NCT04394611

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Cengiz Gokcek Women's and Children's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Fetal Growth Restriction

Interventions

Type	Name	Description
OTHER	Obstetric ultrasound- doppler examination	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

Timeline

• Start date: 2020-05-30
• Primary completion: 2021-11-28
• Completion: 2021-12-30
• First posted: 2020-05-19
• Last updated: 2021-08-31

Locations

1 site across 1 country: Turkey (Türkiye)