| 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
|
|
|
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
|
|
|
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
|
|
|
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. |