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Clinical research on noninvasive fetal lung maturity test based on artificial intelligence

Clinical research on noninvasive fetal lung maturity test based on artificial intelligence

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039853
Enrollment
Unknown
Registered
2020-11-12
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Neonatal respiratory diseases

Interventions

Gold Standard:Clinical outcome
Index test:quantusFLM

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: In this cohort study, the subjects include singleton pregnant women with gestational age between 28.0 and 39.0 weeks.This includes: 1) Pregnant women who plan to give birth within 48 hours or are likely to give birth are considered eligible, including: A. Patients planning selective induction of labor; B. Patients planning selective cesarean section; C. Patients with pregnancy complicationsincluding: a) Threatened preterm labor b) Premature rupture of membranes c) Various pregnancy complications, mainly preeclampsia and fetal growth restriction 2) Patients who received ultrasound scans of fetal lungs within 48 hours before delivery; 3) Signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Fetal structural or chromosomal abnormalities; 2) Corticosteroids were used between ultrasound and delivery to promote fetal lung maturity; 3) Excess body fat rate (BMI > 35kg/m2) within 1 week before delivery; 4) Neonatal sepsis, umbilical artery pH < 7.00, symptomatic anemia, and meconium aspiration; 5) Any condition that other researchers think is not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Neonatal respiratory distress syndrome;Transient Tachypnea of Newborn;SEN, SPE, ACC, AUC of ROC, PPV, NPV;

Countries

China

Contacts

Public ContactHui Feng

Peking University First Hospital

fenghuibt@163.com+86 15210820611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026