Assessment of Maternal and Fetal Serum Biomarkers in Women With Pre-eclampsia

Recruiting

• Conditions: Inflammatory Markers; Preeclampsia Severe; Preeclampsia Mild; Umbilical Cord Issue; Inflammatory Response; Serum Seromucoid in Pregnancy; Protein-bound Hexose in Preeclampsia

• Registration Number: NCT06712550
• Lead Sponsor: SHAHLA KAREEM ALALAF

Brief Summary

The findings of markers of placental dysfunction in women with preeclampsia may suggest that these biomarkers may be useful tools for early detection of preeclampsia

Detailed Description

Preeclampsia is a pregnancy-specific hypertension illness that is characterized by widespread maternal endothelial dysfunction and appears to be a systemic syndrome that originates in the placenta. Through binding to and blocking the interaction of placental growth factor (PlGF) and vascular endothelial growth factor (VEGF) with their receptors Flt1, soluble fms-like tyrosine kinase (sFlt1) functions as an antagonist of these growth factors. Most seromucoid and protein-bound hexose are released during an acute phase and are inflammatory glycoproteins. Hepatocytes in the liver, which are highly sensitive to stress, increase and leak into the bloodstream during any disease state. It is a time when the placenta demands more vascular development. In order to identify and explain the differences in sFLT-1, VEGF, PlGF levels, and inflammatory biomarker responses. Current study will investigate the differences in blood level of sFLT-1, VEGF, PLGF, Seromucoid and protein-bound hexose inflammatory biomarkers between those with PE (cases) and healthy pregnant women (controls).

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Status Verified: 2024-12
• Study First Posted: 2024-12-02
• Study Start: 2024-12-13
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-09-03
• Study Completion: 2026-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Age group 18-45 years
• Gestational age of 26-41 weeks at the time of diagnosis for preeclampsia
• Delivered vaginally or abdominally
• Being of any parity (para 1 and more)
• Pregnancy being singleton or multiple pregnancies
• Willingness to provide informed consent

Exclusion Criteria

• Pregnant woman having chronic hypertension
• Having Diabetes mellitus
• The lady on medications that can affect inflammatory markers or blood pressure
• Pregnant with fetal anomalies
• Refused to involve in the research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the levels of maternal and fetal serum soluble Fms-like tyrosine kinase-1 (sFlt-1), seromucoid, and protein-bound hexose between women with pre-eclampsia and a control group of healthy pregnant women.	one hour	To quantify and compare the concentrations of soluble Fms-like tyrosine kinase-1 (sFlt-1), seromucoid, and protein-bound hexose in maternal and fetal serum between women diagnosed with pre-eclampsia and a control group of normotensive pregnant women.

Secondary Outcome Measures

Name	Time	Method
To assess the association between the levels of these biomarkers and the severity of pre-eclampsia.	one hour	o quantify and compare the concentrations of soluble Fms-like tyrosine kinase-1 (sFlt-1), seromucoid, and protein-bound hexose in maternal and fetal serum between women diagnosed with pre-eclampsia and a control group of normotensive pregnant women.

Trial Locations

Locations (1)

Hawler Medical University; 🇮🇶 Erbil, Kurdistan Region, Iraq