Pregnant women
Conditions
Interventions
None listed
Sponsors
katsura daisuke
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnant women aged 18 years or older at enrollment, at 22 weeks of gestation or later, who fully understand the study procedures and provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients will be excluded if the fetus has severe fetal anomalies, chromosomal abnormalities, or genetic abnormalities; if the attending physician judges participation in the study to be inappropriate; or if the mother or fetus requires emergency management, such as for umbilical cord prolapse, fetal-placental dysfunction, massive genital bleeding due to placenta previa, uterine rupture, or other urgent maternal or fetal conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predictive ability of NGAL and L-FABP levels in amniotic fluid at delivery and in neonatal urine after birth for neonatal death (death within 28 days after birth), infant death, and neurological sequelae at 2 years of age, including cerebral palsy and developmental delay (developmental quotient <85 on the Kyoto Scale of Psychological Development). | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between NGAL and L-FABP levels in amniotic fluid at delivery and those in neonatal urine after birth. Correlation between NGAL and L-FABP levels in amniotic fluid at delivery and those in umbilical cord blood. Association of each biomarker with adverse perinatal outcomes, including NICU admission, respiratory distress syndrome, mechanical ventilation, neonatal sepsis, necrotizing enterocolitis, and intraventricular hemorrhage. Comparison of the predictive ability of amniotic fluid biomarkers and neonatal urinary biomarkers based on the area under the curve in ROC analysis. Correlations of beta2-microglobulin and cystatin C with NGAL and L-FABP, and their associations with adverse perinatal outcomes. | — |
Contacts
Public ContactDaisuke katsura
Shiga University of Medical Science Hospital
Outcome results
None listed