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

NCT06712550 | Completed

• 1 other identifier: HawlerMU6
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  one hour

Secondary Outcomes (1)

• To assess the association between the levels of these biomarkers and the severity of pre-eclampsia.

  one hour

Study Arms (2)

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.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SHAHLA KAREEM ALALAF: lead

Study Sites (1)

Hawler Medical University

Erbil, Kurdistan Region, 44001, Iraq

Location

Study Officials

• SHAHLA K. ALALAF, prof.

  Hawler Medical University

  STUDY DIRECTOR

• Jiyan L. Hussein, Assis. prof

  Salahadin University, College of Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: December 13, 2024
• Primary Completion: July 3, 2025
• Study Completion: July 12, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

IR (1)