IUGRNCT07857525
HMGB1 Levels at Fetal Growth Restriction
An observational study of IUGR, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUGR
- What is being tested?
- hmgb1
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2025to 30 Sep 2026
- How long will I take part?
- 30 Years
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: all patients with ıugr pregnancy are study group. The other control group is normal pregnancies.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz technical university, school of medicine
Trabzon, Ortahisar, 61080
About this study
Official title: 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.
Read more
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.
- Conditions
- IUGR
- Being tested
- hmgb1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hmgb1Other
hmgb1 levels
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment (20-41 weeks of gestation) until the collection and measurement of the serum HMGB1 sample.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Jul 2025
- Primary completion30 Jun 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUGRStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hidayet şal, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857525
- Sponsor's protocol ID
- 2025-224
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Individual participant-level data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Maternal Serum Hmgb1 Levels in the Diagnosis of Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT07857525
- Acronym / sponsor ID
- 2025-224
- Conditions
- IUGR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 5 Oct 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all patients with ıugr pregnancy are study group. The other control group is normal pregnancies.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hmgb1hmgb1 levels | Other | – |
Primary outcome
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.
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 5 Oct 2026.
- Individual participant dataSharing planned: No. No. Individual participant-level data will not be made available to other researchers.
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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 IUGR, run by Karadeniz Technical University 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 1 inclusion and 1 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 5 Oct 2026. 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?
Serum HMGB1 Level (time frame: From enrollment (20-41 weeks of gestation) until the collection and measurement of the serum HMGB1 sample.). 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 5 Oct 2026.