NCT04394611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

May 30, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

May 10, 2020

Last Update Submit

August 30, 2021

Conditions

Fetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • measurements of metals (µg/L) and vitamins concentrations for both groups

    The primary outcome in these analyses will measure 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), and iron (Fe) concentrations in FGR group and control group. Moreover, the other primary outcome in these analyses will also measure vitamin D, vitamin A, vitamin B12 and folate concentrations in FGR group and control group.

    10 day

Secondary Outcomes (1)

  • compare the neonatal outcomes for both groups

    1 day

Study Arms (2)

Fetal Growth Restriction (FGR)

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

Other: Obstetric ultrasound- doppler examination

Control

healthy pregnancies will be selected for the control group.

Other: Obstetric ultrasound- doppler examination

Interventions

Obstetric ultrasound- doppler examinationOTHER

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

Also known as: metals measurements
ControlFetal Growth Restriction (FGR)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The investigators consecutively will be recruited 55 subjects with Fetal growth restriction, and 55 healthy pregnancies will be selected for the control group.

You may qualify if:

  • Pregnant women complicated with fetal growth restriction
  • healthy pregnancy
  • singleton pregnancy

You may not qualify if:

  • pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
  • Women who have dyed their hair in the last 9 months
  • history of using any medication
  • Presence of gestational hypertension or gestational diabetes
  • drug user
  • patients who had fetal congenital abnormalities or genetic syndromes
  • multiple-gestation pregnancies
  • intrauterine fetal death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • Xiong YW, Zhu HL, Nan Y, Cao XL, Shi XT, Yi SJ, Feng YJ, Zhang C, Gao L, Chen YH, Xu DX, Wang H. Maternal cadmium exposure during late pregnancy causes fetal growth restriction via inhibiting placental progesterone synthesis. Ecotoxicol Environ Saf. 2020 Jan 15;187:109879. doi: 10.1016/j.ecoenv.2019.109879. Epub 2019 Oct 31.

    PMID: 31677567RESULT

  • Eroglu H, Turgal M, Senat A, Karakoc G, Neselioglu S, Yucel A. Maternal and fetal thiol/disulfide homeostasis in fetal growth restriction. J Matern Fetal Neonatal Med. 2021 May;34(10):1658-1665. doi: 10.1080/14767058.2019.1646239. Epub 2019 Aug 5.

    PMID: 31327276RESULT

  • Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884.

    PMID: 26909664RESULT

  • Jiang M, Li Y, Zhang B, Zhou A, Zheng T, Qian Z, Du X, Zhou Y, Pan X, Hu J, Wu C, Peng Y, Liu W, Zhang C, Xia W, Xu S. A nested case-control study of prenatal vanadium exposure and low birthweight. Hum Reprod. 2016 Sep;31(9):2135-41. doi: 10.1093/humrep/dew176. Epub 2016 Jul 4.

    PMID: 27381766RESULT

  • Sabra S, Malmqvist E, Saborit A, Gratacos E, Gomez Roig MD. Heavy metals exposure levels and their correlation with different clinical forms of fetal growth restriction. PLoS One. 2017 Oct 6;12(10):e0185645. doi: 10.1371/journal.pone.0185645. eCollection 2017.

    PMID: 28985223RESULT

  • Ovayolu A, Ovayolu G, Karaman E, Yuce T, Ozek MA, Turksoy VA. Amniotic fluid levels of selected trace elements and heavy metals in pregnancies complicated with neural tube defects. Congenit Anom (Kyoto). 2020 Sep;60(5):136-141. doi: 10.1111/cga.12363. Epub 2019 Nov 27.

    PMID: 31743503RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

maternal plasma/urine/hair, cord plasma, placenta and breast milk

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 19, 2020

Study Start

May 30, 2020

Primary Completion

November 28, 2021

Study Completion

December 30, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)