- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Ortahisar
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Trabzon, Ortahisar, Turkiet (Türkiye), 61080
- Karadeniz technical university, school of medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
all patients with ıugr pregnancy are study group. The other control group is normal pregnancies.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum HMGB1 Level
Tidsram: 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.
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-224
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
No. Individual participant-level data will not be made available to other researchers.
Läkemedels- och apparatinformation, studiedokument
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