PreeclampsiaV-Mg&PrENCT04387565
Magnesium and Vanadium Levels in Preeclampsia
An observational study of Preeclampsia, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Vanadium important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. Magnesium sulfate therapy is used very common to prevent seizures in women with preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- magnesium and vanadium measurements and compare
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 30 Nov 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
- Adult
Study population: The investigators consecutively will be recruited 70 late-onset preeclampsia patients as a study group, 70 participants with normal pregnancies as control pregnant group and 70 participants with healthy volunteer women as control non-pregnant group.
Who may be able to join
- preeclampsia
- healthy pregnancy
- healthy women
Who cannot join
- pregnant women with any systemic condition (such as chronic hypertension, renal disease and diabetes mellitus)
- using any kind of medication/supplement intake throughout pregnancy (such as heparin)
- history of medication for PE treatment at the time of first admission
- smoking
- drug user
- patients who had fetal congenital abnormalities or genetic syndromes
Show all 14Show fewer
- multiple-gestation pregnancies
- pregnancies resulting from in vitro fertilization
- intrauterine fetal death
- having a family history of preeclampsia
- Women who have menstrual irregularity
- Women who have dyed their hair in the last 9 months
- Gestational diabetes mellitus
- Women receiving vanadium and/or magnesium treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cengiz Gokcek Women's and Child's hospital
Gaziantep, 27010
About this study
Official title: Analysis of Maternal Plasma/Urine/Hair Magnesium and Vanadium Levels in Preeclampsia (PrE)
Introduction: Vanadium important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. Magnesium sulfate therapy is used very common to prevent seizures in women with preeclampsia. However, the causes of preeclampsia are little known and heavy metals merit further investigation. The investigators will be tested whether late - onset preeclampsia (LOPE) was associated with exposure to these metals.
Methods: This study was designed to determine maternal plasma/urine/hair magnesium and vanadium concentrations in women with LOPE (n=70) compared to those of normotensive pregnant women (n=70) and to those of normotensive-healthy non-pregnant women (n=70). These metals concentrations will be 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: 2020/130). The study strictly will be adhered to the principles of the Declaration of Helsinki. All participants will be included in the study gave oral and written informed consent. Two-hundred ten women will be enrolled in the study in three groups.
- Conditions
- Preeclampsia
- Being tested
- magnesium and vanadium measurements and compare
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium and vanadium measurements and compareOther
Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia | The diagnosis of LOPE, as will be defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will be established based on the presence of proteinuria and a blood pressure level of ≥140/90 mmHg that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure ≥ 160/110 mm Hg, it will be accepted as mild; and in case these values exceeded this level, it will be accepted as severe. Receives: Other: magnesium and vanadium measurements and compare | |
| control pregnant group | These participants with normal healthy pregnancies at the third trimester (before birth) Receives: Other: magnesium and vanadium measurements and compare | |
| control non-pregnant group | A volunteer group of healthy women who visited the gynaecology clinic for routine examinations and women who were admitted for pre-pregnancy tests were invited randomly to this research as a control group. Receives: Other: magnesium and vanadium measurements and compare |
What is being measured
The primary outcome is the main question the study is designed to answer.
magnesium and vanadium levels
The primary outcome in these analyses will be magnesium and vanadium levels in LOPE group and control groups.
Measured: 10 day
Secondary outcomes (1)
magnesium and vanadium levels in severy LOPE group
The secondary outcome will be compare the magnesium and vanadium levels in mild LOPE group and severy LOPE 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 posted14 May 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2021
- Study completion30 Nov 2021
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 PreeclampsiaStudies 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
- 210 participants (actual)
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
- Investigators
- Ali Ovayolu, MD, Principal investigator, Cengiz Gökçek Kadın Doğum Ve Çocuk Hastalıkları Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387565
- Sponsor's protocol ID
- CengizGWCH7
- Acronym
- V-Mg&PrE
- Status last verified
- Aug 2024
- First submitted
- 10 May 2020
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31743503Scibior A. Vanadium (V) and magnesium (Mg) - In vivo interactions: A review. Chem Biol Interact. 2016 Oct 25;258:214-33. doi: 10.1016/j.cbi.2016.09.007. Epub 2016 Sep 13.
PubMed 27620816Elongi Moyene JP, Scheers H, Tandu-Umba B, Haufroid V, Buassa-Bu-Tsumbu B, Verdonck F, Spitz B, Nemery B. Preeclampsia and toxic metals: a case-control study in Kinshasa, DR Congo. Environ Health. 2016 Apr 5;15:48. doi: 10.1186/s12940-016-0132-1.
PubMed 27044488Euser AG, Cipolla MJ. Magnesium sulfate for the treatment of eclampsia: a brief review. Stroke. 2009 Apr;40(4):1169-75. doi: 10.1161/STROKEAHA.108.527788. Epub 2009 Feb 10.
