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

Ammar Jassim Abed

Status: Enrolling

Conditions: Preeclampsia; Gestational Hypertension; Hypertensive Disorders of Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT07349277

35918

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

120 participants in 3 patient groups

Preeclampsia - No Antihypertensive Treatment

Description:

This group includes pregnant women diagnosed with preeclampsia. Blood samples are collected at the time of diagnosis before starting any antihypertensive treatment. All participants will receive standard clinical care after sample collection. Samples will be processed, aliquoted, and stored at -80°C for biomarker analysis (sFlt-1, PlGF, soluble endoglin, and osteoprotegerin).

Preeclampsia - With Antihypertensive Treatment

Description:

is group includes pregnant women diagnosed with preeclampsia who are receiving standard antihypertensive therapy as part of their clinical care. Blood samples (5 mL) will be collected for measurement of biomarkers (sFlt-1, PlGF, sEng, OPG). Samples will be processed, aliquoted, and stored at -80°C. Clinical parameters and treatment details will also be recorded for analysi

Healthy Pregnant Controls

Description:

his group includes healthy pregnant women without preeclampsia. Blood samples (5 mL) will be collected to serve as controls for biomarker analysis. Samples will be processed, aliquoted, and stored at -80°C. Participants will receive routine prenatal care.