Dietary Salt During Pregnancy and Maternal Vascular Function
20 septembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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
Type d'étude
Observationnel
Inscription (Anticipé)
80
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Martina Vulin, MD
- Numéro de téléphone: +38531512300
- E-mail: martina.vulin@gmail.com
Lieux d'étude
-
-
-
Osijek, Croatie, 31000
- Recrutement
- Osijek University Hospital
-
Contact:
- Martina Vulin, MD
- Numéro de téléphone: +385 31 512 300
- E-mail: martina.vulin@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maternal systemic microvascular function
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Délai: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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
Délai: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy) (serum) and immediately after childbirth (placental tissue sample)
|
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
Délai: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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
Délai: the outcome measure will be assessed at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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
Délai: at one time point immediately after childbirth
|
Birth weight (in grams)
|
at one time point immediately after childbirth
|
|
Pregnancy outcome - birth length
Délai: at one time point immediately after childbirth
|
Birth length (in cm)
|
at one time point immediately after childbirth
|
|
Pregnancy outcome - Apgar score
Délai: at one time point immediately after childbirth
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood pressure
Délai: 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)
|
|
Heart rate
Délai: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Automatic oscillometric measurement of heart rate (bpm)
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Body mass index
Délai: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Measurement of BMI (kg/m2)
|
at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
|
Body composition
Délai: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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
Délai: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: Ines Drenjančević, MD, PhD, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2021
Achèvement primaire (Anticipé)
31 décembre 2022
Achèvement de l'étude (Anticipé)
31 décembre 2023
Dates d'inscription aux études
Première soumission
8 juin 2021
Première soumission répondant aux critères de contrôle qualité
8 septembre 2021
Première publication (Réel)
17 septembre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 septembre 2021
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 602-04/21-08/07
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .