Clinical trial NCT06712550: Assessment of Maternal and Fetal Serum Biomarkers in Women With Pre-eclampsia
Official title: Assessment of Maternal and Fetal Serum Soluble Fms-like Tyrosine Kinase-1, Seromucoid, and Protein-bound Hexose in Women With Pre-eclampsia: A Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Markers
Preeclampsia Severe
Preeclampsia Mild
Umbilical Cord Issue
Inflammatory Response
Serum Seromucoid in Pregnancy
Protein-bound Hexose in Preeclampsia
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This case-control study will include 200 pregnant women(100 with preeclampsia and 100 normotensive). Umbilical cord blood samples will be collected from both groups at the time of delivery. Serum samples will be analyzed for a panel of inflammatory markers.

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).

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

Primary outcomes:
measure: 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.
timeFrame: one hour
Secondary outcomes:
measure: To assess the association between the levels of these biomarkers and the severity of pre-eclampsia.
timeFrame: one hour
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University
state: Kurdistan Region
city: Erbil
country: Iraq
facility: Hawler Medical University
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University
name: SHAHLA K. ALALAF, prof.
role: STUDY_DIRECTOR
affiliation: Salahadin University, College of Science
name: Jiyan L. Hussein, Assis. prof
role: PRINCIPAL_INVESTIGATOR
References: