Pre-EclampsiaNCT05816044
Evaluation of HALP Score in Preeclampsia
An observational study of Pre-Eclampsia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Preeclampsia is a serious condition that can occur during pregnancy and can pose problems for both the mother and the baby. It occurs in approximately 2-8% of all pregnancies globally and is caused by issues with blood vessels, leading to elevated blood pressure and other related health concerns. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2023to 15 Jul 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
- Healthy volunteers accepted
- Adult
Study population: This study is a case-control retrospective study. Pregnant women between the ages of 18-44 who were diagnosed with preeclampsia and healthy pregnant woman in our clinic and whose follow-up and birth were in our hospital
Who may be able to join
- in preeclampsia group
- Having a singleton pregnancy.
- Pregnant women diagnosed with preeclampsia according to the American College of Obstetricians and Gynecologists (ACOG) 2020 gestational hypertension and preeclampsia bulletin criteria.
- Pregnant women who do not have a systemic inflammatory disease other than preeclampsia
- Pregnant women whose delivery and postpartum follow-up are in our clinic
- In the Control Group
Show all 10Show fewer
- Having a singleton pregnancy
- 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
- Pregnant women whose delivery and postpartum follow-up are in our clinic
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.)
- Unknown pregnancy follow-up or fetal or maternal abnormalities detected during follow-up pregnant women
- Pregnant women whose delivery or postpartum follow-up is outside of 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
Preeclampsia is a serious condition that can occur during pregnancy and can pose problems for both the mother and the baby. It occurs in approximately 2-8% of all pregnancies globally and is caused by issues with blood vessels, leading to elevated blood pressure and other related health concerns. Additionally, insufficient nutrition and inflammation within the mother's body may contribute to the development of preeclampsia.
The HALP score serves as a tool to assess various elements within the blood, indicating inflammation or inadequate nutrition. Although it has been utilized in other medical contexts, its application during pregnancy remains limited. The HALP score has been employed to predict the emergence of ailments such as heart disease and cancer. Given that preeclampsia can stem from inflammation and poor nutrition, the potential of the HALP score in predicting the likelihood of preeclampsia during pregnancy is being examined through research.
Read the detailed description
Preeclampsia is a hypertensive disorder affecting multiple body systems that poses a risk of maternal and fetal morbidity and mortality. The global prevalence of preeclampsia is estimated to be around 2-8% of all pregnancies. The pathophysiology of preeclampsia is complex and involves endothelial dysfunction and vasospasm, resulting in hypertension and end-organ damage. The development of preeclampsia is influenced by various factors, including abnormalities in the placenta, genetic factors, and maternal immune system. In addition, poor maternal nutrition and inflammation have also been identified as potential contributors to the development of preeclampsia.
The HALP score is a composite measure of hemoglobin, albumin, lymphocyte, and platelet parameters that has been suggested as a possible indicator of systemic inflammation and malnutrition. Although the HALP score has not been extensively studied in obstetrics, it has been investigated in various medical fields as a predictor of adverse outcomes such as cardiovascular disease and cancer. Given the significance of inflammation and malnutrition in the development of preeclampsia, it is important to investigate the potential usefulness of the HALP score in predicting this condition.
Due to the limited research on the application of the HALP score in obstetrics and the possible role of inflammation and malnutrition in the pathogenesis of preeclampsia, a retrospective study is being planned to explore the potential utility of the HALP score as a predictor of preeclampsia. By analyzing the relationship between the HALP score and the development of preeclampsia, valuable insights can be obtained regarding the potential involvement of inflammation and malnutrition in the development of this disorder.
- Conditions
- Pre-Eclampsia
- Keywords
- preeclampsia, HALP score
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preeclamptic pregnant woman | Not described | |
| healty preagnant woman | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the HALP score in preeclamptic and healty pregnant woman
The HALP score, which comprises Hemoglobin, Albumin, Lymphocyte, and Platelet parameters, is a useful tool for healthcare professionals to evaluate the nutritional and inflammatory status of a patient. Higher HALP scores are indicative of better immune-nutritional function, whereas lower scores suggest poorer immune-nutritional status. Thus, the HALP score provides valuable prognostic information that can guide treatment decisions and risk stratification for patients with various medical conditions. Currently, there is no standardized or universally accepted cutoff for the HALP score to predict specific outcomes. The optimal threshold for the HALP score is disease-specific and largely dependent on the study. This is based on the available literature.
