臨床研究等提出・公開システム

Date of registration	June. 09, 2026
Last modified on	June. 09, 2026
Trial ID	jRCT1050260071

Scientific Title	Comparative Evaluation of Amniotic Fluid and Neonatal Urinary NGAL and L-FABP for Predicting Perinatal Outcomes: A Prospective Observational Study (AFNU Biomarker Study)
Public Title	A study to predict perinatal outcomes using biomarkers in amniotic fluid and neonatal urine

Contact for Scientific Queries	Name	katsura daisuke
	Affiliation	Shiga University of Medical Science Hospital
	Address	Seta Tsukinowa-cho, Otsu, Shiga
	Telephone	+81-775482267
	E-mail	katsuo14@belle.shiga-med.ac.jp
Contact for Public Queries	Name	katsura Daisuke
	Affiliation	Shiga University of Medical Science Hospital
	Address	Seta Tsukinowa-cho, Otsu, Shiga
	Telephone	+81-775482267
	E-mail	hqgyne@belle.shiga-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 09, 2026
Target sample size		200
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	diagnostic purpose
Key inclusion & exclusion 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	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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Pregnant women
Health Condition(s) Code		D011247
Primary Outcome(s)		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(s)		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.

Primary Sponsor	none

Secondary Sponsor

Name of Certified Review Board	Shiga University of Medical Science Clinical Research Review Board
Address	Seta Tsukinowa-cho, Otsu, Shiga, Shiga
Telephone	+81-77-548-3576
E-Mail	hqrec@belle.shiga-med.ac.jp
Approval Status	Approval
Date of approval	June. 05, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none