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MRI study of the brain condition of babies during pregnancy

Establishment of a Novel Fetal Brain Functional Assessment Method Using MRI in Fetuses with Growth Restriction - FGR-BrainMRI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050250125
Enrollment
120
Registered
2025-10-02
Start date
2025-10-02
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

Fetal growth restriction

Interventions

None listed

Sponsors

Katsura Daisuke
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Severe FGR group Pregnant women at more than 26 weeks of gestation whose estimated fetal weight is less than or equal to -1.5 SD and who meet at least one of the following criteria: Estimated fetal weight less than or equal -2.0 SD Oligohydramnios Abnormal fetal blood flow Control group: Pregnant women at more than 26 weeks of gestation without fetal growth restriction, who undergo MRI for maternal indications. Maternal indications include: Uterine myoma Adenomyosis Ovarian tumor Placental abnormalities (placenta previa, placental tumor, placental hematoma) Umbilical cord abnormalities (abnormal cord insertion, single umbilical artery, cord torsion abnormality) Age 18 years or older at enrollment. The patient must fully understand the procedure and provide informed consent.

Exclusion criteria

Exclusion criteria: Fetuses with brain malformations, severe congenital anomalies, chromosomal abnormalities, or multiple pregnancies. Patients judged by the attending physician to be unsuitable for participation in this study. Cases with umbilical cord prolapse, fetal-placental dysfunction, massive genital bleeding due to placenta previa, uterine rupture, or other maternal/fetal conditions requiring emergency management. Patients with contraindications to MRI.

Design outcomes

Primary

MeasureTime frame
Differences in ADC values and concentrations of NAA, Cho, Cr, Glu, and Lac according to the presence or absence of fetal death, neonatal death (death within 28 days after birth), infant death, or neurodevelopmental sequelae at 2 years of age (cerebral palsy, severe developmental delay defined as a developmental quotient <70 on the Kyoto Scale of Psychological Development).

Secondary

MeasureTime frame
Differences in ADC values and concentrations of NAA, Cho, Cr, Glu, and Lac according to the presence or absence of neonatal intensive care unit admission, respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity, intracranial hemorrhage, periventricular leukomalacia, need for mechanical ventilation, uncorrectable visual impairment at 2 years of age, or hearing impairment requiring a hearing aid.

Contacts

Public ContactDaisuke Katsura

Shiga University of Medical Science Hospital

hqgyne@belle.shiga-med.ac.jp+81-775482267

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026