Neural Tube Defects
Conditions
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.
Interventions
DIAGNOSTIC_TESTAmniocentesis
Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment.
Sponsors
The Scientific Research Project Fund of Yozgat Bozok University
Cengiz Gokcek Women's and Children's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed