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

NCT ID: NCT06712550

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 204 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2025-07-12

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).

Conditions

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

Study Design

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

Study Groups

Women with Preeclampsia

This group will comprise pregnant women having preeclampsia who are scheduled to undergo either vaginal or cesarean delivery. Their blood and their newborn blood will be collected and tested for a panel of inflammatory markers. This research aims to explore the potential association between maternal and neonatal inflammatory profiles and the development of preeclampsia, as well as its impact on pregnancy outcomes. By examining these markers, we hope to gain a better understanding of the underlying inflammatory mechanisms involved in preeclampsia.

No interventions assigned to this group

Normotensive pregnant women

This group will consist of normotensive pregnant women during delivery who are scheduled to have their blood and their newborn blood tested for a panel of inflammatory markers and responses to inflammatory markers. One of the aims of this research is to investigate the potential association between maternal and neonatal inflammatory profiles in normotensive pregnancy in comparison to women with preeclampsia and their newborn By examining these markers

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SHAHLA KAREEM ALALAF

OTHER

Sponsor Role: lead

Responsible Party

SHAHLA KAREEM ALALAF

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SHAHLA K. ALALAF, prof.

Role: STUDY_DIRECTOR

Hawler Medical University

Jiyan L. Hussein, Assis. prof

Role: PRINCIPAL_INVESTIGATOR

Salahadin University, College of Science

Locations

Hawler Medical University

Erbil, Kurdistan Region, Iraq

Countries

Iraq

Other Identifiers

HawlerMU6

Identifier Type: -

Identifier Source: org_study_id