Skip to content

The Value of Artificial Intelligence in Predicting FGR During Early Second-Trimester Fetal Ultrasound Screening

The Value of Artificial Intelligence in Predicting FGR During Early Second-Trimester Fetal Ultrasound Screening

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125294
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

fetal growth restriction

Interventions

Gold Standard:The ultrasound diagnostic criteria for FGR formulated by ISUOG guidelines and Delphi consensus were adopted as the gold standard.
Index test:FGR Artificial Intelligence Prediction Model

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Singleton live pregnancy with standardized early-second-trimester ultrasound screening completed in our hospital, with complete ultrasound images and clinical data; 2. Maternal age ranged from 18 to 45 years old, with complete baseline clinical information, pregnancy outcomes and follow-up data; 3. Fetuses with no structural malformations detected by systematic ultrasound, and no chromosomal or genetic abnormalities; 4. Pregnant women had no severe underlying diseases, and no diseases interfering with fetal growth such as definite diabetes, chronic hypertension, autoimmune diseases, or moderate to severe thyroid dysfunction. 5. Subgroup Inclusion Criteria (1) Normal Pregnancy Control Group Inclusion: Meet the overall inclusion criteria; no complications such as FGR, preeclampsia, or preterm birth during pregnancy; fetal birth weight between the 10th and 90th percentile for the same gestational age (=P10 and =P90); newborn has no serious complications. (2) Early-Onset FGR Group Inclusion: Meet the overall inclusion criteria; clinical diagnosis of FGR at gestational age <32 weeks; complete delivery and follow-up data. (3) Late-Onset FGR Group Inclusion: Meet the overall inclusion criteria; clinical diagnosis of FGR at gestational age =32 weeks; complete delivery and follow-up data.

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancy and pregnancy conceived by assisted reproductive technology; 2. Fetuses complicated with structural malformations, chromosomal abnormalities or genetic syndromes; 3. Pregnant women complicated with diseases that may cause secondary FGR, including diabetes, hypertension, hepatic and renal insufficiency, autoimmune diseases, thyroid diseases, etc.; 4. Presence of interfering factors during pregnancy such as severe infection, drug/toxin exposure, alcohol abuse and smoking; 5. Cases with poor quality of ultrasound images, missing key indicators, loss to follow-up, or unclear pregnancy outcomes. 6. Subgroup Exclusion Criteria (1) Normal Pregnancy Control Group Exclusion: Occurrence of FGR, preeclampsia, preterm birth, birth weight P90; inaccurate gestational age assessment or missing birth weight data. (2) Early-Onset FGR Group Exclusion: FGR diagnosis at =32 weeks of gestation; missing key data. (3) Late-Onset FGR Group Exclusion: FGR diagnosis at <32 weeks of gestation; missing key data.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactRuizheng Han

The Third Affiliated Hospital of Zhengzhou University

hanruizheng37@126.com+86 371 6690 3479

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026