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
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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ACTIVE_NOT_RECRUITING
240 participants
OBSERVATIONAL
2024-01-31
2024-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
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
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
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
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
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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Can Ozan Ulusoy
Specialist Doctor- Maternal Fetal Medicine Unit
Locations
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Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye)
Countries
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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.
Other Identifiers
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AEŞH-BADEK-2024-43
Identifier Type: -
Identifier Source: org_study_id
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