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CTRI Number  CTRI/2024/08/072929 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational comparative 
Study Design  Other 
Public Title of Study   Study comparing observed caeserean section in robsons classification with WHO C section model . 
Scientific Title of Study   Study comparing observed caeserean section in robsons classification with WHO C section model . 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPravallika Gayathri Gummadi 
Designation  Junior resident. 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of obstetrics and gynaecolgy,kasturba hospital,Manipal,Udupi,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9573237954  
Fax    
Email  pravallika.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayaraman Nambiar 
Designation  Professor and head of unit 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of obstetrics and gynaecolgy,kasturba hospital,Manipal,Udupi,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845082923  
Fax    
Email  drram.nambiar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jayaraman Nambiar 
Designation  Professor and head of unit 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of obstetrics and gynaecolgy,kasturba hospital,Manipal,Udupi,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845082923  
Fax    
Email  drram.nambiar@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba medical college, Manipal, Udupi, karnataka, 576104 
 
Primary Sponsor  
Name  Dr Pravallika Gayathri Gummadi 
Address  Department of obstetrics and gynaecology ,kasturba hospital manipal, udupi, karnataka 576104 
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 
Pravallika Gayathri Gummadi  Kasturba hospital,manipal,Udupi  Department of obstetrics and gynaecology,kasturba hospital,manipal,Udupi,Karnataka 576104
Udupi
KARNATAKA 		 9573237954

pravallika.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80-O82||Encounter for delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Pregnant mothers with varying parity (nulliparous/multiparous) who deliver in KMC,
Manipal.
2. Cases where complete data for the Robson classification and the WHO cesarean
section model criteria are available. 
 
ExclusionCriteria 
Details  1. Pregnant individuals with incomplete or missing data on the mode of delivery.
2. Cases lacking information required for the application of the Robson classification or the WHO
cesarean section model.
3. Deliveries with ambiguous or unclear indications for cesarean section.
4. Cases involving multiple pregnancies (e.g., twins or triplets) unless data can be appropriately
stratified.
5. Deliveries occurring outside the predefined study period.
6. Pregnancies with documented contraindications for vaginal delivery, impacting the application
of the classification systems. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Compare the rates of caesarean sections determined by WHO’s model and
Robson’s criteria in a given population. 		 over 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the rates of caesarean sections determined by WHO’s model and
Robson’s criteria in a given population. 		 Usage of WHO’s model and
Robson’s criteria 
 
Target Sample Size   Total Sample Size="683"
Sample Size from India="683" 
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)   01/09/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Understanding the accuracy of caesarean section rate classifications is crucial for optimizing delivery practices and, consequently, improving maternal health outcomes. Comparing observed caesarean section rates in Robson’s classification with the WHO C-section model is valuable for several reasons. Robson’s classification provides a comprehensive framework for categorizing cesarean deliveries, considering multiple factors such as parity, previous cesareans, gestational age, and fetal presentation. Although The Robson classification is widely accepted, but its limitations may affect its applicability. By comparing it with the WHO Cesarean Section Model, this study aims to identify areas for improvement and enhance the precision of classification systems. Furthermore understanding the reasons behind cesarean section variations in different classifications aids in determining specific areas where interventions may be needed. It helps healthcare providers to tailor strategies to reduce unnecessary cesareans, promoting optimal maternal and neonatal outcomes. In brief, comparing cesarean section rates in Robson’s classification with the WHO C-section model provides a detailed understanding of delivery practices, facilitating targeted interventions, and contributing to the development of standardized guidelines for optimal maternal and neonatal care. 
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