NCT07857525

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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2026

Completed
Last Updated

October 5, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

March 26, 2026

Last Update Submit

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

hmgb1OTHER

hmgb1 levels

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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)

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Interventions

HMGB1 Protein

Intervention Hierarchy (Ancestors)

HMGB ProteinsDNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsHigh Mobility Group ProteinsChromosomal Proteins, Non-HistoneNuclear ProteinsNucleoproteins

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.

Locations