| 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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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" |
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Phase of Trial
|
N/A |
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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
|
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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. |