Influence of Dietary Salt Intake During Pregnancy on Maternal Systemic and Uteroplacental Vascular Function
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Maternal uteroplacental function
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Exclusion Criteria
- •prenatal hypertension
- •thrombophilia
- •low molecular weight heparin use
- •coronary heart disease
- •preconception diabetes
- •gestational diabetes
- •renal impairment
- •cerebrovascular and peripheral artery disease
- •any other preconception disease that could affect vascular and endothelial function
Outcomes
Primary Outcomes
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
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)
Secondary Outcomes
- Pregnancy outcome - birth length(at one time point immediately after childbirth)
- Pregnancy outcome - Apgar score(at one time point immediately after childbirth)
- Endocan(at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy))
- Pregnancy outcome - duration(the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy))
- Oxidative stress - thiobarbituric acid reactive substances (TBARS)(at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy))
- Matrix metalloproteinase 9(at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample))
- Pregnancy outcome - birth weight(at one time point immediately after childbirth)
Investigators
Ines Drenjancevic
Head of Department of Physiology and Immunology Faculty of Medicine Osijek
Josip Juraj Strossmayer University of Osijek