Pregnancy; Disorder, BloodPREDISHNCT03598361
Mineral Status in Pregnant Women
An observational study of Pregnancy; Disorder, Blood, run by Poznan University of Life Sciences at 1 site in Poland.
Trial summary
Ensuring an adequate supply of nutrients, which include trace elements, is particularly important in pregnancy. Both deficiency and excess of trace elements in the body can interfere with conception and maintaining a healthy pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy; Disorder, Blood
- How many people
- 550 participants
- Where
- 1 sitePoland
- Study dates
- 20 Mar 2018to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A group of approximately 300 women is planned to be included in the study in the first trimester of pregnancy (up to 14 weeks of pregnancy).
Who may be able to join
- Diagnosed intrauterine pregnancy until week 14.
- Single pregnancy without congenital malformations in ultrasound examination.
- Lack of exponents threatening miscarriage (bleeding, lower abdominal pain, chorionic hematoma).
- Lack of use of drugs affecting the mineral metabolism of the body.
- Signing consent to participate in the study.
Who cannot join
- Ectopic or heterotopic pregnancy.
- Twin pregnancy (or other multiple pregnancy).
- Obstetric load in the direction of numerous miscarriages, premature births under 34 weeks, pregnancy, fetal growth disorders (hypotrophy, macrosomia).
- Congenital and /or genetic defects found in current pregnancy or in the patient.
- Supply of drugs affecting the mineral metabolism of the body.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Life Sciences
Poznan, 60-624
Joanna Suliburska, Assoc. Prof., +48 618487334, jsulibur@up.poznan.pl
About this study
Official title: Evaluation of Mineral Status in Pregnant Women and Its Association With Fetal Development
Ensuring an adequate supply of nutrients, which include trace elements, is particularly important in pregnancy. Both deficiency and excess of trace elements in the body can interfere with conception and maintaining a healthy pregnancy. The effects of malnutrition and shortages in fetal life may increase the risk of miscarriages, congenital malformations, premature births, intrauterine fetal growth restriction (IUGR) and more frequent perinatal mortality. Nutritional deficiencies during fetal development may also have long-term consequences for the child, such as disorders in his biological and psychomotor development.
In women of procreative age, an adequate supply of minerals, especially iron, calcium, zinc, magnesium and copper, is very important. The results of clinical trials indicate an association of anemia in pregnant women with premature delivery and low birth weight of a newborn. Calcium deficiency leads to the development of hypertension in pregnancy (including preeclampsia) and increases the risk of premature birth. Deficiency of zinc and copper in the mother's body is associated with complications of pregnancy and childbirth and affects inappropriate fetal development.
Read more
The deficiency of these mineral components is often observed in young women-potential mothers. Increasing during pregnancy the need for nutrients and abnormal nutrition, intensify the deficiencies of minerals and affect the abnormal development of the fetus. It seems that during the course of pregnancy, changes in the mineral nutrition of women can be observed, which is why it is important to monitor this condition in the subsequent months of pregnancy.
Due to the above, the aim of the planned research is to determine the nutrition and nutritional status of women in the subsequent trimesters of pregnancy.
Obtained results will allow to formulate appropriate nutritional recommendations and / or indicate the need to implement appropriate mineral supplementation for women in every trimester of pregnancy.
Read the detailed description
Assumptions of the research, description of the study group (age, sex, health status, size of the group):
The review of literature on the subject shows that there are relationships between the concentrations of certain elements (especially magnesium, copper, cadmium and barium), and the gestational age and fetal biometric parameters. Scientific research carried out so far has also pointed to the relationship between pregnancy-related diseases (pre-eclampsia, intra-uterine growth disorders) and the mineral status of pregnant women. Little is known about the minerals concentration in amniotic fluid. The main aim of the study is to determine the correlation between the mineral status of pregnant women and the course of pregnancy and fetal development. During the tests, the concentrations of selected mineral components in the maternal blood serum, amniotic fluid and the hair of pregnant women will be determined. The obtained data will be combined with dietary data obtained through a questionnaire and nutrition journal. The dependence between the content of minerals in the analyzed material and the fetus development, the health of the newborn and the course of pregnancy will also be assessed. Clear identification of the correlation between the mineral status of pregnant women and the course of pregnancy and fetal development may be an important contribution to the development of science about nutrition during pregnancy and prenatal diagnosis and prevention of pregnancy complications.
