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Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach

Active, not recruiting
Conditions
Fetal Growth Restriction
Inflammatory Response
Interventions
Diagnostic Test: Ultrasound measurement
Diagnostic Test: Laboratory Tests and Inflammatory Markers
Registration Number
NCT06372938
Lead Sponsor
Ankara Etlik City Hospital
Brief Summary

Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges.

Detailed Description

Fetal growth restriction (FGR), also known as intrauterine growth restriction, is a prevalent pregnancy complication with potentially negative outcomes for newborns. The condition's causes are varied, involving genetic factors, maternal inflammation, infections, and other pathologies. FGR is categorized based on its onset: early-onset FGR occurs before 32 weeks' gestation, while late-onset happens after 32 weeks. Late-onset FGR, though less risky in perinatal complications compared to early-onset, is linked to an increased risk of hypoxemia and neurodevelopmental delays. Diagnosis primarily relies on ultrasound measurements and Doppler flow analysis of specific arteries. The study highlights the complexity of diagnosing and managing late-onset FGR, emphasizing the unclear pathophysiological mechanisms. It proposes the exploration of inflammatory processes and the potential role of new markers such as the systemic immune inflammation index (SII), systemic inflammatory response index (SIRI), and neutrophil-percentage-to-albumin ratio (NPAR) for understanding FGR. These markers are easily measured through blood tests and are significant in various diseases. The text also discusses the challenges of applying advanced diagnostic methods in low-income countries due to the need for sophisticated equipment, contrasting with the accessibility of artificial intelligence and machine learning models via the internet. The study aimed to assess the impact of inflammatory processes on late-onset FGR by analyzing NPAR, along with other markers, and evaluating their predictive value using machine learning algorithms.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
240
Inclusion Criteria
  • Between the ages of 18-45
  • Completed their pregnancy follow-up in our center
  • Pregnant women whose data can be accessed
  • Singleton pregnancies without systemic maternal comorbidities other than FGR
Exclusion Criteria
  • Multiple pregnancies
  • Having a maternal disease
  • Fetal congenital and chromosomal anomalies
  • Chronic drug use, alcohol and cigarette use
  • Accompanying additional pregnancy complications during follow-up
  • Cases whose data cannot be accessed

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Pregnant Women with Fetal Growth RestrictionUltrasound measurement120 patients will be included diagnosed with late-onset Fetal Growth Restriction.
Pregnant Women with Fetal Growth RestrictionLaboratory Tests and Inflammatory Markers120 patients will be included diagnosed with late-onset Fetal Growth Restriction.
Healthy PregnanciesLaboratory Tests and Inflammatory Markers120 patients will be included in a control group of developing fetuses according to gestational age.
Healthy PregnanciesUltrasound measurement120 patients will be included in a control group of developing fetuses according to gestational age.
Primary Outcome Measures
NameTimeMethod
Evaluation of dataWithin 1 month of data collection

To determine the statistical correlation of demographic data and inflammatory indices of pregnancy period with diagnostic ultrasonographic measurements (fetal biometric measurements and fetal doppler findings) related to fetal growth retardation in SPSS environment and to reveal the importance of the relationship.

Secondary Outcome Measures
NameTimeMethod
Machine learning modelingWithin 1 month of data after data analysis

The RandomForestClassifier class classification model will be developed by moving the data from the SPSS environment to the Python environment. Machine learning system modeling will be developed where the model will learn from the training set using patient data and use this information to predict future data.

Trial Locations

Locations (1)

Etlik City Hospital

🇹🇷

Ankara, Yenimahalle, Turkey

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