HMGB1 Levels at Fetal Growth Restriction

September 30, 2026 updated by: hidayet şal, Karadeniz Technical University

Diagnostic Value of Maternal Serum Hmgb1 Levels in the Diagnosis of Intrauterine Growth Restriction

The primary aim of this study is to evaluate HMGB1 levels in cases of intrauterine growth restriction (IUGR).

The secondary aim is to determine whether the cerebroplacental ratio interacts with these levels.

IUGR occurs when the fetus fails to reach its expected uterine growth potential due to fetal, maternal, and/or placental factors. IUGR occurs in approximately 10% of pregnancies worldwide. IUGR is associated with high perinatal morbidity and mortality rates.

High motility group box 1 (HMGB1) is the most abundant member of the high motility group (HMG) protein family and is expressed in almost all human cells. HMGB1 is predominantly found in the nucleus and can also shuttle actively and passively between the nucleus and cytoplasm. During cell apoptosis and necrosis, HMGB1 is released from dying cells into the extracellular space.

In high-risk pregnancies, particularly preeclampsia, HMGB1 levels are known to be elevated in the maternal circulation. A study investigating the possible link between sterile inflammation mediated by HMGB1 and the angiogenic imbalance observed in preeclampsia showed that high HMGB1 expression and its release from hypoxic trophoblasts play a critical role and contribute to angiogenic imbalance in preeclampsia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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

  • Turkey (Türkiye)
    • Ortahisar
      • Trabzon, Ortahisar, Turkey (Türkiye), 61080
        • Karadeniz technical university, school of medicine

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

all patients with ıugr pregnancy are study group. The other control group is normal pregnancies.

Description

Inclusion Criteria:

Pregnant women aged 18-45 years. Gestational age between 20 and 41 weeks. Pregnant women with IUGR or without IUGR. Willingness to participate in the study and provide written informed consent.

Exclusion Criteria:

Small-for-gestational-age (SGA) pregnancy. Multiple pregnancy. History of inflammatory, autoimmune, or rheumatic disease. Inability to provide adequate study data or refusal to provide a blood sample.

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum HMGB1 Level
Time Frame: From enrollment (20-41 weeks of gestation) until the collection and measurement of the serum HMGB1 sample.

Comparison of serum HMGB1 levels between pregnant women with intrauterine growth restriction (IUGR) and those without IUGR. Serum HMGB1 levels will be measured in venous blood samples using the ELISA method and compared between the two groups.
From enrollment (20-41 weeks of gestation) until the collection and measurement of the serum HMGB1 sample.

Collaborators and Investigators

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

Sponsor

Karadeniz Technical University

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)

July 30, 2025

Primary Completion (Actual)

June 30, 2026

Study Completion (Actual)

September 30, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

September 30, 2026

First Posted (Actual)

October 5, 2026

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

September 30, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No. Individual participant-level data will not be made available to other researchers.

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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