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CTRI Number  CTRI/2024/03/064849 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Cesarean section for Labor related indications.  
Scientific Title of Study   Labor Related Indications as determinant for primary cesarean deliveries in various Robson groups.  
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 Divya Pandey 
Designation  Professor 
Affiliation  Safdarjung hospital,Delhi 
Address  Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung hospital, MG road

South
DELHI
110029
India 
Phone  8860198440  
Fax    
Email  dr_devya1@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr K Manasa Devi 
Designation  Post graduate student 
Affiliation  VMMC and Safdarjung hospital, delhi 
Address  Department of obstetrics and Gynaecology Vardhman mahavir Medical College and Safdarjung hospital, Delhi

South
DELHI
110029
India 
Phone  918309301611  
Fax    
Email  manasamaami@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Manasa Devi 
Designation  Post graduate student 
Affiliation  VMMC and Safdarjung hospital, delhi 
Address  Department of obstetrics and Gynaecology Vardhman mahavir Medical College and Safdarjung hospital, Delhi


DELHI
110029
India 
Phone  918309301611  
Fax    
Email  manasamaami@gmail.com  
 
Source of Monetary or Material Support  
Safdarjung Hospital 
 
Primary Sponsor  
Name  VMMC AND Safdarjung Hospital 
Address  MG Road, Delhi-110029, India 
Type of Sponsor  Government medical college 
 
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 Divya Pandey  Safdarjung Hospital, Delhi  Department of Obstetrics And Gynecology,Vardhman Mahavir Medical College and Safdarjung Hospital
South
DELHI 		 8860198440

dr_devya1@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, VMMC and Safdarjung Hospital, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O629||Abnormality of forces of labor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All antenatal women in third trimester 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of women with labor related indications undergoing primary cesarean delivery in Robson groups.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
None  Not applicable 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   03/04/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   AIM:
To evaluate labour related indications as determinant of primary caesarean delivery in various
Robson groups.
OBJECTIVE:
To evaluate labour related indications as determinant of primary caesarean delivery in various Robson
groups.
VENUE OF STUDY: Department of Obstetrics & Gynaecology, VMMC & Safdarjung Hospital,
New Delhi.
TYPE OF STUDY: Prospective observational Study
DURATION OF STUDY: 18 months
The study will be conducted in Department of Obstetrics & Gynaecology, VMMC & Safdarjung
Hospital, New Delhi.
METHODOLOGY: This prospective observational study will be done on 300 antenatal women without
prior cesarean delivery. Antenatal women admitted for delivery in the department of OBGYN, SJH will be
assigned a Robson group based on Robson ten group classification system which is further based on five
obstetric parameters viz parity, onset of labor, gestational age, presentation and number of fetuses. This
classification is as follows
Group Description
1 Nullipara, single, cephalic, term pregnancy, spontaneous labour
2 Nullipara, single, cephalic, term, induced labour or planned CS
3 Multipara without uterine scar, single, cephalic, term, spontaneous
labour
4 Multipara without uterine scar, single, cephalic, term, induced
labour or planned CS
5 Multipara with uterine scar, single, cephalic, term
6 Nullipara, single, Breech presentation
7 Multipara, single, breech, including previous C-Section
8 Multiple Pregnancy
9 Single, abnormal lie, including previous scar
10 Single, Cephalic, Preterm including previous scar
These women will be followed by monitoring progress of labor and fetal heart rate as per
departmental protocol. The women in various Robson groups undergoing primary cesarean
delivery will be followed. The number of women undergoing primary cesarean delivery for both
labor and non-labor related indications will be noted. The labor related indications will comprise
of protracted labor, arrest of labor, second stage arrest.
 Basic clinic-demographic parameters like age, obstetric history, gravidity, parity, details of labor
 will be recorded on a preformed proforma. These women will be followed for feto-maternal
 outcomes as follows.
The maternal parameters that will be noted are stage of labor, period of gestation, presence of
comorbidity, immediate cause of caesarean section, intra-operative complication like PPH/Trauma,
need for blood transfusion, need of HDU/ICU stay, need of life support system ultimate final outcome
(discharged / death).
The fetal parameters that will be noted are birth weight, APGAR Score at 5 min, NICU stay, ultimate
neonatal outcome (discharged / death).
The number of women in various Robson groups who will be delivered vaginally will also be noted.
The data will be entered into excel sheet and will be subjected to statistical analysis
Outcome
Number of women with labor related indications undergoing primary cesarean delivery in Robson groups.
 
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