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CTRI Number  CTRI/2025/12/098244 [Registered on: 01/12/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effectiveness of preoperative diagnostic methods in predicting intra peritoneal adhesions in women undergoing repeat lscs : one year observational study 
Scientific Title of Study   Effectiveness of Preoperative Diagnostic Methods in Predicting Intra peritoneal Adhesions in Women Undergoing Repeat LSCS : One year Observational Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  palak rathi 
Designation  junior resident 
Affiliation  jahwarlal nehru medical college 
Address  KLEs Dr Prabhakar Kore Hospital OBGYN Department Nehru nagar belagavi g-1 labor room
KLEs Dr Prabhakar Kore Hospital OBGYN Department, Nehru nagar belagavi g-1 labor room
Belgaum
KARNATAKA
590001
India 
Phone  8668338444  
Fax    
Email  palakrathi2201@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr . Mahadevi Savanur  
Designation  ASSOCIATE PROFESSOR  
Affiliation  jahwarlal nehru medical college 
Address  KLEs Dr Prabhakar Kore Hospital , Nehru nagar belagavi g-1 labor room
KLEs Dr Prabhakar Kore Hospital , Nehru nagar belagavi g-1 labor room
Belgaum
KARNATAKA
590001
India 
Phone  9880515045  
Fax    
Email  drdevim30@gmail.com  
 
Details of Contact Person
Public Query
 
Name  palak rathi 
Designation  junior resident 
Affiliation  jahwarlal nehru medical college 
Address  KLEs Dr Prabhakar Kore Hospital OBGYN Department , Nehru nagar belagavi g-1 labor room
KLEs Dr Prabhakar Kore Hospital OBGYN Department , Nehru nagar belagavi g-1 labor room
Belgaum
KARNATAKA
590001
India 
Phone  8668338444  
Fax    
Email  palakrathi2201@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  palak rathi  
Address  KLEs Dr Prabhakar Kore Hospital , Nehru nagar belagavi g-1 labor room  
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 
palak rathi  KLEs Dr Prabhakar Kore Hospital  KLEs Dr Prabhakar Kore Hospital OBGYN Department , Nehru nagar belagavi 590001 g-1 labor room
Belgaum
KARNATAKA 
8668338444

palakrathi2201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
jnmc institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O098||Supervision of other high risk pregnancies,  
 
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  Antenatal women with history of previous caesarean undergoing repeat caesarean delivery 
 
ExclusionCriteria 
Details  women with previous history of pelvic or abdominal surgery other than lscs like myomectomy appendectomy
women with history of pelvic inflammatory disease
women with history of endometriosis
women with history of previous surgical site infection following cesarean delivery
women with history of prolonged corticosteroid use
women with vertical scar
women who are not willing to participate  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to study the effectiveness of preoperative diagnostic methods morphological characteristics of abdominal skin scar presence or absence of striae graviadrum presence or absence of sliding sign on trans abdominal use in predicting intraperitoneal adhesions in women undergoing repeat caesarean delivery   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
to identify & analyse potential risk factors associated with development of intraperitoneal adhesions in women undergoing repeat caesarean delivery  1 year 
 
Target Sample Size   Total Sample Size="194"
Sample Size from India="194" 
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)   11/12/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 09-09-2025 and end date provided 28-09-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This research study is titled Effectiveness of Pre Operative Diagnostic Methods in Predicting Intra Peritoneal Adhesions in Women Undergoing Repeat Caesarean Delivery  A One Year Observational Study  Overview of the Study The study is a prospective observational study conducted at KAHERS Dr Prabhakar Kore Hospital in Belagavi The primary goal is to determine if certain preoperative diagnostic methods specifically the characteristics of the previous caesarean section CS scar the presence of striae gravidarum stretch marks and a specific ultrasound finding called the sliding sign can predict the existence and severity of intraperitoneal adhesions in women undergoing a repeat CS A secondary goal is to identify other potential risk factors for these adhesions Methodology and Participants The study plans to enroll 194 antenatal women in their third trimester who have a history of at least one previous CS Patients will undergo a preoperative assessment that includes a physical examination of their abdominal scar and striae as well as a transabdominal ultrasound to check for the sliding sign During the repeat CS the researchers will assess the presence and severity of adhesions The preoperative findings will then be correlated with the actual intraoperative findings to evaluate the diagnostic methods predictive accuracy Key Findings and Budget The study budget is approximately rs18000 which covers expenses for informed consent proforma documents and the statisticians fees Participants will not receive any financial benefit  and their participation is entirely voluntary The study emphasizes maintaining patient confidentiality by coding all collected data

 
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