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

NCT06372938 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

  • Fetal Growth Restriction
  • Inflammatory Response

Interventions

DIAGNOSTIC_TEST

Ultrasound measurement

The diagnosis of FGR was made according to the following Delphi criteria . EFW \<3rd percentile or EFW \<10th percentile with Doppler evidence of placental dysfunction (Umbilical artery Doppler (UA) pulsatility index (PI) \>95th percentile, absence of umbilical artery end-diastolic flow (UAEDF), or reverse-UAEDF and/or cerebroplacental ratio (CPR) \<5th percentile).

DIAGNOSTIC_TEST

Laboratory Tests and Inflammatory Markers

The laboratory values were measured at the time of FGR diagnosis (between 32 and 37 weeks of pregnancy). After evaluation of hemoglobin (g/dl), leukocytes (103/μL), monocytes (103/μL), lymphocytes (103/μL), neutrophils (103/μL), platelets (103/μL) and albumin (g/dl), the inflammation values were calculated as follows: ; * SII = Absolute platelet count (APC)\* Absolute neutrophil count (ANC) / Absolute lymphocyte count (ALC); * SIRI = Absolute monocyte count (AMC) \* ANC/ ALC; * NPAR = Proportion of neutrophils (in total leukocytes) (%) × 100/albumin (g/dL).

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-07-06
Completion
2024-07-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372938 on ClinicalTrials.gov