Dietary Salt During Pregnancy and Maternal Vascular Function
2021年9月20日 更新者：Ines Drenjancevic、Josip Juraj Strossmayer University of Osijek
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.
研究概览
详细说明
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
研究类型
观察性的
注册 (预期的)
80
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Martina Vulin, MD
- 电话号码：+38531512300
- 邮箱：martina.vulin@gmail.com
学习地点
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Osijek、克罗地亚、31000
- 招聘中
- Osijek University Hospital
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接触：
- Martina Vulin, MD
- 电话号码：+385 31 512 300
- 邮箱：martina.vulin@gmail.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
概率样本
研究人群
healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
描述
Inclusion Criteria:
- healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Exclusion Criteria:
- smoking
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Low-salt (LS) group
intake of < 5 g of salt per day
|
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Normal-salt (NS) group
intake of 5 - 7.5 g of salt per day
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High-salt (HS) group
intake of 7.5 - 10 g of salt per day
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Very high-salt (VHS) group
intake of > 10 g of salt per day
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maternal systemic microvascular function
大体时间：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)
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Maternal systemic macrovascular function
大体时间：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)
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Maternal uteroplacental function
大体时间：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
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Measurement of biomarkers of oxidative stress level.
Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Matrix metalloproteinase 9
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
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ELISA measurement of serum matrix metalloproteinase 9 level in mother serum and placental tissue sample (taken after childbirth)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
|
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Endocan
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Pregnancy outcome - duration
大体时间：the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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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
大体时间：at one time point immediately after childbirth
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Birth weight (in grams)
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at one time point immediately after childbirth
|
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Pregnancy outcome - birth length
大体时间：at one time point immediately after childbirth
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Birth length (in cm)
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at one time point immediately after childbirth
|
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Pregnancy outcome - Apgar score
大体时间：at one time point immediately after childbirth
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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)
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at one time point immediately after childbirth
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood pressure
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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)
|
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Heart rate
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Automatic oscillometric measurement of heart rate (bpm)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Body mass index
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Measurement of BMI (kg/m2)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Body composition
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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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).
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Body fluid status
大体时间：at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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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)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Ines Drenjančević, MD, PhD、Faculty of Medicine Josip Juraj Strossmayer University of Osijek
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年9月1日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2023年12月31日
研究注册日期
首次提交
2021年6月8日
首先提交符合 QC 标准的
2021年9月8日
首次发布 (实际的)
2021年9月17日
研究记录更新
最后更新发布 (实际的)
2021年9月27日
上次提交的符合 QC 标准的更新
2021年9月20日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.