Inflammatory MarkersNCT06712550
Assessment of Maternal and Fetal Serum Biomarkers in Women With Pre-eclampsia
An observational study of Inflammatory Markers and Preeclampsia Severe, run by SHAHLA KAREEM ALALAF at 1 site in Iraq.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Inflammatory Markers, Preeclampsia Severe, Preeclampsia Mild
- How many people
- 204 participants
- Where
- 1 siteIraq
- Study dates
- 13 Dec 2024to 12 Jul 2025
- How long will I take part?
- 13 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one hour
Secondary outcomes (1)
To assess the association between the levels of these biomarkers and the severity of pre-eclampsia.
- 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.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start13 Dec 2024
- Primary completion3 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory MarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
- Target duration
- 13 Months
Sponsor and investigators
- Lead sponsor
- SHAHLA KAREEM ALALAF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SHAHLA KAREEM ALALAF, Hawler Medical University
- Investigators
- SHAHLA K. ALALAF, prof., Study director, Hawler Medical UniversityJiyan L. Hussein, Assis. prof, Principal investigator, Salahadin University, College of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712550
- Sponsor's protocol ID
- HawlerMU6
- Status last verified
- Jul 2025
- First submitted
- 26 Nov 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06712550
- Acronym / sponsor ID
- HawlerMU6
- Conditions
- Inflammatory Markers, Preeclampsia Severe, Preeclampsia Mild, Umbilical Cord Issue, Inflammatory Response, Serum Seromucoid in Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- SHAHLA KAREEM ALALAFUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 13 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
1 secondary outcome
To assess the association between the levels of these biomarkers and the severity of pre-eclampsia.
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHAHLA K. ALALAF, prof. study director
Hawler Medical University
Jiyan L. Hussein, Assis. prof principal investigator
Salahadin University, College of Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Markers and Preeclampsia Severe, run by SHAHLA KAREEM ALALAF at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.