Metals/Vitamins Levels in NTD

• Conditions: Neural Tube Defects
• Interventions: Diagnostic Test: Amniocentesis

• Registration Number: NCT04523233
• Lead Sponsor: Cengiz Gokcek Women's and Children's Hospital

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.

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 Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-21
• Study Start: 2020-08-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2021-10-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Amniocentesis	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.
Neural tube defects (NTDs)	Amniocentesis	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.

Primary Outcome Measures

Name	Time	Method
elements/vitamins concentrations in both group	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.

Secondary Outcome Measures

Name	Time	Method
compore in NTDs group	1 week	The secondary outcome in these analyses will compare the elements and vitamins concentrations in the spinal NTD group and the cranial NTD group.

Trial Locations

Locations (1)

Cengiz Gokcek Women's and Child's hospital; 🇹🇷 Gaziantep, Turkey