Metals and in Fetal Growth Restriction

Analysis of Some Heavy Metals and Some Vitamins Levels in Maternal Samples, Fetal Samples and Breast Milk for Fetal Growth Restriction.

Sponsors

Lead Sponsor: Cengiz Gokcek Women's and Children's Hospital

Source Cengiz Gokcek Women's and Children's Hospital
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 metals/vitamins. Methods: This study was designed to determine maternal plasma/urine/hair, 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 (n=55) compared to those of volunteer healthy pregnant women (n=55). 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: 2020/131). 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 ultrasound/doppler examination and fetal-maternal assessment will be carried out. Then, this study will be determined maternal plasma/urine/hair, 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 (n=55) compared to those of volunteer healthy pregnant women (n=55).

Overall Status Recruiting
Start Date May 30, 2020
Completion Date March 30, 2021
Primary Completion Date February 28, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
measurements of metals (µg/L) and vitamins concentrations for both groups 10 day
Secondary Outcome
Measure Time Frame
compare the neonatal outcomes for both groups 1 day
Enrollment 55
Condition
Intervention

Intervention Type: Other

Intervention Name: Obstetric ultrasound- doppler examination

Description: Obstetric ultrasound- doppler examination and fetal- maternal assessment Tin (Sn), manganese (Mn), Vanadium (V), Magnesium (Mg), cobalt (Co), nickel (Ni), arsenic (As), chromium (Cr), cadmium (Cd), lead (Pb), mercury (Hg), antimony (Sb), aluminum (Al), zinc (Zn), copper (Cu), selenyum (Se), iron (Fe), vitamin D, vitamin A, vitamin B12 and folate concentrations measurements

Other Name: metals measurements

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria: - Pregnant women complicated with fetal growth restriction - 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 9 months 3. history of using any medication 4. Presence of gestational hypertension or gestational diabetes 5. drug user 6. patients who had fetal congenital abnormalities or genetic syndromes 7. multiple-gestation pregnancies 8. intrauterine fetal death

Gender: Female

Gender Based: Yes

Gender Description: Pregnancy

Minimum Age: 18 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Status: Contact: Cengiz Gokcek Women's and Child's hospital Ali Ovayolu, MD 00905326404060 [email protected]
Location Countries

Turkey

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cengiz Gokcek Women's and Children's Hospital

Investigator Full Name: Ali Ovayolu

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Arm Group

Label: Fetal Growth Restriction (FGR)

Description: FGR will be defined as an estimated fetal weight (grams) less than the 10th percentile for gestational age. Hadlock I formula will be used to calculating estimated fetal weight percentiles

Label: Control

Description: healthy pregnancies will be selected for the control group.

Acronym FGR&metals
Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov