Metals/Vitamins Levels in NTD (NTD&HMs)

August 30, 2021 updated by: Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27010
        • Recruiting
        • Cengiz Gokcek Women's and Child's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compore in NTDs group
Time Frame: 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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cengiz Gokcek Women's and Children's Hospital

Collaborators

The Scientific Research Project Fund of Yozgat Bozok University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CengizGWCH8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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