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Evaluation of sFlt-1/PlGF Ratio ,OPG and sEng as Predictive Biomarkers in the Diagnosis and Treatment Evaluation of Preeclampsia

Evaluation of sFlt-1/PlGF Ratio, Osteoprotegerin (OPG) and Soluble Endoglin (sEng) as Predictive Biomarkers in the Diagnosis and Treatment Evaluation of Preeclampsia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07349277
Acronym
PE-POSS
Enrollment
120
Registered
2026-01-16
Start date
2025-10-10
Completion date
2026-04-30
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Hypertension, Hypertensive Disorders of Pregnancy, Preeclampsia

Keywords

sFlt-1/PlGF ratio, Soluble Endoglin (sEng), Osteoprotegerin (OPG), Angiogenesis, Placental Dysfunction, Preeclampsia, methyldopa

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

Ammar Jassim Abed
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

IInclusion Criteria: * Pregnant women between 20 and 36 weeks of gestation * Age between 18 and 45 years * Attending the antenatal clinic at the study site

Exclusion criteria

* Chronic hypertension * Renal disease * Diabetes mellitus * Multiple gestations * Autoimmune disorders

Design outcomes

Primary

MeasureTime frameDescription
Serum sFlt-1 concentrationAt enrollment (20-36 weeks of gestation)Measurement of serum sFlt-1 levels in maternal serum using ELISA
Serum PlGF concentrationAt enrollment (20-36 weeks of gestation)Measurement of serum placental growth factor (PlGF) levels in maternal serum using ELISA.
sFlt-1/PlGF ratioAt enrollment (20-36 weeks of gestation)Calculated ratio of serum sFlt-1 to serum PlGF concentrations
Serum Osteoprotegerin (OPG) concentrationAt enrollment (20-36 weeks of gestation)Measurement of serum osteoprotegerin (OPG) levels in maternal serum using ELISA.
Serum sENG(Souble Endoglin) concentrationAt enrollment (20-36 weeks of gestation)Measurement of serum soluble endoglin (sENG) levels in maternal serum using ELISA.

Countries

Iraq

Contacts

CONTACTAmmar Jassim Abed, MSc
ammar.jassim11@gmail.com+9647809561105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026