Salt; ExcessNCT05048225
Dietary Salt During Pregnancy and Maternal Vascular Function
An observational study of Salt; Excess and Pregnancy Related, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
The main goal of this study is to investigate the association of dietary salt intake during pregnancy with systemic micro- and macrovascular reactivity and uteroplacental vascular function of the mother, and to examine the potential impact of elevated oxidative stress on this association. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Salt; Excess, Pregnancy Related
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2021to 31 Dec 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Who may be able to join
- healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Who cannot join
- smoking
- prenatal hypertension
- thrombophilia
- low molecular weight heparin use
- coronary heart disease
- preconception diabetes
Show all 10Show fewer
- gestational diabetes
- renal impairment
- cerebrovascular and peripheral artery disease
- any other preconception disease that could affect vascular and endothelial function
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Osijek University Hospital
Osijek, 31000
Martina Vulin, MD, +385 31 512 300, martina.vulin@gmail.com
About this study
Official title: Influence of Dietary Salt Intake During Pregnancy on Maternal Systemic and Uteroplacental Vascular Function
The main goal of this study is to investigate the association of dietary salt intake during pregnancy with systemic micro- and macrovascular reactivity and uteroplacental vascular function of the mother, and to examine the potential impact of elevated oxidative stress on this association. Also, the aim is to investigate whether there is an association between excessive salt intake during pregnancy and the outcome of pregnancy.
Read the detailed description
During the study pregnant women at the third trimester of pregnancy (37-38 weeks of pregnancy) will have one study visit during which following procedures will be done:
- measurement of maternal systemic microvascular function by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside)
- measurement of maternal systemic macrovascular function by vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
- measurement of maternal uteroplacental function by ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
- venous blood sampling; serum will be stored for measurement of oxidative stress, matrix metalloproteinase 9 and endocan level
- 24-hour urine natriuresis (to estimate daily salt intake)
- measurement of blood pressure, heart rate, height and weight, body composition
Immediately after the childbirth following procedures will be done:
- assessment of pregnancy outcome (duration of pregnancy, child birth weight, child birth length and Apgar score)
- placental tissue will be taken and stored for measurement of matrix metalloproteinase 9
- Conditions
- Salt; Excess, Pregnancy Related
- Keywords
- salt intake, microcirculation, macrocirculation, endothelium, uteroplacental function, pregnancy, oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low-salt (LS) group | intake of < 5 g of salt per day | |
| Normal-salt (NS) group | intake of 5 - 7.5 g of salt per day | |
| High-salt (HS) group | intake of 7.5 - 10 g of salt per day | |
| Very high-salt (VHS) group | intake of > 10 g of salt per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal systemic microvascular function
Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
Measured: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Maternal systemic macrovascular function
Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
Measured: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Maternal uteroplacental function
Ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
Measured: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Secondary outcomes (7)
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.
Measured: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Matrix metalloproteinase 9
ELISA measurement of serum matrix metalloproteinase 9 level in mother serum and placental tissue sample (taken after childbirth)
Measured: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
Endocan
ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation
Measured: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Pregnancy outcome - duration
Duration of pregnancy (weeks and days)
Measured: the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Pregnancy outcome - birth weight
Birth weight (in grams)
Measured: at one time point immediately after childbirth
Pregnancy outcome - birth length
Birth length (in cm)
Measured: at one time point immediately after childbirth
Pregnancy outcome - Apgar score
Apgar score (in Apgar score scale, a total score of 1 to 10; the higher the score, the better the baby is doing after birth)
Measured: at one time point immediately after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt; ExcessStudies 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Drenjancevic, MD, PhD, Study chair, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048225
- Sponsor's protocol ID
- 602-04/21-08/07
- Status last verified
- Sep 2021
- First submitted
- 8 Jun 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dietary Salt Intake During Pregnancy on Maternal Systemic and Uteroplacental Vascular Function
- ClinicalTrials.gov ID
- NCT05048225
- Acronym / sponsor ID
- 602-04/21-08/07
- Conditions
- Salt; Excess, Pregnancy Related
- Keywords
- salt intake, microcirculation, macrocirculation, endothelium, uteroplacental function, pregnancy, oxidative stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Sep 2021 (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.
The main goal of this study is to investigate the association of dietary salt intake during pregnancy with systemic micro- and macrovascular reactivity and uteroplacental vascular function of the mother, and to examine the potential impact of elevated oxidative stress on this association. Also, the aim is to investigate whether there is an association between excessive salt intake during pregnancy and the outcome of pregnancy.
Detailed description
During the study pregnant women at the third trimester of pregnancy (37-38 weeks of pregnancy) will have one study visit during which following procedures will be done:
- measurement of maternal systemic microvascular function by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside)
- measurement of maternal systemic macrovascular function by vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
- measurement of maternal uteroplacental function by ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
- venous blood sampling; serum will be stored for measurement of oxidative stress, matrix metalloproteinase 9 and endocan level
- 24-hour urine natriuresis (to estimate daily salt intake)
- measurement of blood pressure, heart rate, height and weight, body composition
Immediately after the childbirth following procedures will be done:
- assessment of pregnancy outcome (duration of pregnancy, child birth weight, child birth length and Apgar score)
- placental tissue will be taken and stored for measurement of matrix metalloproteinase 9
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-salt (LS) group | – | –intake of < 5 g of salt per day |
| Normal-salt (NS) group | – | –intake of 5 - 7.5 g of salt per day |
| High-salt (HS) group | – | –intake of 7.5 - 10 g of salt per day |
| Very high-salt (VHS) group | – | –intake of > 10 g of salt per day |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Key inclusion criteria (1 listed)
- healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Key exclusion criteria (10 listed)
- smoking
- prenatal hypertension
- thrombophilia
- low molecular weight heparin use
- coronary heart disease
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
Maternal systemic microvascular function
Time frame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
Maternal systemic macrovascular function
Time frame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
Maternal uteroplacental function
Time frame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
7 secondary outcomes
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Time frame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Matrix metalloproteinase 9
Time frame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
Endocan
Time frame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Pregnancy outcome - duration
Time frame: the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
Pregnancy outcome - birth weight
Time frame: at one time point immediately after childbirth
Pregnancy outcome - birth length
Time frame: at one time point immediately after childbirth
Pregnancy outcome - Apgar score
Time frame: at one time point immediately after childbirth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- 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.
Ines Drenjancevic, MD, PhD study chair
Faculty of Medicine Josip Juraj Strossmayer University of Osijek
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 Salt; Excess and Pregnancy Related, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
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 1 inclusion and 10 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 27 Sep 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 Croatia. 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?
Contact Martina Vulin, MD (+38531512300, martina.vulin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal systemic microvascular function (time frame: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)). The study lists 3 primary outcomes in all. 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 Sep 2021.