| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- 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.
- 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 |