Fetal Growth RestrictionFGR&metalsNCT04394611
Metals and in Fetal Growth Restriction
An observational study of Fetal Growth Restriction, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction
- What is being tested?
- Obstetric ultrasound- doppler examination
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Pregnant women complicated with fetal growth restriction
- healthy pregnancy
- singleton pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cengiz Gokcek Women's and Child's hospital
Gaziantep, 27010
Ali Ovayolu, MD, 00905326404060, drovayolu@yahoo.com
About this study
Official title: Analysis of Some Heavy Metals and Some Vitamins Levels in Maternal Samples, Fetal Samples and Breast Milk for Fetal Growth Restriction.
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.
Read the 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
- Being tested
- Obstetric ultrasound- doppler examination
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric ultrasound- doppler examinationOther
Also called metals measurements
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Obstetric ultrasound- doppler examination | |
| Control | healthy pregnancies will be selected for the control group. Receives: Other: Obstetric ultrasound- doppler examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 day
Secondary outcomes (1)
compare the neonatal outcomes for both groups
The secondary outcome in these analyses will compare composite neonatal outcome (APGAR scores, weight, length, head circumference, abdominal circumference, placental weight and NICU admission) in FGR group and control group.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start30 May 2020
- Primary completion28 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cengiz Gokcek Women's and Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394611
- Sponsor's protocol ID
- CengizGWCH6
- Acronym
- FGR&metals
- Status last verified
- Aug 2021
- First submitted
- 10 May 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31677567Eroglu 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.
PubMed 31327276Gordijn 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.
PubMed 26909664Jiang 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.
PubMed 27381766Sabra 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.
PubMed 28985223Ovayolu 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.
PubMed 31743503
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Some Heavy Metals and Some Vitamins Levels in Maternal Samples, Fetal Samples and Breast Milk for Fetal Growth Restriction.
- ClinicalTrials.gov ID
- NCT04394611
- Acronym / sponsor ID
- FGR&metals / CengizGWCH6
- Conditions
- Fetal Growth Restriction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Cengiz Gokcek Women's and Children's HospitalUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 28 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal Growth Restriction (FGR) | – | Other: Obstetric ultrasound- doppler examinationFGR 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 |
| Control | – | Other: Obstetric ultrasound- doppler examinationhealthy pregnancies will be selected for the control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Pregnant women complicated with fetal growth restriction
- healthy pregnancy
- singleton pregnancy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric ultrasound- doppler examinationAlso: metals measurementsObstetric 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 | Control, Fetal Growth Restriction (FGR) |
Primary outcome
measurements of metals (µg/L) and vitamins concentrations for both groups
Time frame: 10 day
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.
1 secondary outcome
compare the neonatal outcomes for both groups
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Results publication: PubMed 31677567Xiong 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.
- Results publication: PubMed 31327276Eroglu 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.
- Results publication: PubMed 26909664Gordijn 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.
- Results publication: PubMed 27381766Jiang 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.
- Results publication: PubMed 28985223Sabra 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.
- Results publication: PubMed 31743503Ovayolu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cengiz Gokcek Women's and Child's hospital
Gaziantep, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of metals (µg/L) and vitamins concentrations for both groups (time frame: 10 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394611, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.