Bint Al Huda Maternity Hospital
Nasiriyah, Dhi Qar, 64001, Iraq
Location status: Recruiting
NCT Number: NCT07349277
his study investigates the effectiveness of three specific biological markers (biomarkers) in the blood-the sFlt-1/PlGF ratio, soluble endoglin (sEng), and osteoprotegerin (OPG)-to better diagnose and monitor preeclampsia. Preeclampsia is a serious pregnancy complication characterized by high blood pressure and potential organ damage that affects 2-8% of pregnancies worldwide
Interested in participating?
Request Info18 year–45 year
Female
Observational
Nasiriyah, Dhi Qar, 64001, Iraq
Location status: Recruiting
Preeclampsia is a pregnancy-specific hypertensive disorder characterized by newonset hypertension and proteinuria or other maternal organ dysfunction after 20 weeks of gestation. It affects 2-8% of pregnancies globally and remains a major contributor to maternal and perinatal morbidity and mortality The etiology is multifactorial, but placental dysfunction and abnormal angiogenesis are central to its pathogenesis. Given the limitations of current clinical indicators (e.g., blood pressure, proteinuria), there is growing interest in identifying predictive and diagnostic biomarkers to improve early detection, prognosis, and monitoring of therapeutic response. This study proposes to investigate three biomarkers: the sFlt-1/PlGF ratio, soluble endoglin (sEng), and osteoprotegerin (OPG), based on their roles in angiogenesis and endothelial dysfunction, which are hallmarks of preeclampsia
sFlt-1/PlGF Ratio Soluble fms-like tyrosine kinase-1 (sFlt-1) is an anti-angiogenic protein that binds to vascular endothelial growth factor (VEGF) and placental growth factor (PlGF), preventing their interaction with endothelial receptors. The imbalance, especially elevated sFlt-1 and decreased PlGF, is characteristic of preeclampsia. Numerous studies, including the multicenter PROGNOSIS trial, have validated the sFlt-1/PlGF ratio as a strong predictor of preeclampsia. A ratio ≥85 is associated with a high risk of developing preeclampsia within two weeks, while ≤38 effectively rules it out .
Soluble Endoglin (sEng) Endoglin is a co-receptor for transforming growth factor-beta (TGF-β), involved in vascular development. Its soluble form (sEng) acts as a decoy receptor, inhibiting TGF-β signaling, contributing to endothelial dysfunction, a key feature of preeclampsia. sEng levels are elevated in the maternal circulation prior to clinical onset and correlate with disease severity.
Osteoprotegerin (OPG) OPG, a member of the TNF receptor superfamily, is primarily involved in bone metabolism but also plays a role in vascular biology. Some studies have reported altered OPG levels in preeclampsia, potentially reflecting vascular damage or endothelial activation . Its role remains less defined, but it may complement other angiogenic markers in profiling disease status.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
IInclusion Criteria:
Exclusion criteria
Time frame: At enrollment (20-36 weeks of gestation)
Measurement of serum sFlt-1 levels in maternal serum using ELISA
Time frame: At enrollment (20-36 weeks of gestation)
Measurement of serum placental growth factor (PlGF) levels in maternal serum using ELISA.
Time frame: At enrollment (20-36 weeks of gestation)
Calculated ratio of serum sFlt-1 to serum PlGF concentrations
Time frame: At enrollment (20-36 weeks of gestation)
Measurement of serum osteoprotegerin (OPG) levels in maternal serum using ELISA.
Time frame: At enrollment (20-36 weeks of gestation)
Measurement of serum soluble endoglin (sENG) levels in maternal serum using ELISA.
Contact information is provided by the study sponsor or research team.
Ammar Jassim Abed
Other
Evaluation of sFlt-1/PlGF Ratio, Osteoprotegerin (OPG) and Soluble Endoglin (sEng) as Predictive Biomarkers in the Diagnosis and Treatment Evaluation of Preeclampsia
Acronym: PE-POSS
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