HMGB1 Levels at Fetal Growth Restriction
Diagnostic Value of Maternal Serum Hmgb1 Levels in the Diagnosis of Intrauterine Growth Restriction
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2025
1 active site
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
July 30, 2025
CompletedFirst Submitted
Initial submission to the registry
March 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
CompletedFirst Posted
Study publicly available on registry
October 5, 2026
CompletedOctober 5, 2026
September 1, 2026
11 months
March 26, 2026
September 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Serum HMGB1 Level
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.
Interventions
hmgb1 levels
Eligibility Criteria
all patients with ıugr pregnancy are study group. The other control group is normal pregnancies.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karadeniz technical university, school of medicine
Trabzon, Ortahisar, 61080, Turkey (Türkiye)
Biospecimen
plasma
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
March 26, 2026
First Posted
October 5, 2026
Study Start
July 30, 2025
Primary Completion
June 30, 2026
Study Completion
September 30, 2026
Last Updated
October 5, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
No. Individual participant-level data will not be made available to other researchers.