跳至主要内容
临床试验/CTRI/2024/12/077771
CTRI/2024/12/077771招募中不适用

Assessment of markers of Preeclampsia after delivery and correlation with future risk factors of Cardio vascular disease in women

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2024年12月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
1
主要终点
1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life.

研究概览

简要总结

Hypertensive disorders of pregnancy (HDP) including preeclampsia occur in almost 10% of gestations. These women are known to have higher cardiovascular morbidity and mortality later in life in comparison with parous controls that had normotensive pregnancies. The pathophysiologic mechanisms linking preeclampsia (PE) and gestational hypertension (GH) to maternal CVD later in life are not well understood; however, several hypotheses have been proposed. Studies during pregnancy reported that the newly identified stage 1 hypertension in pregnancy was associated with increased risk of preeclampsia compared with normotensive women (39% versus 15%) (27). The United Nations Sustainable Development Goal (SDG) 3: Good health and Wellbeing aims to ensure healthy lives and promote well-being for all at all ages (3). Studies have shown that women with PE have a 12-fold increase in having a cardiovascular event. A meta-analysis demonstrated a 4.2-fold increased risk of heart failure, a 2.5-fold increased risk of coronary artery disease, and a 1.8-fold increased risk of stroke in women with preeclamptic pregnancies over a follow up period of up to 39 years (25,31). A possibility is that HDP and subsequent CVD share common predisposing risk factors and are both manifestations of the same pathophysiologic processes at different times in a woman’s life.  Pregnant women after delivery go back to society and only come back in contact with health care system once she develops hypertension or any cardiovascular event. Thus a very critical window period is lost where in modification of risk factors or prevention of complications can be as taken. There are various biomarkers which are used to predict severity of preeclampsia during antenatal period however very limited data is available after delivery in these women. Biomarkers and inflammatory markers sFlt, NLR, PLR, hCRP and ETCO is higher associated with the development and severity of preeclampsia so we aim to evaluate correlate noninvasive, inflammatory marker and biomarkers after delivery and correlate at risk of developing hypertension a precursor of CVD later in life.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Women over 18 years of age.
  • Diagnosed with hypertension during pregnancy (preeclampsia and gestational hypertension).

排除标准

  • History of chronic kidney disease, heart disease, diabetes with renal involvement or vasculopathy.
  • Pregnancy with chronic hypertension, other pre-existing medical conditions or history of illicit drug use.
  • Intervention that could modify the outcome like aspirin use.

结局指标

主要结局

1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life.

时间窗: 1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life. | 2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker | 3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women. | 4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life. | 5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life

2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker

时间窗: 1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life. | 2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker | 3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women. | 4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life. | 5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life

3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women.

时间窗: 1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life. | 2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker | 3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women. | 4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life. | 5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life

4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life.

时间窗: 1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life. | 2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker | 3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women. | 4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life. | 5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life

5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life

时间窗: 1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life. | 2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker | 3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women. | 4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life. | 5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life

次要结局

  • 1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life.(2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Garima Kachhawa

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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