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CTRI Number  CTRI/2026/02/103044 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Caesarean Scar Defect - Prevalence and Clinical Profile 
Scientific Title of Study   Prevalence and clinical profile of Caesarean Scar Defect after Caesarean Delivery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mehak Aroa 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9501928083  
Fax    
Email  aroramehak259@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mehak Aroa 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9501928083  
Fax    
Email  aroramehak259@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mehak Aroa 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Obstetrics and Gynaecology, AIIMS, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9501928083  
Fax    
Email  aroramehak259@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  AIIMS, Ansari Nagar East New Delhi - 110029 
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 Mehak Arora  AIIMS  Department of Obstetrics and Gynaecology, AIIMS, New Delhi - 110029
New Delhi
DELHI 
9501928083

aroramehak259@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe for Post graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O342||Maternal care due to uterine scarfrom previous surgery, (2) ICD-10 Condition: O342||Maternal care due to uterine scarfrom previous surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LNG IUS  Insertion of LNG IUS in patients opting for the same 
Comparator Agent  No intervention  No treatment given 
Comparator Agent  OCP  OCP pills administered to symptomatic patients opting for the same 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Patients delivered by caesarean delivery from Jan 2021 to June 2025 at AIIMS, New Delhi, more than 6 months before the date of recruitment
CD done for any indication
Patients who have one or more CD 
 
ExclusionCriteria 
Details  Patients with underlying pre-existing uterine pathologies: endometriosis, adenomyosis, fibroid uterus, Mullerian Anomalies
Age less than 18 years
Patients who have undergone CS less than 6 months ago
Women with classical caesarean section
History of uterine surgeries
Postpartum insertion of an intrauterine contraceptive device (IUCD)
Pregnancy at follow up
Active genital tract infection at follow-up
Refusal to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Presence or absence of CSD
 
After mor than or equal to 6 months have passed the caesarean section
 
 
Secondary Outcome  
Outcome  TimePoints 
Presence or absence of symptoms in CSD
Presence of CSDi
Type of symptoms associated with CSD
Risk factors for development of CSD
Various parameters of CSD measurement & its relation to severity & type of symptoms
Proportion of patients with AUB-N accepting OCPs & LNG-IUS
Proportion of patients with AUB-N responding to OCPs & LNG-IUS
 
After more than or equal to 6 months have passed from the caesarean section 
 
Target Sample Size   Total Sample Size="323"
Sample Size from India="323" 
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)   25/02/2026 
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  

Cesarean section rates have been rising significantly over recent years, more so in western world; increasing from 14.5% to 27.2% between the years 2000 and 2017. As per a report by the World Health Organization, roughly 18.5 million women undergo CS annually.The rise in caesarean section deliveries in India also has become a notable public health concern. Rise in the number of deliveries by CS has inevitably resulted in prevalence of its complications, both in short and long term. While C-sections can be lifesaving when medically indicated, their overuse can lead to significant health risks for both mothers and infants, including infections, prolonged recovery times, and increased healthcare costs. One important long term complication is Caesarean Scar defect (CSD) also known as Isthmocoele or Niche.The paucity of Indian research on caesarean scar disorder (CSD) highlights a critical gap in understanding the long-term implications of rising caesarean delivery rates in the country. Despite the increasing incidence of CSD and its associated complications, such as chronic pelvic pain, abnormal bleeding, and infertility, there is a notable lack of focused studies addressing its etiology, diagnosis, and management within the Indian context. This gap is concerning as it limits the ability to formulate effective preventive strategies and treatment protocols tailored to local needs. Furthermore, as caesarean sections become more common, the potential long-term sequelae of CSD—such as uterine rupture or placenta accreta—assume greater significance.  Therefore, there is an urgent need for comprehensive research initiatives in India to investigate the multifactorial aspects of CSD, including surgical techniques, patient demographics, and cultural factors influencing healthcare decisions. Addressing this research deficit will not only improve clinical outcomes but also enhance overall maternal health care in India.The aims of this study is to evaluate the incidence of CSD and CSDi by using standard definitions of both. 

 
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