Metals and in Fetal Growth Restriction (FGR&metals)

Cengiz Gokcek Women's and Children's Hospital

Status: Unknown

Conditions: Fetal Growth Restriction

Treatments: Other: Obstetric ultrasound- doppler examination

Study type: Observational

Funder types: Other

Identifiers

NCT04394611

CengizGWCH6

Details and patient eligibility

About

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.

Full 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).

Enrollment: 55 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

55 participants in 2 patient groups

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

Treatment:

Other: Obstetric ultrasound- doppler examination

Control

Description:

healthy pregnancies will be selected for the control group.

Treatment:

Other: Obstetric ultrasound- doppler examination