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

NCT ID: NCT06372938

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-07-20

Brief Summary

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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

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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.

Conditions

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Fetal Growth Restriction Inflammatory Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pregnant Women with Fetal Growth Restriction

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

Ultrasound measurement

Intervention Type 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).

Laboratory Tests and Inflammatory Markers

Intervention Type 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

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

Ultrasound measurement

Intervention Type 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).

Laboratory Tests and Inflammatory Markers

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Can Ozan Ulusoy

Specialist Doctor- Maternal Fetal Medicine Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 39422068 (View on PubMed)

Other Identifiers

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AEŞH-BADEK-2024-43

Identifier Type: -

Identifier Source: org_study_id

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