NCT04287998

Brief Summary

  1. 1.To measure the level of expression of MXRA5 and ANXA4 genes in preeclampsia (PE).
  2. 2.To detect the effect of heavy metals (lead (Pb) and arsenic (AR)) on these two genes in the pathology of PE.
  3. 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. 4.To detect Syndecan-1 by immunohistochemical antibodies.
  5. 5.To define the role of extracellular matrix remodelling in PE.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 22, 2020

Last Update Submit

February 26, 2020

Conditions

Keywords

MXRA5ANXA4Syndecan1TIMP1leadarsenic

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

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

• 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

Retention: SAMPLES WITH DNA

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

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Shimaa A Abd Elrahman, assistant lecturer

CONTACT

Mona A El Baz, Professor

CONTACT

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