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CTRI Number  CTRI/2025/03/081606 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparing the Modified Obstetric Early Warning Score (MOEWS) and Quick Sequential Organ Failure Assessment Score for Pregnancy(qSOFA-P) as a tool in prognosticating critically ill obstetric patients admitted to Intensive care unit in a tertiary care hospital:A Prospective observational study 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Navneh Samagh 
Designation  Associate professor 
Affiliation  AIIMS Bathinda 
Address  Room no 139, Department of Anaesthesiology and critical care, All India Institute of Medical Sciences, Mandi dabwali road, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8427264480  
Fax    
Email  navnehsamagh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navneh Samagh 
Designation  Associate professor 
Affiliation  AIIMS Bathinda 
Address  Room no 139, Department of Anaesthesiology and critical care, All India Institute of Medical Sciences, Mandi dabwali road, Bathinda


PUNJAB
151001
India 
Phone  8427264480  
Fax    
Email  navnehsamagh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Navneh Samagh 
Designation  Associate professor 
Affiliation  AIIMS Bathinda 
Address  Room no 139, Department of Anaesthesiology and critical care, All India Institute of Medical Sciences, Mandi dabwali road, Bathinda


PUNJAB
151001
India 
Phone  8427264480  
Fax    
Email  navnehsamagh@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda 
 
Primary Sponsor  
Name  Dr Navneh Samagh 
Address  Room no 139 Department of Anaesthesiology and critical care All India Institute of Medical Sciences, Bathinda Mandi dabwali road, Bathinda , Punjab-151001 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navneh Samagh  All India Institute of Medical sciences, Bathinda  Department of Anaesthesiology and critical care, All India Institute of Medical sciences, Mandi dabwali road, Bathinda
Bathinda
PUNJAB 
8427264480

navnehsamagh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Bathinda Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All consecutive pregnant women with the period of gestation of more than 20 weeks or women admitted within 6 weeks after delivery 
 
ExclusionCriteria 
Details  Pregnant women with period of gestation less than 20 weeks and refusal of consent 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
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  From admission into ICU to discharge from ICU 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="222"
Sample Size from India="222" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.11,12 Pregnancy-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.

 
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