Role and Expression of MXRA5 in Placental Connective Tissue Remodelling in Preeclampsia
Role and Expression of Matrix-remodelling Associated 5 Protein (MXRA5) in Connective Tissue Remodelling of Placenta in Preeclampsia
1 other identifier
observational
50
0 countries
N/A
Brief Summary
- 1.To measure the level of expression of MXRA5 and ANXA4 genes in preeclampsia (PE).
- 2.To detect the effect of heavy metals (lead (Pb) and arsenic (AR)) on these two genes in the pathology of PE.
- 3.To explore the association of the previous two genes with the heavy metals in link with Phosphoinositide 3-kinases/Protein Kinase B (PI3K/AKT) pathway.
- 4.To detect Syndecan-1 by immunohistochemical antibodies.
- 5.To define the role of extracellular matrix remodelling in PE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFebruary 27, 2020
February 1, 2020
1 year
February 22, 2020
February 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gene expression level of MXRA5 gene in PE patients and control group
1 year
Secondary Outcomes (4)
Gene expression level of ANXA4 in PE patients and control group.
1 year
Gene expression level of TIMP1 gene in PE patients and control group.
1 year
Protein level measurement of phosphorylated AKT(pAKT) in PE patients and control group.
1 year
Measurement of lead and arsenic level in PE patients and control group.
1 year
Study Arms (2)
1
PE group
2
Control group
Eligibility Criteria
• Placental tissue samples (surgically obtained during the caesarean section from 50 pregnant women) will be selected: * 25 PE patients undergoing caesarean section following diagnosis by blood pressure measurement and urine analysis. * 25 controls undergoing caesarean section. * Placental samples are 4x6 cm in dimension. Blood samples: Six milliliters of maternal blood was collected in plastic tubes. Urinary samples.
You may qualify if:
- Gestational age is \>28 weeks.
- Clinically diagnosed PE with blood pressure (≥140/90 mmHg) and proteinuria (≥300mg/dl).
- Healthy pregnant women (age matched control group).
You may not qualify if:
- Gestational diabetes.
- Pregestational hypertension (essential hypertension) or proteinuria.
- Systemic illness.
- Vaginal infection.
- Major known fetal or chromosomal anomalies.
- Multiple gestations.
- Intrauterine infections.
- Preterm premature rupture of membranes.
- Sepsis.
- Fever.
- Colitis ulcerosa.
- Crohn's disease.
- Chronic renal disease.
- Rheumatic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Placental Tissue samples collection: • Placental tissue samples (surgically obtained during the caesarean section from 50 pregnant women) will be selected: * 25 PE patients undergoing the caesarean section following confirmation of diagnosis clinically by blood pressure measurement and by urine analysis to detect the proteinuria. * 25 control women undergoing the caesarean section. Blood samples. Urinary samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2020
First Posted
February 27, 2020
Study Start
April 1, 2020
Primary Completion
April 1, 2021
Study Completion
May 1, 2021
Last Updated
February 27, 2020
Record last verified: 2020-02