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临床试验/CTRI/2024/08/072516
CTRI/2024/08/072516招募中不适用

Incidence of pulmonary interstitial syndrome using point of care ultrasound in pregnant women with severe features of pre-eclampsia. A cohort study

Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
107
试验地点
1
主要终点
To observe the incidence of Pulmonary Interstitial Syndrome (PIS) using point of care ultrasound in pregnant women having pre-eclampsia with severe features

研究概览

简要总结

BACKGROUND: Acute pulmonary oedema (APE) isthe leading cause of respiratory failure in severe pre-eclamptic patients. The incidence of APE is reported to be 2.9%.and it contributes to significant maternal and neonatal morbidity and mortality. (1) Recently many studies have found that point of care  lung ultrasound (LUS) identifies pulmonary oedema earlier than Chest x ray. (2) Point-of-care ultrasound (POCUS) is being used increasingly in preeclampsia for diagnostic purposes. (3) Using lung ultrasound, studies detected pulmonary interstitial syndrome (PIS) in 25% of women presenting with preeclampsia with severe features. In a study by Ortner et al, they found the incidence  PIS of 24%,diastolic dysfunction of 33%,systolic dysfunction of 10%  and raised left ventricular end-diastolic pressure (LVEDP) of 20%in pre-eclampsia patients with severe features. (4) Since there are no studies in our population, we wanted to observe the incidence of PIS and its association with diastolic dysfunction in preeclampsia with severe features. Also, there are no studies which associated these POCUS findings with adverse maternal outcomes.

 RATIONALE:  Circulating angiogenic factors, decreased colloid oncotic pressure, diastolic dysfunction, and endothelial cell dysfunction, have been reported as factors that predispose preeclamptic women to pulmonary edema, a dangerous complication that further increases the risk of morbidity and mortality. Due to this, pre-eclamptic women are more prone to develop pulmonary interstitial syndrome (PIS) (radiological diagnosis of increased accumulation of fluid in the lung), a preclinical manifestation of pulmonary edema. Although previous studies have  reported the incidence and association of PIS with diastolic dysfunction, we would like to observe the incidence of PIS and its association with diastolic dysfunction in our population because of ethnic differences in the incidence and complications of pre- eclampsia with severe features.

 NOVELTY: There is lack of literature regarding the incidence of pulmonary interstitial syndrome and its association with diastolic dysfunction in pre-eclamptic patients with severe features in our population.

EXPECTED OUTCOME:  With the above knowledge, it will help us to find out the incidence and association of PIS with diastolic dysfunction in our population. This will help us to know the incidence of PIS and identify subset of population who has more tendency to develop adverse maternal outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant Women of aged more than 18 years
  • More than 34 weeks of gestation
  • Diagnosed case of severe pre-eclampsia as per ACOG (American College of Obstetrics and Gynaecology )guidelines.

排除标准

  • 1.Chronic pulmonary disease 2.Sepsis 3.Chronic renal failure 4.Chronic hepatic dyfunction.

结局指标

主要结局

To observe the incidence of Pulmonary Interstitial Syndrome (PIS) using point of care ultrasound in pregnant women having pre-eclampsia with severe features

时间窗: within 30 mins of admission

次要结局

  • 1.To determine the association between pulmonary interstitial syndrome with diastolic dysfunction(2.The correlation of serum albumin and NT-pro-BNP(N-terminal pro brain natriuretic peptide with pulmonary interstitial syndrome))

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Aswini Kuberan

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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