NTD&HMs: Metals/Vitamins Levels in NTD

Sponsor

Cengiz Gokcek Women's and Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04523233

Collaborator

The Scientific Research Project Fund of Yozgat Bozok University (Other)

140

Enrollment

Location

18.1

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neural Tube Defects	Diagnostic Test: Amniocentesis

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

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 25, 2020

Anticipated Primary Completion Date :

Oct 30, 2021

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment. Other Names: elements/vitamins concentrations measurements
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 Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment. Other Names: elements/vitamins concentrations measurements

Arm

Intervention/Treatment

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

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

Other Names:

elements/vitamins concentrations measurements

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

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

Other Names:

elements/vitamins concentrations measurements

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

Pregnant women complicated with Neural tube defects
Healthy pregnancy
Singleton pregnancy

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cengiz Gokcek Women's and Child's hospital	Gaziantep		Turkey	27010

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Aug 15, 2020

More Information

Publications

None provided.

Responsible Party:

Ali Ovayolu, Principal Investigator, Cengiz Gokcek Women's and Children's Hospital

ClinicalTrials.gov Identifier:

NCT04523233

Other Study ID Numbers:

CengizGWCH8

First Posted:

Aug 21, 2020

Last Update Posted:

Aug 31, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neural Tube Defects

Spinal Dysraphism

Vitamins

Study Results

No Results Posted as of Aug 31, 2021