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临床试验/CTRI/2019/01/016890
CTRI/2019/01/016890尚未招募不适用

Comparison and correlation of serum and placental levels of angiotensin-converting enzyme (ACE) and nitric oxide (NO) in preeclampsia

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2019年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
124
试验地点
1
主要终点
Difference in levels of serum and placental angiotensin-converting enzyme (ACE) and nitric oxide (NO) between case and control groups

研究概览

简要总结

Preeclampsia (PE) is a pregnancy-exclusive multi-system disorder complicating 5-7% of pregnancies and is one of the leading causes of feto-maternal morbidity and mortality worldwide. It is characterized as hypertension (>140/90mm Hg) after 20 weeks’ gestation, accompanied by proteinuria (>300 mg/l). Without sufficient changes in the uterine vasculature in early pregnancy, the placenta may become hypoxic with advancing gestation and suffer from oxygen deficiency at the tissue levels, and the supply of both nutrients and oxygen to the fetus is disturbed. Altered renin-angiotensin-aldosterone pathway metabolites- including angiotensin-converting enzyme (ACE) - generated within placental tissue, contribute to increased vasoconstriction, increase in tissue hypoxia and consequent lipid peroxidation seen in preeclampsia. This, in turn, could lead to a decrease in nitric oxide (NO) levels in the placental tissue, causing further vasoconstriction.

A similar mechanism, if occurring in the maternal circulation as well, could further explain the systemic vascular dysfunction observed in this condition. The aim of this study is to estimate the placental levels of ACE and NO, and serum levels of ACE and NO and compare them with an aim to elucidate the pathophysiology of preeclampsia.

The study will be carriedout in the Department of Biochemistry, KMC, MAHE. Ethicalclearance was obtained from the Institutional Ethical Committee (IEC), following which 124 leftover bloodsamples will be collected after obtaining consent from subjects. Placentaltissue samples will be collected from the same subjects following delivery. ACEwill be measured in the serum and placental tissue homogenate usingHippuryl-Histidyl-Leucine (HHL) as substrate by a method modified from Cushmanand Cheung. NO will be estimated in serum and placental homogenate using Griessreagent.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Cases: Patients diagnosed with preeclampsia who are in their 3rd trimester of pregnancy Controls: Healthy subjects in the 3rd trimester of pregnancy who do not exhibit symptoms of preeclampsia and gestational diabetes.

排除标准

  • Pregnant subjects showing complications such as gestational diabetes, hypertension, etc are excluded.

结局指标

主要结局

Difference in levels of serum and placental angiotensin-converting enzyme (ACE) and nitric oxide (NO) between case and control groups

时间窗: Samples are collected in 3rd trimester of pregnancy

次要结局

  • Correlation between serum ACE and NO(Correlation between placental ACE and NO)

研究者

申办方类型
Private medical college

研究点 (1)

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