The importance of research:
The review of the literature on the subject shows that there are few studies showing correlations between the concentration of minerals in various compartments of the pregnant woman's body, and the course of pregnancy and fetal development. There is also a lack of data on the relationship between diet and supplementation during pregnancy and the mineral status of pregnant women.
The planned studies are intended to determine the concentration of minerals, e.g. in materials such as blood serum, amniotic fluid, or hair. Elemental analysis of hair will allow assessment of long-term nutritional status of women with mineral components. The mineral composition of amniotic fluid, according to literature data, requires further analysis. It is suggested that amniotic fluid may be an important diagnostic material for deficiencies of minerals during pregnancy.
Amniotic fluid is necessary for the proper development of the embryo and fetus. It participates, among others, in nourishing and protecting the newly developing organism and performing information role in diagnostic procedures. The water contained in the amniotic fluid comes originally from maternal plasma and penetrates through the fetal membranes on the hydrostatic and osmotic way. As the placenta and fetal vessels develop, water and substances dissolved in maternal plasma pass through the placenta to the fetus and then into the amniotic fluid. In the period from 10 to 20 weeks of pregnancy, the composition of amniotic fluid is similar to that of fetal plasma. During this time, rapid bilateral diffusion between the fetus and amniotic fluid is observed through the non-keratinized fetal skin and amniotic surfaces, placenta and umbilical cord, which are easily permeable to water and substances dissolved in it. The composition of the amniotic fluid depends largely on the mother's nutritional status and on the exposure of her body to toxic substances. The role of minerals contained in the amniotic fluid is not clear. Due to the fact that the fetus swallows amniotic fluid, it may be a significant nutrient source for him. For this reason, it is suggested that the content of elements in the amniotic fluid may be a valuable marker of the nutritional status of the fetus and its exposure to toxic compounds.
In summary, the relationship between the concentration of minerals contained in amniotic fluid, mother's blood serum and hair with the development of the fetus and the occurrence of diseases complicating pregnancy requires further analysis. Planned research can significantly contribute to expanding knowledge in this topic. Based on the extremely important role of minerals in the normal functioning of the body of an adult human, it is particularly reasonable to conduct research to determine their significance at the stage of fetal life.
Research goals:
- Prospective determination of the concentration of selected, essential and toxic elements in the blood serum of women in the second trimester of pregnancy.
- Prospective determination of the concentration of selected, essential and toxic elements in the amniotic fluid.
- Prospective determination of the concentration of selected, essential and toxic elements in hair taken from women in the second trimester of pregnancy.
- Determination of the correlation between mineral components in the amniotic fluid, hair and mother's serum and parameters of fetal development and the state of health of the newborn.
- Prospective determination of the diet of pregnant women, with particular emphasis on the supply of minerals.
- Determination of the correlation between the diet of pregnant women and the concentration of selected minerals in amniotic fluid, mother's blood serum and hair.
Research assumptions:
Material for prospective studies will be collected during standard diagnostic procedures for patients at the gynecology and obstetrics clinic.
On the day of inclusion in the study, the patient will be collected blood from the ulnar vein - 5ml as part of a routine prenatal visit.
The following will be marked in the blood serum:
- concentration of minerals,
- placental capacity markers (pregnancy associated plasma protein A (PAPP-A), human chorionic gonadotropin (HCG), alfa-fetoprotein (AFP)).
The hair sample (about 0.5 g) from pregnant women will be taken on the day of inclusion in the study.
The pregnant women will be asked to complete a 3-day nutritional interview and nutritional survey.
From patients qualified for invasive prenatal diagnosis (amniocentesis), a sample of amniotic fluid (5 ml) will be taken, in which, in addition to the standardly evaluated parameters, selected mineral components will be marked.
Amniotic fluid samples will be collected during the routine amniocentesis procedure in patients with prenatal indications in 15-30 weeks of pregnancy.
- Conditions
- Pregnancy; Disorder, Blood
- Keywords
- pregnancy outcomes, minerals
What is being measured
The primary outcome is the main question the study is designed to answer.
