Evaluation of HALP Score in Distinction Between FGR and SGA

August 28, 2023 updated by: murat ibrahim toplu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Evaluation of Hemoglobin, Albumin, Lymphocyte, Platelet (HALP) Score in Distinction Between Fetal Growth Restriction (FGR) and Small for Gestational Age (SGA)

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.

Study Overview

Detailed Description

Fetal Growth Restriction (FGR) and Small for Gestational Age (SGA) are two conditions that are commonly encountered in obstetrics. FGR is defined as a condition in which the fetus is smaller than expected for its gestational age, and its pathophysiology is thought to be influenced by both maternal inflammation and nutritional status. On the other hand, SGA is a condition in which the fetus is smaller than expected, but its pathophysiology is primarily attributed to constitutional and genetic factors.

It is important to distinguish between FGR and SGA because FGR is associated with a higher risk of adverse fetal and neonatal outcomes, including morbidity and mortality. In contrast, SGA infants are generally healthy, but may have a higher risk of long-term health problems, such as hypertension and diabetes.

The HALP score is a simple and easily calculated index that is based on the levels of hemoglobin, lymphocytes, albumin, and platelets. It has been shown to be informative about the nutritional and inflammatory status in various medical fields. However, its use in obstetrics is limited and its potential to distinguish between FGR and SGA has not been studied.

Given that maternal inflammation and nutritional status are also involved in the pathophysiology of FGR, it is possible that the HALP score could be useful in distinguishing between FGR and SGA. Therefore, we plan to investigate the potential of the HALP score in differentiating between these two conditions.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34384
        • Prof. Dr. Cemil Taşcıoğlu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FGR
In the group with FGR, we will calculate the HALP score with the complete blood count and albumin values.
we will calculate the HALP score with the complete blood count and albumin values in FGR and SGA groups.
SGA
In the group with SGA, we will calculate the HALP score with the complete blood count and albumin values.
we will calculate the HALP score with the complete blood count and albumin values in FGR and SGA groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) Score in Fetal Growth Restriction (FGR) and Small for Gestational Age (SGA) groups
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: murat i toplu, MD, Prof. Dr. Cemil Taşcıoğlu City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Actual)

May 22, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

April 1, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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