is defined as the presence of at least one of the following outcomes: - Fetal death or neonatal death - Severe neonatal morbidity, including any of the following: - Bronchopulmonary dysplasia (BPD) - Intraventricular hemorrhage (IVH), Papile grade III or IV - Cystic periventricular leukomalacia (cystic PVL), corresponding to De Vries grade II or higher (II-IV) on cranial ultrasound - Sepsis (confirmed by positive blood culture) - Necrotizing enterocolitis (NEC) - Severe persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide or extracorporeal membrane oxygenation (ECMO)	—

Measure

Time frame

Composite Adverse Perinatal Outcome (CAPO) CAPO is defined as the presence of at least one of the following outcomes: - Fetal death or neonatal death - Severe neonatal morbidity, including any of the following: - Bronchopulmonary dysplasia (BPD) - Intraventricular hemorrhage (IVH), Papile grade III or IV - Cystic periventricular leukomalacia (cystic PVL), corresponding to De Vries grade II or higher (II-IV) on cranial ultrasound - Sepsis (confirmed by positive blood culture) - Necrotizing enterocolitis (NEC) - Severe persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide or extracorporeal membrane oxygenation (ECMO)

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Secondary

Measure	Time frame
Postnatal SGA diagnosis rate: Differences in the rate of postnatal SGA diagnosis among the three groups (SGA is defined as both birth weight and birth length below the 10th percentile for gestational age based on standard reference values) Cesarean section rate Preterm birth rate Incidence of hypertensive disorders of pregnancy (HDP) Meconium-related ileus requiring neonatal surgery Retinopathy of prematurity (ROP), stage II or higher	—

Measure

Time frame

Postnatal SGA diagnosis rate: Differences in the rate of postnatal SGA diagnosis among the three groups (SGA is defined as both birth weight and birth length below the 10th percentile for gestational age based on standard reference values) Cesarean section rate Preterm birth rate Incidence of hypertensive disorders of pregnancy (HDP) Meconium-related ileus requiring neonatal surgery Retinopathy of prematurity (ROP), stage II or higher

—

Contacts

Public ContactSumito Nagasaki

Toho University Omori Medical Center

sumito.nagasaki@med.toho-u.ac.jp+81-3-3762-4151

Outcome results