Metals/Vitamins Levels in NTD

Neural Tube Defects Clinical Trial

— NTD&HMs  

Official title:

Maternal Plasma/Urine/Hair/Amniotic Fluid Levels of Selected Trace Elements and Heavy Metals in Pregnancies Complicated With Neural Tube Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04523233
• Other study ID #: CengizGWCH8
• Status: Recruiting
• Start date: August 25, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2021
• Source: Cengiz Gokcek Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 28, 2022
• Est. primary completion date: October 30, 2021
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women complicated with Neural tube defects

• Healthy pregnancy

• Singleton pregnancy

Exclusion Criteria:

1. pregnant women with any systemic condition (such as chronic hypertension, renal disease and )

2. women who have dyed their hair in the last 5 months

3. history of using any medication

4. presence of gestational hypertension or gestational diabetes

5. drug user

6. patients who had other fetal congenital abnormalities or genetic syndromes

7. multiple-gestation pregnancies

8. intrauterine fetal death

9. oligohydramnios

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Intervention

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

Locations

Country	Name	City	State
Turkey	Cengiz Gokcek Women's and Child's hospital	Gaziantep

Sponsors (2)

Lead Sponsor	Collaborator
Cengiz Gokcek Women's and Children's Hospital	The Scientific Research Project Fund of Yozgat Bozok University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View Citation

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. Epu — View Citation

Wilson RD; SOGC GENETICS COMMITTEE; SPECIAL CONTRIBUTOR. 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 week