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NCT Number: NCT07349277

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Bint Al Huda Maternity Hospital

Nasiriyah, Dhi Qar, 64001, Iraq

Location status: Recruiting

Location contact

Ammar Jassim Abed

CONTACT

[email protected]

9647809561105

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum sFlt-1 concentration

    Time frame: At enrollment (20-36 weeks of gestation)

    Measurement of serum sFlt-1 levels in maternal serum using ELISA

  2. Serum PlGF concentration

    Time frame: At enrollment (20-36 weeks of gestation)

    Measurement of serum placental growth factor (PlGF) levels in maternal serum using ELISA.

  3. sFlt-1/PlGF ratio

    Time frame: At enrollment (20-36 weeks of gestation)

    Calculated ratio of serum sFlt-1 to serum PlGF concentrations

  4. Serum Osteoprotegerin (OPG) concentration

    Time frame: At enrollment (20-36 weeks of gestation)

    Measurement of serum osteoprotegerin (OPG) levels in maternal serum using ELISA.

  5. Serum sENG(Souble Endoglin) concentration

    Time frame: At enrollment (20-36 weeks of gestation)

    Measurement of serum soluble endoglin (sENG) levels in maternal serum using ELISA.

Study contacts

Contact information is provided by the study sponsor or research team.

Ammar Jassim Abed, MSc

CONTACT

[email protected]

+9647809561105

Sponsors and collaborators

Lead sponsor

Ammar Jassim Abed

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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