Evaluation of HALP Score in Distinction Between FGR and SGA

NCT05814198 | Completed

• 1 other identifier: 78
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Fetal Growth Restriction (FGR) and Small for Gestational Age (SGA) are two conditions that can happen when a baby doesn't grow as much as expected during pregnancy. FGR is caused by things like problems with the mother's nutrition and inflammation, while SGA is usually because of genetic and other factors. It's important to know if a baby has FGR or SGA because FGR babies can have more health problems and are at risk of dying before or shortly after birth. SGA babies are usually healthy, but they might have more health problems later in life. Doctors can use a simple blood test called the HALP score to see if a mother has problems with her nutrition and inflammation. However, it hasn't been studied for FGR and SGA. We want to study if the HALP score can help us tell if a baby has FGR or SGA by looking at the mother's blood test results.

Conditions

Fetal Growth Restriction; Small for Gestational Age at Delivery

Keywords

fetal growth restriction; small for gestational age

Outcome Measures

Primary Outcomes (1)

• Evaluate Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) Score in Fetal Growth Restriction (FGR) and Small for Gestational Age (SGA) groups

  The Hemoglobin, Albumin, Lymphocyte, Platelet (HALP) score represents a valuable tool for clinicians to assess a patient's nutritional and inflammatory status. Elevated HALP scores are indicative of superior immune-nutritional function, while lower scores are suggestive of poorer immune-nutritional status. As such, the HALP score offers important prognostic information that may inform treatment decisions and risk stratification for patients with various medical conditions. There is no standardized or universal threshold for the HALP score to stratify the risk of these outcomes. Based on the existing literature, the meaningful cutoff for HALP is disease-specific and largely study-specific.

  Data assessed from patient charts retrospectively/From January 2021 to January 2023, pregnant women who are diagnosed with FGR and SGA, will have their examination findings and medical tests documented by scanning patient records.

Study Arms (2)

FGR

In the group with FGR, we will calculate the HALP score with the complete blood count and albumin values.

Diagnostic Test: HALP score

SGA

In the group with SGA, we will calculate the HALP score with the complete blood count and albumin values.

Diagnostic Test: HALP score

Interventions

HALP score DIAGNOSTIC_TEST

we will calculate the HALP score with the complete blood count and albumin values in FGR and SGA groups.

FGR; SGA

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women between the ages of 18-44 who were diagnosed with FGR and SGA in our clinic and whose follow-up and birth were in our hospital

You may qualify if:

• Having a singleton pregnancy
• Pregnant women diagnosed with FGR and SGA in accordance with the criteria of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) diagnosis and management bulletin in SGA and FGR
• Pregnant women who do not have a systemic inflammatory disease other than FGR
• Pregnant women whose delivery and postpartum follow-up are in our clinic
• Pregnant women who have no history or signs of systemic disease
• Pregnant women who have not found any maternal or fetal abnormality in the pregnancy follow-up

You may not qualify if:

• Multiple gestation pregnancies
• Known chronic or systemic disease (hypo or hyperthyroidism, diabetes, chronic hypertension, heart diseases, hyperlipidemia, chronic liver failure, acute or chronic kidney failure, etc.)
• Pregnant women whose pregnancy follow-up is unknown or fetal or maternal abnormalities are detected in the follow-up
• Pregnant women whose delivery or postpartum follow-up is in a location other than our clinic

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

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 Officials

• murat i toplu, MD

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 14, 2023
• Study Start: February 22, 2023
• Primary Completion: May 22, 2023
• Study Completion: June 15, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

TU (1)