Fetal Growth RestrictionNCT05814198
Evaluation of HALP Score in Distinction Between FGR and SGA
An observational study of Fetal Growth Restriction and Small for Gestational Age at Delivery, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Fetal Growth Restriction, Small for Gestational Age at Delivery
- What is being tested?
- HALP score
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2023to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, 34384
About this study
Official title: 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.
Read the 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.
- Being tested
- HALP score
- Keywords
- fetal growth restriction, small for gestational age
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALP scoreDiagnostic test
we will calculate the HALP score with the complete blood count and albumin values in FGR and SGA groups.
| Study group | Role | What they receive |
|---|---|---|
| FGR | In the group with FGR, we will calculate the HALP score with the complete blood count and albumin values. Receives: Diagnostic Test: HALP score | |
| SGA | In the group with SGA, we will calculate the HALP score with the complete blood count and albumin values. Receives: Diagnostic Test: HALP score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start22 Feb 2023
- Primary completion22 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, murat ibrahim toplu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- murat i toplu, MD, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814198
- Sponsor's protocol ID
- 78
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemoglobin, Albumin, Lymphocyte, Platelet (HALP) Score in Distinction Between Fetal Growth Restriction (FGR) and Small for Gestational Age (SGA)
- ClinicalTrials.gov ID
- NCT05814198
- Acronym / sponsor ID
- 78
- Keywords
- fetal growth restriction, small for gestational age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGR | – | Diagnostic Test: HALP scoreIn the group with FGR, we will calculate the HALP score with the complete blood count and albumin values. |
| SGA | – | Diagnostic Test: HALP scoreIn the group with SGA, we will calculate the HALP score with the complete blood count and albumin values. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HALP scorewe will calculate the HALP score with the complete blood count and albumin values in FGR and SGA groups. | Diagnostic test | FGR, SGA |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
murat i toplu, MD principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction and Small for Gestational Age at Delivery, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.