Metals/Vitamins Levels in NTD

NCT04523233 | Unknown

• 1 other identifier: CengizGWCH8
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Neural Tube Defects

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (1)

• compore in NTDs group

  1 week

Study Arms (2)

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.

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.

Diagnostic Test: Amniocentesis

Interventions

Amniocentesis DIAGNOSTIC_TEST

Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment.

Also known as: elements/vitamins concentrations measurements

Control group; Neural tube defects (NTDs)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnancy
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Pregnant women complicated with Neural tube defects
• Healthy pregnancy
• Singleton pregnancy

You may not qualify if:

• 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
• multiple-gestation pregnancies
• intrauterine fetal death
• oligohydramnios

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead
• The Scientific Research Project Fund of Yozgat Bozok University: collaborator

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 31743503 RESULT

• Wilson 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.

  PMID: 25375307 RESULT

• Yan 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.

  PMID: 27918138 RESULT

• Nikolopoulou 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.

  PMID: 28196803 RESULT

MeSH Terms

Conditions

Neural Tube Defects

Interventions

Amniocentesis

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: August 25, 2020
• Primary Completion: October 30, 2021
• Study Completion: February 28, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

TU (1)