Down SyndromeNCT04293380
Amniotic Fluid Ischemia Modified Albumin as a Novel e Prenatal Diagnostic Marker for Down Syndrome
A study testing amniosyntesis in people with Down Syndrome and Prenatal Stress, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Prenatal Stress, Cytokines
- What is being tested?
- amniosyntesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2012to 1 Sep 2016
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 20 cases diagnosed with down syndrome in the Duzen laboratory chromosome culture
- 74 cases which are normal in the Duzen laboratory chromosome culture
Who cannot join
- absent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical Universty Medical School
Trabzon, 61100
About this study
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.
Read the detailed description
The alpha feto protein level showing liver function is lower in babies with Down syndrome and this biochemical marker is one of the basic parameters of triple screening.
If these babies have insufficient liver function, then it is likely that there is a decrease in hepatocyte growth factor in these babies. Free E3 is higher in Down syndrome than normal pregnant women. Placental hyperfunction, fetal hypofunction (especially based on fetal liver) is accepted as the hypothetical cause of these two conditions in Down syndrome. In this study, the investigators think that the real cause of this condition is secondary to fetal partial hypoxia. For this purpose, the investigators plan to look at the level of IMA in amniotic fluid. However, Güven et al. In his study, an increased rate of ischemia-modified albumin was found in the amnion levels of mothers who had high triple screening tests but had no down syndrome in their babies. In this study, it is aimed to find a change in amniotic fluid that can help in the diagnosis of down syndrome. In our opinion, in cases of down syndrome, there will be an increase in IMA in the amniotic fluid secondary to ischemia, which is more severe than the false triple test positivity.
In our university, chromosome analyzes are made from amnion fluids sent to the Duzen laboratory. This laboratory hides amniotic fluid of patients with down syndrome (in the context of an agreement between our university and the laboratory). Within the scope of the research, amniotic fluids of 20 cases diagnosed with down syndrome in the Department of Obstetrics and Gynecology of KTU Faculty of Medicine will be obtained from the regulation laboratory and necessary biochemical evaluations will be performed. As the control group, amniotic fluids will be provided by 60 patients with normal amniocentesis results. The demographic factor, obstetric history and gynecological history information of all cases will be recorded in the questionnaire prepared by one of the researchers. 2 cc amnion sample of the patients with Down syndrome diagnosis and control group will be taken into the biochemistry tube and serum IMA and HGF values will be measured in KTU Faculty of Medicine, Department of Biochemistry. As a result, amnion IMA, HGF values of 20 cases diagnosed with down syndrome and amnion IMA, HGF values of 60 cases with down syndrome will be entered into SPSS 10.5 for Windows environment and their mean values will be compared.
According to the results, amniotic fluid IMA values of the study group and control group will be compared. Thus, it is aimed to eliminate the burden that the chromosome culture will bring to the national economy with an evaluation made in a routine laboratory in cases diagnosed with down syndrome.
- Conditions
- Down Syndrome, Prenatal Stress, Cytokines
- Being tested
- amniosyntesis
- Keywords
- Down Syndrome, Prenatally, ischemic modified album, cytokines, amniyosyntesis
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniosyntesisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: amniosyntesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The IMA levels
The IMA levels in our study group was higher than control group.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Mar 2012
- Primary completion1 Jun 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
- Investigators
- suleyman guven, professor, Principal investigator, karadeniz thecnical universtyerhan huseyın comert, Study chair, gole goverment hospitalemine seda guvendag guven, Study chair, karadeniz thecnical universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293380
- Sponsor's protocol ID
- suleymanG
- Status last verified
- Dec 2020
- First submitted
- 27 Feb 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Fluid Ischemia Modified Albumin as a Novel e Prenatal Diagnostic Marker for Down Syndrome
- ClinicalTrials.gov ID
- NCT04293380
- Acronym / sponsor ID
- suleymanG
- Conditions
- Down Syndrome, Prenatal Stress, Cytokines
- Keywords
- Down Syndrome, Prenatally, ischemic modified album, cytokines, amniyosyntesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 3 Mar 2020 (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.
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.
Detailed description
The alpha feto protein level showing liver function is lower in babies with Down syndrome and this biochemical marker is one of the basic parameters of triple screening.
If these babies have insufficient liver function, then it is likely that there is a decrease in hepatocyte growth factor in these babies. Free E3 is higher in Down syndrome than normal pregnant women. Placental hyperfunction, fetal hypofunction (especially based on fetal liver) is accepted as the hypothetical cause of these two conditions in Down syndrome. In this study, the investigators think that the real cause of this condition is secondary to fetal partial hypoxia. For this purpose, the investigators plan to look at the level of IMA in amniotic fluid. However, Güven et al. In his study, an increased rate of ischemia-modified albumin was found in the amnion levels of mothers who had high triple screening tests but had no down syndrome in their babies. In this study, it is aimed to find a change in amniotic fluid that can help in the diagnosis of down syndrome. In our opinion, in cases of down syndrome, there will be an increase in IMA in the amniotic fluid secondary to ischemia, which is more severe than the false triple test positivity.
In our university, chromosome analyzes are made from amnion fluids sent to the Duzen laboratory. This laboratory hides amniotic fluid of patients with down syndrome (in the context of an agreement between our university and the laboratory). Within the scope of the research, amniotic fluids of 20 cases diagnosed with down syndrome in the Department of Obstetrics and Gynecology of KTU Faculty of Medicine will be obtained from the regulation laboratory and necessary biochemical evaluations will be performed. As the control group, amniotic fluids will be provided by 60 patients with normal amniocentesis results. The demographic factor, obstetric history and gynecological history information of all cases will be recorded in the questionnaire prepared by one of the researchers. 2 cc amnion sample of the patients with Down syndrome diagnosis and control group will be taken into the biochemistry tube and serum IMA and HGF values will be measured in KTU Faculty of Medicine, Department of Biochemistry. As a result, amnion IMA, HGF values of 20 cases diagnosed with down syndrome and amnion IMA, HGF values of 60 cases with down syndrome will be entered into SPSS 10.5 for Windows environment and their mean values will be compared.
According to the results, amniotic fluid IMA values of the study group and control group will be compared. Thus, it is aimed to eliminate the burden that the chromosome culture will bring to the national economy with an evaluation made in a routine laboratory in cases diagnosed with down syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal karyotype | Other | Procedure: amniosyntesisDuring the prenatal evaluation, IMA and cytokine values in amniotic fluid will be compared in cases with down syndrome and normal karyotype. |
| down syndrome | Other | Procedure: amniosyntesisDuring the prenatal evaluation, IMA and cytokine values in amniotic fluid will be compared in cases with down syndrome and normal karyotype. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 20 cases diagnosed with down syndrome in the Duzen laboratory chromosome culture
- 74 cases which are normal in the Duzen laboratory chromosome culture
Key exclusion criteria (1 listed)
- absent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amniosyntesis | Procedure or surgery | down syndrome, normal karyotype |
Primary outcome
The IMA levels
Time frame: immediately after the procedure
The IMA levels in our study group was higher than control group.
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 17 Dec 2020.
- Individual participant dataSharing planned: No
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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.
suleyman guven, professor principal investigator
karadeniz thecnical universty
erhan huseyın comert study chair
gole goverment hospital
emine seda guvendag guven study chair
karadeniz thecnical universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amniosyntesis in people with Down Syndrome and Prenatal Stress, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 17 Dec 2020. 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 Turkey (Türkiye). 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?
The IMA levels (time frame: immediately after the procedure). 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 17 Dec 2020.