NIPH Clinical Trials Search

A study to predict perinatal outcomes using biomarkers in amniotic fluid and neonatal urine

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Pregnant women
Date of first enrollment	09/06/2026
Target sample size	200
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

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