Dietary Salt During Pregnancy and Maternal Vascular Function
20 de septiembre de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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
Tipo de estudio
De observación
Inscripción (Anticipado)
80
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Martina Vulin, MD
- Número de teléfono: +38531512300
- Correo electrónico: martina.vulin@gmail.com
Ubicaciones de estudio
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Osijek, Croacia, 31000
- Reclutamiento
- Osijek University Hospital
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Contacto:
- Martina Vulin, MD
- Número de teléfono: +385 31 512 300
- Correo electrónico: martina.vulin@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra de probabilidad
Población de estudio
healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maternal systemic microvascular function
Periodo de tiempo: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Maternal systemic macrovascular function
Periodo de tiempo: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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Maternal uteroplacental function
Periodo de tiempo: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Ultrasound color Doppler measurement of umbilical artery and fetal middle cerebral artery blood flow
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
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Pregnancy outcome - duration
Periodo de tiempo: 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)
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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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Pregnancy outcome - birth weight
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood pressure
Periodo de tiempo: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Automatic oscillometric measurement of systolic and diastolic blood pressure (in mmHg)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Heart rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Ines Drenjančević, MD, PhD, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2021
Finalización primaria (Anticipado)
31 de diciembre de 2022
Finalización del estudio (Anticipado)
31 de diciembre de 2023
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2021
Publicado por primera vez (Actual)
17 de septiembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
20 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 602-04/21-08/07
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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