NCT05816044

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

April 1, 2023

Last Update Submit

August 28, 2023

Conditions

Keywords

preeclampsiaHALP score

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (2)

preeclamptic pregnant woman

healty preagnant woman

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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
  • 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

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.)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

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 18, 2023

Study Start

February 22, 2023

Primary Completion

May 22, 2023

Study Completion

July 15, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations