| CTRI Number |
CTRI/2024/03/063871 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Insights into Maternal Near Miss: A Critical Analysis of Healthcare Quality for Informed Public Health Action" |
|
Scientific Title of Study
|
Determinants of Maternal near miss as an indicator of Quality health care in transforming health data to actionable information Analytical 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 |
Bharathi R |
| Designation |
Research Scholar |
| Affiliation |
KLE Academy of higher education and research JN Medical college |
| Address |
Department of Hospital Administration, Room Number 19,2nd Floor, KLE Academy of Higher Education and Research, Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7022711274 |
| Fax |
|
| Email |
bharthir188@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anil Hogade |
| Designation |
Professor |
| Affiliation |
KLE Academy of higher education and research JN Medical college |
| Address |
Department of Hospital Administration, Room Number 19,2nd Floor, KLE Academy of Higher Education and Research, Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9480397727 |
| Fax |
|
| Email |
hogadeanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharathi R |
| Designation |
Research Scholar |
| Affiliation |
KLE Academy of higher education and research JN Medical college |
| Address |
Department of Hospital Administration, Room Number 19,2nd Floor, KLE Academy of Higher Education and Research, Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7022711274 |
| Fax |
|
| Email |
bharthir188@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar Belagavi -590010 |
|
|
Primary Sponsor
|
| Name |
Bharathi R |
| Address |
Department of Hospital Administration, Room Number 19,2nd Floor, KLE Academy of Higher Education and Research, Nehru Nagar Belagavi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KLE s Dr Prabhakar Kore Hospital andMRCNehrunagar Belagavi |
KLE s Dr. Prabhakar Kore Hospital and MRC Nehrunagar Belagavi |
| 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 Hema S Patil |
KLE s Dr.Prabhakar Kore Hospital and MRC |
Department of OBG
number 10 ,G+1 floor ,
KLEs Dr. Prabhakar Kore Hospital and MRC,Nehrunagar ,Belagavi-590010
Belgaum
KARNATAKA |
9164342888
hemabanad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH Ethics Committee on Human Subjects for Ph.D. Research Project |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with potentially life-threatening conditions, Maternal near miss, maternal deaths.
WHO maternal near miss criteria
Ministry of health and family welfare India Operational guideline 2014 |
|
| ExclusionCriteria |
| Details |
Pregnant women do not meet WHO maternal near miss criteria and
Ministry of health and family welfare India Operational guideline 2014 |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effective management of complications related to pregnancy and childbirth is matching the level of standard care to the severity of clinical conditions. Maternal near miss Determinants, Incidence and Mortality index of Maternal near miss |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| measurement of standard quality of care, Health management information in the facility,Hospital access indicators and Intra hospital care,process indicators related to Severe maternal outcomes |
1year |
|
|
Target Sample Size
|
Total Sample Size="3377"
Sample Size from India="3377"
Final Enrollment numbers achieved (Total)= "310"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
29/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bharthir188@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study is a Hospital Cross-sectional study measuring the determinants and factors associated with potentially life-threatening conditions during Pregnancy, childbirth and postpartum up to 42 days of termination of pregnancy including accidental and incidental causes. The incidence of Maternal near misses and indices are calculated to know the quality of care. Maternal severity index model to know the severity of indicators are measured. The probability of maternal death among the survivors would help to know the morbidity burden on the health care system for better policy implementation and accountability of maternal morbidity would yield valuable information for gap identification and correction in the health system. The study duration will be 1 year measuring annual incidents maternal near miss with maternal and neonatal outcomes associated with severe maternal morbidities. study will be conducted in a tertiary care hospital |