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

NCT06372938 | Active Not Recruiting

• 1 other identifier: AEŞH-BADEK-2024-43
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Growth Restriction; Inflammatory Response

Keywords

fetal growth restriction; inflammatory markers; machine learning algorithms

Outcome Measures

Primary Outcomes (1)

• Evaluation of data

  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.

  Within 1 month of data collection

Secondary Outcomes (1)

• Machine learning modeling

  Within 1 month of data after data analysis

Study Arms (2)

Pregnant Women with Fetal Growth Restriction

120 patients will be included diagnosed with late-onset Fetal Growth Restriction.

Diagnostic Test: Ultrasound measurement; Diagnostic Test: Laboratory Tests and Inflammatory Markers

Healthy Pregnancies

120 patients will be included in a control group of developing fetuses according to gestational age.

Diagnostic Test: Ultrasound measurement; Diagnostic Test: Laboratory Tests and Inflammatory Markers

Interventions

Ultrasound measurement DIAGNOSTIC_TEST

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).

Healthy Pregnancies; Pregnant Women with Fetal Growth Restriction

Laboratory Tests and Inflammatory Markers DIAGNOSTIC_TEST

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).

Healthy Pregnancies; Pregnant Women with Fetal Growth Restriction

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The sample of the study consists of pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will include 240 patients between 32-37 weeks of gestational age who were admitted to the Perinatology Clinic, Ministry of Health, Etlik City Hospital, Ankara/Turkey between 2023 and 2024. Head-hip length in the first trimester was used to confirm gestational age. Of the patients included in the study, 120 patients diagnosed with late-onset FGR and 120 patients with developing fetuses according to gestational age will be included in the control group.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (1)

• Ulusoy CO, Kurt A, Seyhanli Z, Hizli B, Bucak M, Agaoglu RT, Oguz Y, Yucel KY. Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine-Learning Approach. Am J Reprod Immunol. 2024 Oct;92(4):e70004. doi: 10.1111/aji.70004.

  PMID: 39422068 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor- Maternal Fetal Medicine Unit

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 18, 2024
• Study Start: January 31, 2024
• Primary Completion: July 6, 2024
• Study Completion: July 20, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)