| CTRI Number |
CTRI/2025/08/093541 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting internal scarring in women undergoing repeat C-section using clinical sign and ultrasound. |
|
Scientific Title of Study
|
PREDICTION OF INTRAABDOMINAL ADHESIONS IN WOMEN UNDERGOING REPEAT CESAREAN DELIVERY USING CLINICAL FEATURES & ULTRASONOGRAPHIC SLIDING SIGN. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reena Kumari |
| Designation |
PG Resident |
| Affiliation |
Dr BSA Medical College and Hospital |
| Address |
Room no 03
Department of Obstetrics and Gynecology Obstetrics & Gynecology Division
Dr BSA Medical College and Hospital Sector 6 Rohini
New Delhi
North West
DELHI
110085
India |
| Phone |
9673897924 |
| Fax |
|
| Email |
ojha.dr.reena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Chadha |
| Designation |
Professor |
| Affiliation |
Dr BSA Medical College and Hospital |
| Address |
Room no 01
Department of Obstetrics and Gynecology Obstetrics & Gynecology Division
Dr BSA Medical College and Hospital Sector 6 Rohini
New Delhi
North West
DELHI
110085
India |
| Phone |
7065023133 |
| Fax |
|
| Email |
shikhapasrija@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena Kumari |
| Designation |
PG Resident |
| Affiliation |
Dr BSA Medical College and Hospital |
| Address |
Room no 03
Department of Obstetrics and Gynecology Obstetrics & Gynecology Division
Dr BSA Medical College and Hospital Sector 6 Rohini
New Delhi
North West
DELHI
110085
India |
| Phone |
9673897924 |
| Fax |
|
| Email |
ojha.dr.reena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BSA Medical College and Hospital Sector 6 Rohini
New Delhi India
Pin code -110085 |
|
|
Primary Sponsor
|
| Name |
Dr BSA Hospital |
| Address |
Dr BSA Medical College and Hospital Sector 6 Rohini
New Delhi India
Pin code-110085 |
| 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 Reena Kumari |
Dr BSA Hospital |
Room no 03
Department of Obstetrics and Gynecology Obstetrics & Gynecology Division
Dr BSA Medical College and Hospital Sector 6 Rohini
New Delhi
North West
DELHI |
9673897924
ojha.dr.reena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr BSA Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women with gestational age at or beyond 37 weeks with previous cesarean section, planned for repeat cesarean section. |
|
| ExclusionCriteria |
| Details |
1. Women with known collagen disorders.
2. Women with h/o radiation therapy.
3. Placenta Accreta spectrum disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The accuracy of predicting intra-abdominal adhesions (Scar tissue) before surgery using clinical signs and ultrasound sliding sign. |
Baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Longer surgical time.
2. Increased blood loss.
3. Difficulty in fetal delivery.
4. Need for additional surgical procedure. |
Baseline. |
|
|
Target Sample Size
|
Total Sample Size="233"
Sample Size from India="233"
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)
|
05/09/2025 |
| 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 - NO
|
|
Brief Summary
|
The fibrous bands formed between organs and abdominal walls are called adhesions. The Intra Abdominal adhesions are common complications following abdominal surgeries, including cesarean deliveries. The intra abdominal adhesions are frequently encountered during repeat cesarean delivery and are aggravated in prevalence and severity in multiple cesarean delivery. Adhesiolysis may result in delayed fetal extraction, injury to adjacent viscera, blood loss and prolonged surgery time. These adhesions can lead later to morbidity like bowel obstructions, infertility, ectopic pregnancy, chronic abdominal and pelvic pain along with dificulty insubsequent surgery.The incidence of adhesions correlates with prior number of cesarean sections. In first cesarean sections the chances of adhesions are 25-46% and increased to 43-75% in second cesarean section and upto 83% in subsequent cesarean section. Riskfactors for adhesions are smoking, history of chronic illness (like diabetes, collagen disease), post-op infection, peritoneal trauma and presence of blood clots following surgery. In contrast, peritoneal and rectus muscle closure are open to debate as a preventive measure against the formation of post cesarean adhesions.The rate of cesarean delivery has increased dramatically in recent years. The rising cesarean section rates can be attributed to rising multiple pregnancy rates, maturing mothers andmedico-legal concerns. Based on data obtained from around 150 countries, the rates of cesarean delivery in diferent regions range from 7.3% to 40.5%. In India, the proportion of cesarean deliveries has increased to 21.5% (2019-21) from just 3% in 1992-93 . Inproportion to these, rates of repeat cesarean section have increased as compared to VBAC. Many women do not consent for TOLAC (trial of labour after cesarean section) and want repeat cesarean section as the family size is limited these days and parents are not willing to take the risk involved. Also, obstetricians are bent towards cesarean delivery due to medico-legal issues.The importance of early detection of adhesions cannot be underestimated as a step towards reducing intraoperative complications. One can plan cesarean in a better manner involving experienced surgeons and can also reduce further adhesion formation by using adequate measures.considering these facts various authors have tried to correlate risk factors inhistory, previous cesarean characteristics, severity of striae, features of abdominal scar andsliding sign on ultrasound to predict presence and severity of intra abdominal adhesion. Striae are linear skin changes in the areas of skin stretching that occur because of dermal damage.it is believed that striae gravidarum, abdominal scar and peritoneal adhesions share similar pathway of healing characteristics. Thus, severity of striae and abdominal scar can be used to predict intra abdominal adhesion. The sensitivity for prediction of intra abdominal adhesions using striae varies from 0.45% to 47.7% whereas specificity varies from 0.89% to 67.6%. Predictive value using striae parameters is ranging from 1.518 to 45 . Prediction using scar features has been studied by several authors but results are not very promising. Also there is a lot of heterogeneity in the studies, sensitivity in predicting intraabdominal adhesions prediction using scar characteristics varies from 0.38 % to 77.35% whereas specificity varies from 0.88% to 58.19%. Predictive value using scar characteristics ranging from 2.405 to 42. Sliding sign has been used to predict adhesions in women undergoing repeat cesarean with good specificity. In this sliding of the uterus against the abdominal wall is observed. When no movement is observed, the sliding sign is negative. The sonographic sliding sign has been shown to have variable predictive value for the detection of pelvic adhesions in diferent studieswith sensitivity ranging from 53.3 % to 76.2% and specificity ranging from 80.4% to 95%. There have been trials for prediction of intra abdominal adhesions. We wish to assess the role of clinical features and sliding sign in prediction of intra abdominal adhesions in women undergoing repeat cesarean section as this is a very frequent problem and till date there is no method to accurately predict adhesions preoperatively. We will try to correlate risk factors in history, severity of striae, features of abdominal scar and sliding sign on ultrasound to predict presence and severity of intra abdominal adhesions. |