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CTRI Number  CTRI/2024/02/063052 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Hysterectomy in previous caesarean section 
Scientific Title of Study   Changing trends of caesarean hysterectomy in previous caesarean section : An observational study 
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Tiwari 
Designation  Junior Resident  
Affiliation  Rohilkhand Medical College  
Address  Obstetric and Gynaecology department, Rohilkhand Medical College Bareilly, Uttarpradesh
Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India 
Phone  9870952378  
Fax    
Email  kutkut94122@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kiran Agarwal 
Designation  Professor  
Affiliation  Rohilkhand Medical College  
Address  Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Bareilly
Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India 
Phone  9870952378  
Fax    
Email  kiranbly1956@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shweta Tiwari 
Designation  Junior Resident  
Affiliation  Rohilkhand Medical College  
Address  Obstetric and Gynaecology department, Rohilkhand Medical College Bareilly, Uttarpradesh
Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India 
Phone  9870952378  
Fax    
Email  kutkut94122@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of obstetrics and gynaecology  
Address  Rohilkhand Medical College And Hospital Bareilly, Uttar Pradesh 
Type of Sponsor  Private 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 Shweta Tiwari  Rohilkhand Medical College and Hospital   Department of obstetrics and gynaecology , Rohilkhand Medical College and Hospital
Bareilly
UTTAR PRADESH 
9870952378

kutkut94122@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly, UP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O71||Other obstetric trauma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  All pregnant female with previous caesarean section 1 or more who underwent obstetrical hysterectomy
Women with obstetric hysterectomy due to various reasons like atopic postpartum bleeding, unrepairable tear and inversion of uterus  
 
ExclusionCriteria 
Details  Primigravida
History of any gynaecological uterine surgeries like myomectomy, uterine septal defect and post abortal perforations( septic abortion , H. Mole) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine obstetrics hysterectomy with regards to frequency, indication, maternal risk
factors, complications in tertiary center. 
3 years 
 
Secondary Outcome  
Outcome  TimePoints 
2. To assess abnormal placentation in women with previous cesarean section is mostly Placenta previa and morbid adherent placenta which leads to Obstetrical Hysterectomies.  1year 
To analyze the possible reasons of very 1 high rate of Caesarean section cases  1year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   29/02/2024 
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="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  
All pregnant women who had previously delivered by C.S or Normal vaginal delivery present to our department in present pregnancy who undergoes Obstetrical Hysterectomy were considered for this study. All detailed history, clinical examination, Obstetrical examination were done and findings noted as per the protocol. USG was done in all women to assess foetal wellbeing with more attention to placental position and thickness of scar in previous CS.
Women were characterised on basis of abnormal placentation and other intraoperative or postoperative complications were noted. Postnatal complication with respect to intractable haemorrhage, extension of tear in uterus, scar delicences, uterine rupture due to obstructed labour who needed lifesaving hysterectomy are taken into consideration.
 
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