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临床试验/CTRI/2025/03/081606
CTRI/2025/03/081606尚未招募不适用

Comparison of Modified Obstetric Early Warning Score (MOEWS) and Quick Sequential Organ Failure Assessment for Pregnancy (qSOFA-P) Score for prognostication of critically ill obstetric patients admitted to Intensive care unit in a tertiary care hospital in Northern India: A Prospective observational study

Dr Navneh Samagh1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2025年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
222
试验地点
1
主要终点
To evaluate MOEWS and qSOFA-P scores for predicting obstetric mortality which is death during pregnancy post 20 weeks of POG till 6 weeks after delivery

研究概览

简要总结

Pregnancy is associated with many physiological changes involving the cardiovascular, respiratory, renal, and haematological system; thus, interpretation of these scores is more challenging in the obstetric population. It has been seen that the use of these scores in obstetric patients often overpredicts mortality. Overestimation of mortality risk by these scores in obstetric patients likely relates to pregnancy-related physiological changes that are not included in mortality scores, demographic characteristics, and lack of comorbidities in this population, and the significant and unique improvement in mortality that follows specific interventions in pregnancy.

No national or international ‘Gold standard’ obstetric early warning scoring system exists. Maternal Early Obstetric Warning System (MEOWS) chart adopted from CEMACH 2003– 2005 report is based on the principle that abnormalities in physiological parameters precede critical illness. The ‘track and trigger’ of physiological parameters on this chart can aid in recognition of maternal morbidity at an early stage, ultimately halting the cascade of severe maternal morbidity and mortality.  The major advantage of this score is that it uses the triggers according to the physiological changes of pregnant women. Secondly, since the score is based only on clinical parameters and no laboratory values are required, it is easy to calculate and less time-consuming.11,12Pregnancy-specific modifications or "qSOFA-P" (respiratory rate [RR] ≥ 35 breaths/minute and systolic blood pressure [SBP] ≤ 85 mm Hg)  has been found to significantly improve prediction of severe maternal morbidity (AUC = 0.77, p < 0.001, sensitivity = 0.79, and specificity = 0.74).13 The aim of this study is to evaluate accuracy of MOEWS and qSOFA-P to predict mortality for obstetric patients admitted to ICU in a tertiary care hospital of North India.

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

  • All consecutive pregnant women with the period of gestation of more than 20 weeks or women admitted within 6 weeks after delivery.

排除标准

  • Pregnant women with period of gestation less than 20 weeks and refusal of consent.

结局指标

主要结局

To evaluate MOEWS and qSOFA-P scores for predicting obstetric mortality which is death during pregnancy post 20 weeks of POG till 6 weeks after delivery

时间窗: From admission into ICU to discharge from ICU

次要结局

  • To evaluate MOEWS and qSOFA-P scores for predicting obstetric morbidity in terms of length of ICU stay, number of days on mechanical ventilation and vasopressor requirement(From admission into ICU to discharge from ICU)

研究者

发起方
Dr Navneh Samagh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Navneh Samagh

AIIMS Bathinda

研究点 (1)

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