NIPH Clinical Trials Search

MRI study of the brain condition of babies during pregnancy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Fetal growth restriction
Date of first enrollment	02/10/2025
Target sample size	120
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include 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.
Exclude 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.