PubMed 19211496Jiang 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 27381766Ovayolu A, Turksoy VA, Turan AI, Dogan I, Bostancieri N. Does magnesium, one of the treatments for preeclampsia, interact with vanadium? Naunyn Schmiedebergs Arch Pharmacol. 2026 Feb;399(3):3447-3459. doi: 10.1007/s00210-025-04609-7. Epub 2025 Sep 29.
PubMed 41020941
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Maternal Plasma/Urine/Hair Magnesium and Vanadium Levels in Preeclampsia (PrE)
- ClinicalTrials.gov ID
- NCT04387565
- Acronym / sponsor ID
- V-Mg&PrE / CengizGWCH7
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Cengiz Gokcek Women's and Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 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: Vanadium important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. Magnesium sulfate therapy is used very common to prevent seizures in women with preeclampsia. However, the causes of preeclampsia are little known and heavy metals merit further investigation. The investigators will be tested whether late - onset preeclampsia (LOPE) was associated with exposure to these metals.
Methods: This study was designed to determine maternal plasma/urine/hair magnesium and vanadium concentrations in women with LOPE (n=70) compared to those of normotensive pregnant women (n=70) and to those of normotensive-healthy non-pregnant women (n=70). These metals concentrations will be 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: 2020/130). The study strictly will be adhered to the principles of the Declaration of Helsinki. All participants will be included in the study gave oral and written informed consent. Two-hundred ten women will be enrolled in the study in three groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia | – | Other: magnesium and vanadium measurements and compareThe diagnosis of LOPE, as will be defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will be established based on the presence of proteinuria and a blood pressure level of ≥140/90 mmHg that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure ≥ 160/110 mm Hg, it will be accepted as mild; and in case these values exceeded this level, it will be accepted as severe. |
| control pregnant group | – | Other: magnesium and vanadium measurements and compareThese participants with normal healthy pregnancies at the third trimester (before birth) |
| control non-pregnant group | – | Other: magnesium and vanadium measurements and compareA volunteer group of healthy women who visited the gynaecology clinic for routine examinations and women who were admitted for pre-pregnancy tests were invited randomly to this research as a control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The investigators consecutively will be recruited 70 late-onset preeclampsia patients as a study group, 70 participants with normal pregnancies as control pregnant group and 70 participants with healthy volunteer women as control non-pregnant group.
Key inclusion criteria (3 listed)
- preeclampsia
- healthy pregnancy
- healthy women
Key exclusion criteria (14 listed)
- pregnant women with any systemic condition (such as chronic hypertension, renal disease and diabetes mellitus)
- using any kind of medication/supplement intake throughout pregnancy (such as heparin)
- history of medication for PE treatment at the time of first admission
- smoking
- 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 |
|---|---|---|
| magnesium and vanadium measurements and compareMagnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA). | Other | Preeclampsia, control non-pregnant group, control pregnant group |
Primary outcome
magnesium and vanadium levels
Time frame: 10 day
The primary outcome in these analyses will be magnesium and vanadium levels in LOPE group and control groups.
1 secondary outcome
magnesium and vanadium levels in severy LOPE group
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- 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.
- Results publication: PubMed 27620816Scibior A. Vanadium (V) and magnesium (Mg) - In vivo interactions: A review. Chem Biol Interact. 2016 Oct 25;258:214-33. doi: 10.1016/j.cbi.2016.09.007. Epub 2016 Sep 13.
- Results publication: PubMed 27044488Elongi Moyene JP, Scheers H, Tandu-Umba B, Haufroid V, Buassa-Bu-Tsumbu B, Verdonck F, Spitz B, Nemery B. Preeclampsia and toxic metals: a case-control study in Kinshasa, DR Congo. Environ Health. 2016 Apr 5;15:48. doi: 10.1186/s12940-016-0132-1.
- Results publication: PubMed 19211496Euser AG, Cipolla MJ. Magnesium sulfate for the treatment of eclampsia: a brief review. Stroke. 2009 Apr;40(4):1169-75. doi: 10.1161/STROKEAHA.108.527788. Epub 2009 Feb 10.
- 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.
- Derived from this study: PubMed 41020941Ovayolu A, Turksoy VA, Turan AI, Dogan I, Bostancieri N. Does magnesium, one of the treatments for preeclampsia, interact with vanadium? Naunyn Schmiedebergs Arch Pharmacol. 2026 Feb;399(3):3447-3459. doi: 10.1007/s00210-025-04609-7. Epub 2025 Sep 29.
- 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.
Ali Ovayolu, MD principal investigator
Cengiz Gökçek Kadın Doğum Ve Çocuk Hastalıkları Hastanesi
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 Preeclampsia, 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 14 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: finished, as of the sponsor's last update on 28 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
magnesium and vanadium levels (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 NCT04387565, 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 28 Aug 2024.