- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05048225
Dietary Salt During Pregnancy and Maternal Vascular Function
20 september 2021 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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
Studietyp
Observationell
Inskrivning (Förväntat)
80
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Martina Vulin, MD
- Telefonnummer: +38531512300
- E-post: martina.vulin@gmail.com
Studieorter
-
-
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Osijek, Kroatien, 31000
- Rekrytering
- Osijek University Hospital
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Kontakt:
- Martina Vulin, MD
- Telefonnummer: +385 31 512 300
- E-post: martina.vulin@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Maternal systemic microvascular function
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Tidsram: 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.
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Matrix metalloproteinase 9
Tidsram: 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
Tidsram: 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
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Pregnancy outcome - duration
Tidsram: 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
Tidsram: at one time point immediately after childbirth
|
Birth weight (in grams)
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at one time point immediately after childbirth
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Pregnancy outcome - birth length
Tidsram: at one time point immediately after childbirth
|
Birth length (in cm)
|
at one time point immediately after childbirth
|
Pregnancy outcome - Apgar score
Tidsram: 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)
|
at one time point immediately after childbirth
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Measurement of BMI (kg/m2)
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
Body composition
Tidsram: 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
Tidsram: 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).
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Ines Drenjancevic, MD, PhD, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2021
Primärt slutförande (Förväntat)
31 december 2022
Avslutad studie (Förväntat)
31 december 2023
Studieregistreringsdatum
Först inskickad
8 juni 2021
Först inskickad som uppfyllde QC-kriterierna
8 september 2021
Första postat (Faktisk)
17 september 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 september 2021
Senast verifierad
1 september 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 602-04/21-08/07
Plan för individuella deltagardata (IPD)
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NEJ
Läkemedels- och apparatinformation, studiedokument
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