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

NCT ID: NCT07349277

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2026-04-30

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.

Conditions

Preeclampsia; Gestational Hypertension; Hypertensive Disorders of Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preeclampsia - No Antihypertensive Treatment

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).

No interventions assigned to this group

Preeclampsia - With Antihypertensive Treatment

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

No interventions assigned to this group

Healthy Pregnant Controls

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ammar Jassim Abed

OTHER

Sponsor Role: lead

Responsible Party

Ammar Jassim Abed

Master's Student (MSc Researcher), Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bint Al Huda Maternity Hospital

Nasiriyah, Dhi Qar, Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Ammar Jassim Abed, MSc

Role: CONTACT

ammar.jassim11@gmail.com

+9647809561105

Facility Contacts

Ammar Jassim Abed

Role: primary

ammar.jassim11@gmail.com

9647809561105

References

Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, Hall DR, Warren CE, Adoyi G, Ishaku S; International Society for the Study of Hypertension in Pregnancy (ISSHP). The hypertensive disorders of pregnancy: ISSHP classification, diagnosis & management recommendations for international practice. Pregnancy Hypertens. 2018 Jul;13:291-310. doi: 10.1016/j.preghy.2018.05.004. Epub 2018 May 24. No abstract available.

Reference Type: BACKGROUND

PMID: 29803330 (View on PubMed)

Miller JJ, Higgins V, Melamed N, Hladunewich M, Ma L, Yip PM, Fu L. Clinical Validation of the sFlt-1:PlGF Ratio as a Biomarker for Preeclampsia Diagnosis in a High-Risk Obstetrics Unit. J Appl Lab Med. 2023 May 4;8(3):457-468. doi: 10.1093/jalm/jfad003.

Reference Type: BACKGROUND

PMID: 36869760 (View on PubMed)

Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennstrom M, Olovsson M, Brennecke SP, Stepan H, Allegranza D, Dilba P, Schoedl M, Hund M, Verlohren S. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

Reference Type: BACKGROUND

PMID: 26735990 (View on PubMed)

Venkatesha S, Toporsian M, Lam C, Hanai J, Mammoto T, Kim YM, Bdolah Y, Lim KH, Yuan HT, Libermann TA, Stillman IE, Roberts D, D'Amore PA, Epstein FH, Sellke FW, Romero R, Sukhatme VP, Letarte M, Karumanchi SA. Soluble endoglin contributes to the pathogenesis of preeclampsia. Nat Med. 2006 Jun;12(6):642-9. doi: 10.1038/nm1429. Epub 2006 Jun 4.

Reference Type: BACKGROUND

PMID: 16751767 (View on PubMed)

Other Identifiers

35918

Identifier Type: -

Identifier Source: org_study_id