Measured: From January 2021 to January 2023, examination findings and medical tests of pregnant women diagnosed with preeclampsia, as well as healthy pregnant women, will be retrospectively evaluated by utilizing data 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 posted18 Apr 2023
- Study start22 Feb 2023
- Primary completion22 May 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- 300 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816044
- Sponsor's protocol ID
- 67
- 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 HALP Score in Preeclampsia
- ClinicalTrials.gov ID
- NCT05816044
- Acronym / sponsor ID
- 67
- Conditions
- Pre-Eclampsia
- Keywords
- preeclampsia, HALP score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 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 Jul 2023 (actual)
- First posted
- 18 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.
Preeclampsia is a serious condition that can occur during pregnancy and can pose problems for both the mother and the baby. It occurs in approximately 2-8% of all pregnancies globally and is caused by issues with blood vessels, leading to elevated blood pressure and other related health concerns. Additionally, insufficient nutrition and inflammation within the mother's body may contribute to the development of preeclampsia.
The HALP score serves as a tool to assess various elements within the blood, indicating inflammation or inadequate nutrition. Although it has been utilized in other medical contexts, its application during pregnancy remains limited. The HALP score has been employed to predict the emergence of ailments such as heart disease and cancer. Given that preeclampsia can stem from inflammation and poor nutrition, the potential of the HALP score in predicting the likelihood of preeclampsia during pregnancy is being examined through research.
Detailed description
Preeclampsia is a hypertensive disorder affecting multiple body systems that poses a risk of maternal and fetal morbidity and mortality. The global prevalence of preeclampsia is estimated to be around 2-8% of all pregnancies. The pathophysiology of preeclampsia is complex and involves endothelial dysfunction and vasospasm, resulting in hypertension and end-organ damage. The development of preeclampsia is influenced by various factors, including abnormalities in the placenta, genetic factors, and maternal immune system. In addition, poor maternal nutrition and inflammation have also been identified as potential contributors to the development of preeclampsia.
The HALP score is a composite measure of hemoglobin, albumin, lymphocyte, and platelet parameters that has been suggested as a possible indicator of systemic inflammation and malnutrition. Although the HALP score has not been extensively studied in obstetrics, it has been investigated in various medical fields as a predictor of adverse outcomes such as cardiovascular disease and cancer. Given the significance of inflammation and malnutrition in the development of preeclampsia, it is important to investigate the potential usefulness of the HALP score in predicting this condition.
Due to the limited research on the application of the HALP score in obstetrics and the possible role of inflammation and malnutrition in the pathogenesis of preeclampsia, a retrospective study is being planned to explore the potential utility of the HALP score as a predictor of preeclampsia. By analyzing the relationship between the HALP score and the development of preeclampsia, valuable insights can be obtained regarding the potential involvement of inflammation and malnutrition in the development of this disorder.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclamptic pregnant woman | – | – |
| healty preagnant woman | – | – |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study is a case-control retrospective study. Pregnant women between the ages of 18-44 who were diagnosed with preeclampsia and healthy pregnant woman in our clinic and whose follow-up and birth were in our hospital
Key inclusion criteria (10 listed)
- in preeclampsia group
- In the Control Group
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.)
- Unknown pregnancy follow-up or fetal or maternal abnormalities detected during follow-up pregnant women
- Pregnant women whose delivery or postpartum follow-up is outside of 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.
Primary outcome
evaluate the HALP score in preeclamptic and healty pregnant woman
Time frame: From January 2021 to January 2023, examination findings and medical tests of pregnant women diagnosed with preeclampsia, as well as healthy pregnant women, will be retrospectively evaluated by utilizing data documented by scanning patient records.
The HALP score, which comprises Hemoglobin, Albumin, Lymphocyte, and Platelet parameters, is a useful tool for healthcare professionals to evaluate the nutritional and inflammatory status of a patient. Higher HALP scores are indicative of better immune-nutritional function, whereas lower scores suggest poorer immune-nutritional status. Thus, the HALP score provides valuable prognostic information that can guide treatment decisions and risk stratification for patients with various medical conditions. Currently, there is no standardized or universally accepted cutoff for the HALP score to predict specific outcomes. The optimal threshold for the HALP score is disease-specific and largely dependent on the study. This is based on the available literature.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pre-Eclampsia, 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 10 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 the HALP score in preeclamptic and healty pregnant woman (time frame: From January 2021 to January 2023, examination findings and medical tests of pregnant women diagnosed with preeclampsia, as well as healthy pregnant women, will be retrospectively evaluated by utilizing data 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.