Dietary Salt During Pregnancy and Maternal Vascular Function
2021년 9월 20일 업데이트: 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.
연구 개요
상세 설명
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
연구 유형
관찰
등록 (예상)
80
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Martina Vulin, MD
- 전화번호: +38531512300
- 이메일: martina.vulin@gmail.com
연구 장소
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Osijek, 크로아티아, 31000
- 모병
- Osijek University Hospital
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연락하다:
- Martina Vulin, MD
- 전화번호: +385 31 512 300
- 이메일: martina.vulin@gmail.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
샘플링 방법
확률 샘플
연구 인구
healthy pregnant women in the third trimester of pregnancy (37-38 weeks of pregnancy)
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maternal systemic microvascular function
기간: 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
기간: 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
기간: 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
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at one time point in the third trimester of pregnancy (37-38 weeks of pregnancy)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Blood pressure
기간: 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
기간: 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
기간: 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)
|
|
Body composition
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Ines Drenjančević, MD, PhD, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 9월 1일
기본 완료 (예상)
2022년 12월 31일
연구 완료 (예상)
2023년 12월 31일
연구 등록 날짜
최초 제출
2021년 6월 8일
QC 기준을 충족하는 최초 제출
2021년 9월 8일
처음 게시됨 (실제)
2021년 9월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 20일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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