Amniotic Fluid Ischemia Modified Albumin as a Novel e Prenatal Diagnostic Marker for Down Syndrome

NCT04293380 | Completed

• 1 other identifier: suleymanG
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Down syndrome is the most common genetic disorder in the society that causes mental retardation. Today, screening tests (combined test, triple screening, ultrasonography and age) are performed for the diagnosis of down syndrome for all pregnant women. As a result of screening tests, amniocentesis is performed as a diagnostic test for the group at risk. Chromosome analysis from amniotic fluid requires a 3-week period for chromosome cultures to yield results. Several levels of biochemical markers, such as organic acids and pyridoxine metabolites, have been found to be elevated in the amniotic fluid. The investigators also plan to investigate ischemia-modified albumin, hepatocyte growth factor level in amniotic fluid.

Conditions

Down Syndrome; Prenatal Stress; Cytokines

Keywords

Down Syndrome; Prenatally; ischemic modified album; cytokines; amniyosyntesis

Outcome Measures

Primary Outcomes (1)

• The IMA levels

  The IMA levels in our study group was higher than control group.

  immediately after the procedure

Study Arms (2)

normal karyotype

OTHER

During the prenatal evaluation, IMA and cytokine values in amniotic fluid will be compared in cases with down syndrome and normal karyotype.

Procedure: amniosyntesis

down syndrome

OTHER

During the prenatal evaluation, IMA and cytokine values in amniotic fluid will be compared in cases with down syndrome and normal karyotype.

Procedure: amniosyntesis

Interventions

amniosyntesis PROCEDURE

down syndrome; normal karyotype

Eligibility Criteria

• Gender Eligibility Details: on pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• cases diagnosed with down syndrome in the Duzen laboratory chromosome culture
• cases which are normal in the Duzen laboratory chromosome culture

You may not qualify if:

• \- absent

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical Universty Medical School

Trabzon, 61100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• suleyman guven, professor

  karadeniz thecnical universty

  PRINCIPAL INVESTIGATOR

• erhan huseyın comert

  gole goverment hospital

  STUDY CHAIR

• emine seda guvendag guven

  karadeniz thecnical universty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: March 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)