- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07857525
HMGB1 Levels at Fetal Growth Restriction
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.
Studieoversikt
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Ortahisar
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Trabzon, Ortahisar, Tyrkia (Türkiye), 61080
- Karadeniz technical university, school of medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
all patients with ıugr pregnancy are study group. The other control group is normal pregnancies.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Serum HMGB1 Level
Tidsramme: From enrollment (20-41 weeks of gestation) until the collection and measurement of the serum HMGB1 sample.
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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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-224
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
No. Individual participant-level data will not be made available to other researchers.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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