minerals (Ca, Mg, Fe, Zn)
measure minerals in serum, hair, amniotic fluid
Measured: 1 year
Secondary outcomes (8)
maternal anthropometric parameters
measure weight in kilograms
Measured: 2 years
fetal body weight
measure body weight according to ultrasound
Measured: 2 years
fetal head circumference
measure head circumference according to ultrasound procedures
Measured: 2 years
fetal biparietal diameter
measure biparietal diameter according to ultrasound procedures
Measured: 2 years
prenatal diagnosis: PAPP-A
measure PAPP-A in maternal serum
Measured: 2 years
prenatal diagnosis: HCG
measure HCG in maternal serum
Measured: 2 years
prenatal diagnosis: AFP
measure AFP in maternal serum
Measured: 2 years
dietary intake
measure energy, fat, proteins, carbohydrates and minerals intake
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start20 Mar 2018
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy; Disorder, BloodStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Suliburska, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598361
- Sponsor's protocol ID
- 297/17
- Acronym
- PREDISH
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2018
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mineral Status in Pregnant Women and Its Association With Fetal Development
- ClinicalTrials.gov ID
- NCT03598361
- Acronym / sponsor ID
- PREDISH / 297/17
- Conditions
- Pregnancy; Disorder, Blood
- Keywords
- pregnancy outcomes, minerals
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Jul 2018 (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.
Ensuring an adequate supply of nutrients, which include trace elements, is particularly important in pregnancy. Both deficiency and excess of trace elements in the body can interfere with conception and maintaining a healthy pregnancy. The effects of malnutrition and shortages in fetal life may increase the risk of miscarriages, congenital malformations, premature births, intrauterine fetal growth restriction (IUGR) and more frequent perinatal mortality. Nutritional deficiencies during fetal development may also have long-term consequences for the child, such as disorders in his biological and psychomotor development.
In women of procreative age, an adequate supply of minerals, especially iron, calcium, zinc, magnesium and copper, is very important. The results of clinical trials indicate an association of anemia in pregnant women with premature delivery and low birth weight of a newborn. Calcium deficiency leads to the development of hypertension in pregnancy (including preeclampsia) and increases the risk of premature birth. Deficiency of zinc and copper in the mother's body is associated with complications of pregnancy and childbirth and affects inappropriate fetal development.
The deficiency of these mineral components is often observed in young women-potential mothers. Increasing during pregnancy the need for nutrients and abnormal nutrition, intensify the deficiencies of minerals and affect the abnormal development of the fetus. It seems that during the course of pregnancy, changes in the mineral nutrition of women can be observed, which is why it is important to monitor this condition in the subsequent months of pregnancy.
Due to the above, the aim of the planned research is to determine the nutrition and nutritional status of women in the subsequent trimesters of pregnancy.
Obtained results will allow to formulate appropriate nutritional recommendations and / or indicate the need to implement appropriate mineral supplementation for women in every trimester of pregnancy.
Detailed description
Assumptions of the research, description of the study group (age, sex, health status, size of the group):
The review of literature on the subject shows that there are relationships between the concentrations of certain elements (especially magnesium, copper, cadmium and barium), and the gestational age and fetal biometric parameters. Scientific research carried out so far has also pointed to the relationship between pregnancy-related diseases (pre-eclampsia, intra-uterine growth disorders) and the mineral status of pregnant women. Little is known about the minerals concentration in amniotic fluid. The main aim of the study is to determine the correlation between the mineral status of pregnant women and the course of pregnancy and fetal development. During the tests, the concentrations of selected mineral components in the maternal blood serum, amniotic fluid and the hair of pregnant women will be determined. The obtained data will be combined with dietary data obtained through a questionnaire and nutrition journal. The dependence between the content of minerals in the analyzed material and the fetus development, the health of the newborn and the course of pregnancy will also be assessed. Clear identification of the correlation between the mineral status of pregnant women and the course of pregnancy and fetal development may be an important contribution to the development of science about nutrition during pregnancy and prenatal diagnosis and prevention of pregnancy complications.
The importance of research:
The review of the literature on the subject shows that there are few studies showing correlations between the concentration of minerals in various compartments of the pregnant woman's body, and the course of pregnancy and fetal development. There is also a lack of data on the relationship between diet and supplementation during pregnancy and the mineral status of pregnant women.
The planned studies are intended to determine the concentration of minerals, e.g. in materials such as blood serum, amniotic fluid, or hair. Elemental analysis of hair will allow assessment of long-term nutritional status of women with mineral components. The mineral composition of amniotic fluid, according to literature data, requires further analysis. It is suggested that amniotic fluid may be an important diagnostic material for deficiencies of minerals during pregnancy.
