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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.
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:
Immediately after the childbirth following procedures will be done:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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 | at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress - thiobarbituric acid reactive substances (TBARS) | Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation. | at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |
| Matrix metalloproteinase 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Automatic oscillometric measurement of systolic and diastolic blood pressure (in mmHg) | at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |
| Heart rate | Automatic oscillometric measurement of heart rate (bpm) |
Inclusion Criteria:
Exclusion Criteria:
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healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Vulin, MD | Contact | +38531512300 | martina.vulin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ines Drenjancevic, MD, PhD | Faculty of Medicine Josip Juraj Strossmayer University of Osijek | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osijek University Hospital | Recruiting | Osijek | 31000 | Croatia |
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serum, placental tissue
ELISA measurement of serum matrix metalloproteinase 9 level in mother serum and placental tissue sample (taken after childbirth) |
| 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 | at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |
| Pregnancy outcome - duration | Duration of pregnancy (weeks and days) | 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) | at one time point immediately after childbirth |
| Pregnancy outcome - birth length | Birth length (in cm) | 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) | at one time point immediately after childbirth |
| at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |
| Body mass index | Measurement of BMI (kg/m2) | at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |
| Body composition | Body composition and body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) and Fat (Fat Mass kg). | at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |
| Body fluid status | Body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L). | at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) |