Neural Tube DefectsNTD&HMsNCT04523233
Metals/Vitamins Levels in NTD
An observational study of Neural Tube Defects, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Heavy metals important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. The aims of this study were to determine the levels of trace elements and heavy metals, namely folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Neural Tube Defects
- What is being tested?
- Amniocentesis
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2020to 28 Feb 2022
- 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 40 years
- Women only
- Adult
Study population: The study group included 70 pregnant women with congenital NTDs (e.g. anencephaly, spina bifida, acrania, NTDs, and encephalocele) with a normal karyotype, which were detected in detailed ultrasonographic examinations, and 70 healthy pregnancies will be selected for the control group.
Who may be able to join
- Pregnant women complicated with Neural tube defects
- Healthy pregnancy
- Singleton pregnancy
Who cannot join
- pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
- women who have dyed their hair in the last 5 months
- history of using any medication
- presence of gestational hypertension or gestational diabetes
- drug user
- patients who had other fetal congenital abnormalities or genetic syndromes
Show all 9Show fewer
- multiple-gestation pregnancies
- intrauterine fetal death
- oligohydramnios
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cengiz Gokcek Women's and Child's hospital
Gaziantep, 27010
Ali Ovayolu, MD, 00905326404060, drovayolu@yahoo.com
About this study
Official title: Maternal Plasma/Urine/Hair/Amniotic Fluid Levels of Selected Trace Elements and Heavy Metals in Pregnancies Complicated With Neural Tube Defects
Introduction: Heavy metals important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. The aims of this study were to determine the levels of trace elements and heavy metals, namely folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se), in the amniotic fluid of pregnant women, and to investigate their relationship with neural tube defects (NTDs).
Methods: The study will be included 70 pregnant women whose fetuses were complicated with NTDs (study group) and 70 pregnant women with unaffected healthy fetuses (control group). The samples levels of elements and vitamins will be measured using inductively coupled plasma-mass spectrometry and will be compared between the two groups.
Read the detailed description
Detailed Description:
This observational case-control study will be conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between August 2020 and March 2021. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2020/167). The study strictly will be adhered to the principles of the Declaration of Helsinki. All women will be provided written informed consent before the acquisition of all samples. The study will be included 140 pregnant women who underwent amniocentesis at the investigator's perinatology department.
The study group will be included 70 pregnant women whose fetuses were found to have congenital NTDs (eg, anencephaly, spina bifida, acrania, and encephalocele) on detailed ultrasonographic examinations between 16 and 37 weeks of pregnancy. The control group included pregnant women with healthy fetuses (n = 70), who were matched for gestational weeks and maternal age and underwent amniocentesis because of age-related risk or increased risk in the triple test. Then, this study will be determined maternal plasma/urine/hair, and amniotic fluid folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se) concentrations in women with NTD compared to those of volunteer healthy pregnant women.
- Conditions
- Neural Tube Defects
- Being tested
- Amniocentesis
- Medical subject headings
- Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmniocentesisDiagnostic test
Also called elements/vitamins concentrations measurements
Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment.
| Study group | Role | What they receive |
|---|---|---|
| Neural tube defects (NTDs) | NTDs are a group of birth defects in which an opening in the spine or cranium remains from early in human development. Neural tube defects may be diagnosed during the ultrasound scan that is carried out around week 12 of the pregnancy or, more likely, during the anomaly scan that is carried out at around weeks 19 to 20. Receives: Diagnostic Test: Amniocentesis | |
| Control group | The control group will be included pregnant women with healthy fetuses (n = 70), who were matched for gestational weeks and maternal age and underwent amniocentesis because of age-related risk or increased risk in the triple test. Receives: Diagnostic Test: Amniocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
elements/vitamins concentrations in both group
The primary outcome in these analyses will compare folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminum (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se) concentrations in NTD group and control group.
Measured: 1 week
Secondary outcomes (1)
compore in NTDs group
The secondary outcome in these analyses will compare the elements and vitamins concentrations in the spinal NTD group and the cranial NTD group.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start25 Aug 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neural Tube DefectsStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cengiz Gokcek Women's and Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bozok University
- Responsible party
- Principal investigator, Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523233
- Sponsor's protocol ID
- CengizGWCH8
- Acronym
- NTD&HMs
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ovayolu A, Ovayolu G, Karaman E, Yuce T, Ozek MA, Turksoy VA. Amniotic fluid levels of selected trace elements and heavy metals in pregnancies complicated with neural tube defects. Congenit Anom (Kyoto). 2020 Sep;60(5):136-141. doi: 10.1111/cga.12363. Epub 2019 Nov 27.
PubMed 31743503Wilson RD; SOGC GENETICS COMMITTEE; SPECIAL CONTRIBUTOR. RETIRED: Prenatal screening, diagnosis, and pregnancy management of fetal neural tube defects. J Obstet Gynaecol Can. 2014 Oct;36(10):927-939. doi: 10.1016/S1701-2163(15)30444-8.
PubMed 25375307Yan L, Wang B, Li Z, Liu Y, Huo W, Wang J, Li Z, Ren A. Association of essential trace metals in maternal hair with the risk of neural tube defects in offspring. Birth Defects Res. 2017 Feb 15;109(3):234-243. doi: 10.1002/bdra.23594.