Amniotic fluid is necessary for the proper development of the embryo and fetus. It participates, among others, in nourishing and protecting the newly developing organism and performing information role in diagnostic procedures. The water contained in the amniotic fluid comes originally from maternal plasma and penetrates through the fetal membranes on the hydrostatic and osmotic way. As the placenta and fetal vessels develop, water and substances dissolved in maternal plasma pass through the placenta to the fetus and then into the amniotic fluid. In the period from 10 to 20 weeks of pregnancy, the composition of amniotic fluid is similar to that of fetal plasma. During this time, rapid bilateral diffusion between the fetus and amniotic fluid is observed through the non-keratinized fetal skin and amniotic surfaces, placenta and umbilical cord, which are easily permeable to water and substances dissolved in it. The composition of the amniotic fluid depends largely on the mother's nutritional status and on the exposure of her body to toxic substances. The role of minerals contained in the amniotic fluid is not clear. Due to the fact that the fetus swallows amniotic fluid, it may be a significant nutrient source for him. For this reason, it is suggested that the content of elements in the amniotic fluid may be a valuable marker of the nutritional status of the fetus and its exposure to toxic compounds.
In summary, the relationship between the concentration of minerals contained in amniotic fluid, mother's blood serum and hair with the development of the fetus and the occurrence of diseases complicating pregnancy requires further analysis. Planned research can significantly contribute to expanding knowledge in this topic. Based on the extremely important role of minerals in the normal functioning of the body of an adult human, it is particularly reasonable to conduct research to determine their significance at the stage of fetal life.
Research goals:
- Prospective determination of the concentration of selected, essential and toxic elements in the blood serum of women in the second trimester of pregnancy.
- Prospective determination of the concentration of selected, essential and toxic elements in the amniotic fluid.
- Prospective determination of the concentration of selected, essential and toxic elements in hair taken from women in the second trimester of pregnancy.
- Determination of the correlation between mineral components in the amniotic fluid, hair and mother's serum and parameters of fetal development and the state of health of the newborn.
- Prospective determination of the diet of pregnant women, with particular emphasis on the supply of minerals.
- Determination of the correlation between the diet of pregnant women and the concentration of selected minerals in amniotic fluid, mother's blood serum and hair.
Research assumptions:
Material for prospective studies will be collected during standard diagnostic procedures for patients at the gynecology and obstetrics clinic.
On the day of inclusion in the study, the patient will be collected blood from the ulnar vein - 5ml as part of a routine prenatal visit.
The following will be marked in the blood serum:
- concentration of minerals,
- placental capacity markers (pregnancy associated plasma protein A (PAPP-A), human chorionic gonadotropin (HCG), alfa-fetoprotein (AFP)).
The hair sample (about 0.5 g) from pregnant women will be taken on the day of inclusion in the study.
The pregnant women will be asked to complete a 3-day nutritional interview and nutritional survey.
From patients qualified for invasive prenatal diagnosis (amniocentesis), a sample of amniotic fluid (5 ml) will be taken, in which, in addition to the standardly evaluated parameters, selected mineral components will be marked.
Amniotic fluid samples will be collected during the routine amniocentesis procedure in patients with prenatal indications in 15-30 weeks of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A group of approximately 300 women is planned to be included in the study in the first trimester of pregnancy (up to 14 weeks of pregnancy).
Key inclusion criteria (5 listed)
- Diagnosed intrauterine pregnancy until week 14.
- Single pregnancy without congenital malformations in ultrasound examination.
- Lack of exponents threatening miscarriage (bleeding, lower abdominal pain, chorionic hematoma).
- Lack of use of drugs affecting the mineral metabolism of the body.
- Signing consent to participate in the study.
Key exclusion criteria (5 listed)
- Ectopic or heterotopic pregnancy.
- Twin pregnancy (or other multiple pregnancy).
- Obstetric load in the direction of numerous miscarriages, premature births under 34 weeks, pregnancy, fetal growth disorders (hypotrophy, macrosomia).
- Congenital and /or genetic defects found in current pregnancy or in the patient.
- Supply of drugs affecting the mineral metabolism of the body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
minerals (Ca, Mg, Fe, Zn)
Time frame: 1 year
measure minerals in serum, hair, amniotic fluid
8 secondary outcomes
maternal anthropometric parameters
Time frame: 2 years
fetal body weight
Time frame: 2 years
fetal head circumference
Time frame: 2 years
fetal biparietal diameter
Time frame: 2 years
prenatal diagnosis: PAPP-A
Time frame: 2 years
prenatal diagnosis: HCG
Time frame: 2 years
prenatal diagnosis: AFP
Time frame: 2 years
dietary intake
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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.
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 Pregnancy; Disorder, Blood, run by Poznan University of Life Sciences at 1 site in Poland.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Suliburska, Assoc. Prof. (+48 618487344, jsulibur@up.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minerals (Ca, Mg, Fe, Zn) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.