Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04394611
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2020-05-10
Brief Title:
Metals and in Fetal Growth Restriction
Sponsor:
Cengiz Gokcek Womens and Childrens Hospital
Organization:
Cengiz Gokcek Womens and Childrens Hospital
Study Overview
Official Title:
Analysis of Some Heavy Metals and Some Vitamins Levels in Maternal Samples Fetal Samples and Breast Milk for Fetal Growth Restriction
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FGRmetals
Brief Summary:
Introduction Intrauterine fetal growth restriction FGR is a condition in which the fetus does not realize its growth potential in the uterus Heavy metals important pollutants produced from anthropogenic activities has been suggested to be embryotoxic and fetotoxic in a lot of studies However the causes of fetal growth restriction are little known and heavy metals merit further investigation The investigators will be tested whether fetal growth restriction was associated with exposure to these metalsvitamins
Methods This study was designed to determine maternal plasmaurinehair cord plasma placenta and breast milk tin Sn manganese Mn Vanadium V Magnesium Mg cobalt Co nickel Ni arsenic As chromium Cr cadmium Cd lead Pb mercury Hg antimony Sb aluminium Al zinc Zn copper Cu selenium Se iron Fe vitamin D vitamin A vitamin B12 and folate concentrations in women with FGR n55 compared to those of volunteer healthy pregnant women n55 These heavy metals concentrations measured using inductively coupled plasma-mass spectrometry were compared
Methods This study was designed to determine maternal plasmaurinehair cord plasma placenta and breast milk tin Sn manganese Mn Vanadium V Magnesium Mg cobalt Co nickel Ni arsenic As chromium Cr cadmium Cd lead Pb mercury Hg antimony Sb aluminium Al zinc Zn copper Cu selenium Se iron Fe vitamin D vitamin A vitamin B12 and folate concentrations in women with FGR n55 compared to those of volunteer healthy pregnant women n55 These heavy metals concentrations measured using inductively coupled plasma-mass spectrometry were compared
Detailed Description:
This observational case-control study will be conducted at the Department of Obstetrics and Gynecology Cengiz Gokcek Public Hospital Gaziantep Turkey between May 2020 and February 2021 The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University reference no 2020131 The study strictly will be adhered to the principles of the Declaration of Helsinki All subjects will be included in the study gave oral and written informed consent FGR was defined as an estimated fetal weight grams less than the 10th percentile for gestational age Hadlock I formula were used to calculating estimated fetal weight percentiles Every woman in the study population will be undergone obstetric ultrasounddoppler examination and fetal-maternal assessment will be carried out Then this study will be determined maternal plasmaurinehair cord plasma placenta and breast milk tin Sn manganese Mn Vanadium V Magnesium Mg cobalt Co nickel Ni arsenic As chromium Cr cadmium Cd lead Pb mercury Hg antimony Sb aluminium Al zinc Zn copper Cu selenium Se iron Fe vitamin D vitamin A vitamin B12 and folate concentrations in women with FGR n55 compared to those of volunteer healthy pregnant women n55
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None