PubMed 27918138Nikolopoulou E, Galea GL, Rolo A, Greene ND, Copp AJ. Neural tube closure: cellular, molecular and biomechanical mechanisms. Development. 2017 Feb 15;144(4):552-566. doi: 10.1242/dev.145904.
PubMed 28196803
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Plasma/Urine/Hair/Amniotic Fluid Levels of Selected Trace Elements and Heavy Metals in Pregnancies Complicated With Neural Tube Defects
- ClinicalTrials.gov ID
- NCT04523233
- Acronym / sponsor ID
- NTD&HMs / CengizGWCH8
- Conditions
- Neural Tube Defects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cengiz Gokcek Women's and Children's HospitalUniversity, hospital or other
- Collaborators
- Bozok University
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 21 Aug 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.
Introduction: Heavy metals important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. The aims of this study were to determine the levels of trace elements and heavy metals, namely folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se), in the amniotic fluid of pregnant women, and to investigate their relationship with neural tube defects (NTDs).
Methods: The study will be included 70 pregnant women whose fetuses were complicated with NTDs (study group) and 70 pregnant women with unaffected healthy fetuses (control group). The samples levels of elements and vitamins will be measured using inductively coupled plasma-mass spectrometry and will be compared between the two groups.
Detailed description
Detailed Description:
This observational case-control study will be conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between August 2020 and March 2021. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2020/167). The study strictly will be adhered to the principles of the Declaration of Helsinki. All women will be provided written informed consent before the acquisition of all samples. The study will be included 140 pregnant women who underwent amniocentesis at the investigator's perinatology department.
The study group will be included 70 pregnant women whose fetuses were found to have congenital NTDs (eg, anencephaly, spina bifida, acrania, and encephalocele) on detailed ultrasonographic examinations between 16 and 37 weeks of pregnancy. The control group included pregnant women with healthy fetuses (n = 70), who were matched for gestational weeks and maternal age and underwent amniocentesis because of age-related risk or increased risk in the triple test. Then, this study will be determined maternal plasma/urine/hair, and amniotic fluid folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se) concentrations in women with NTD compared to those of volunteer healthy pregnant women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural tube defects (NTDs) | – | Diagnostic Test: AmniocentesisNTDs are a group of birth defects in which an opening in the spine or cranium remains from early in human development. Neural tube defects may be diagnosed during the ultrasound scan that is carried out around week 12 of the pregnancy or, more likely, during the anomaly scan that is carried out at around weeks 19 to 20. |
| Control group | – | Diagnostic Test: AmniocentesisThe control group will be included pregnant women with healthy fetuses (n = 70), who were matched for gestational weeks and maternal age and underwent amniocentesis because of age-related risk or increased risk in the triple test. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study group included 70 pregnant women with congenital NTDs (e.g. anencephaly, spina bifida, acrania, NTDs, and encephalocele) with a normal karyotype, which were detected in detailed ultrasonographic examinations, and 70 healthy pregnancies will be selected for the control group.
Key inclusion criteria (3 listed)
- Pregnant women complicated with Neural tube defects
- Healthy pregnancy
- Singleton pregnancy
Key exclusion criteria (9 listed)
- pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
- women who have dyed their hair in the last 5 months
- history of using any medication
- presence of gestational hypertension or gestational diabetes
- drug user
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 |
|---|---|---|
| AmniocentesisAlso: elements/vitamins concentrations measurementsAmniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment. | Diagnostic test | Control group, Neural tube defects (NTDs) |
Primary outcome
elements/vitamins concentrations in both group
Time frame: 1 week
The primary outcome in these analyses will compare folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminum (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se) concentrations in NTD group and control group.
1 secondary outcome
compore in NTDs group
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Results publication: PubMed 31743503Ovayolu A, Ovayolu G, Karaman E, Yuce T, Ozek MA, Turksoy VA. Amniotic fluid levels of selected trace elements and heavy metals in pregnancies complicated with neural tube defects. Congenit Anom (Kyoto). 2020 Sep;60(5):136-141. doi: 10.1111/cga.12363. Epub 2019 Nov 27.
- Results publication: PubMed 25375307Wilson RD; SOGC GENETICS COMMITTEE; SPECIAL CONTRIBUTOR. RETIRED: Prenatal screening, diagnosis, and pregnancy management of fetal neural tube defects. J Obstet Gynaecol Can. 2014 Oct;36(10):927-939. doi: 10.1016/S1701-2163(15)30444-8.
- Results publication: PubMed 27918138Yan L, Wang B, Li Z, Liu Y, Huo W, Wang J, Li Z, Ren A. Association of essential trace metals in maternal hair with the risk of neural tube defects in offspring. Birth Defects Res. 2017 Feb 15;109(3):234-243. doi: 10.1002/bdra.23594.
- Results publication: PubMed 28196803Nikolopoulou E, Galea GL, Rolo A, Greene ND, Copp AJ. Neural tube closure: cellular, molecular and biomechanical mechanisms. Development. 2017 Feb 15;144(4):552-566. doi: 10.1242/dev.145904.
- Individual participant dataSharing planned: Undecided
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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.
Cengiz Gokcek Women's and Child's hospital
Gaziantep, Turkey (Türkiye)
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 Neural Tube Defects, run by Cengiz Gokcek Women's and Children's Hospital 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elements/vitamins concentrations in both group (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04523233, which also lists 4 linked publications.
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 31 Aug 2021.