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Study on Prenatal Blood and Urine Biomarkers for Fetal Hypospadias

Screening of Blood and Urine Biomarkers and Mechanism Exploration in Pregnant Women with Fetal Hypospadias Suspected by Prenatal Ultrasound

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128117
Enrollment
Unknown
Registered
2026-07-14
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Interventions

Case group:None
Control group:None

Sponsors

Chongqing Health Center for Women and Children
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Case Group 1. At least one systematic ultrasound examination during the second trimester (18 to 28 weeks) indicates a suspected hypospadias in the fetus (including any of the following soft ultrasound indicators: short penis with a rounded tip, ventral curvature of the penis, positive "tulip sign", abnormal urination direction, etc.); 2. Singleton pregnancy 3. Plan to continue the pregnancy and give birth in our hospital. Control group Prenatal ultrasound examination was conducted simultaneously, and no abnormalities were found in the fetal external genitalia. 2. Singleton pregnancy 3. Plan to continue the pregnancy and give birth in our hospital; 4. Individual matching was conducted based on the age (+/-3 years) and gestational age (+/-1 week) of the pregnant women in the case group.

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancies; 2. The fetus is combined with other definite structural malformations (such as congenital heart disease, neurological malformations, cleft lip and palate, etc.); 3. The fetus is diagnosed with chromosomal abnormalities (such as abnormal karyotype analysis or CNV-seq results); 4. Pregnant women suffer from severe pregnancy complications (such as severe preeclampsia, gestational diabetes requiring insulin treatment, severe autoimmune diseases, etc.).

Design outcomes

Primary

MeasureTime frame
The expression profile characteristics of metabolites in the serum and urine of pregnant women;The list and quantitative results of differential metabolites/proteins between the confirmed group and the control group;Diagnostic efficacy indicators of differential molecules: sensitivity, specificity, positive predictive value, negative predictive value, area under the curve (AUC);Clinical physical examination of newborns;

Secondary

MeasureTime frame
The correlation between the differential molecular level and the severity of hypospadias (urethral orifice location classification);Distribution characteristics of differential molecules in the ultrasound false positive group;The core metabolic pathways involved in key differential metabolites and their biological significance;Clinical information (baseline information of pregnant women, prenatal ultrasound during follow-up, postpartum information, neonatal information);

Countries

China

Contacts

Public ContactGuo Chunbao

Chongqing Health Center for Women and Children

guochunbao@hospital.cqmu.edu.cn+86 23 60354527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026