| CTRI Number |
CTRI/2025/10/096042 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Single Layer Closure Of Uterus With That Of Double Layer Closure In Cesarean Section |
|
Scientific Title of Study
|
A Comparative Study Of Residual Myometrial Thickness Following Elective And Emergency Cesarean Section Using Single Layer Versus Double Layer Uterine Closure Techniques. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charitha Guttireddy |
| Designation |
Junior Resident |
| Affiliation |
Shri B M Patil Deemed To Be University |
| Address |
Obg Opd 2 ,
Department Of Obstetrics And Gynaecology.
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Karnataka
586103
Obg Opd 2 ,
Department Of Obstetrics And Gynaecology
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Karnataka
586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9381898502 |
| Fax |
|
| Email |
charitha212015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasri Yaliwal |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Deemed To Be University |
| Address |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9381898502 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajasri Yaliwal |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Deemed To Be University |
| Address |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@blde.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
BLDE(DU) Shri B M Patil Medical College, Hospital and Research Center |
| Address |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BLDEDU Shri B M Patil Medical College Hospital and Research Center |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Charitha Guttireddy |
BLDE (DU) Shri B M Patil medical college ,hospital and research centre |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103
Bijapur
KARNATAKA |
9381898502
charitha212015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance |
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 |
Group 1: Single-layer closure of uterus with continuous locking stitch in elective cesarean section |
Suture material used - polyglactin 910 no.1 |
| Comparator Agent |
Group 2: double layer uterine closure with continuous stitch(unlocked) in elective cesarean section |
suture material used- polyglactin 910 no.1 |
| Comparator Agent |
Group 3:single layer uterus closure with continuous locking stitch in emergency cesarean section |
suture material used-polyglactin 910 no.1 |
| Comparator Agent |
Group 4: double-layer uterus closure with continuous stitch (unlocked) in emergency caesarean section. |
Suture material used – polyglactin 910 no. 1 . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Maternal age between 18 to 40 years
Period Of Gestation Between 37 Weeks To 42 Weeks.
Primary Section. |
|
| ExclusionCriteria |
| Details |
Multi Fetal Gestation
Thrombophilias
Mullerian Anamolies
Women With Predisposing Conditions To Post Partum Hemorrhage Such As Coagulation Disorders ,Antepartum Hemorrhage,Hypertensive Disorders Of Pregnancy,Women Receiving General Anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the residual myometrial thickness in single layer and double layer uterine closure during elective vs emergency cesarean delivery |
To evaluate the residual myometrial thickness in single layer and double layer uterine closure during elective vs emergency cesarean delivery after 7 days of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess & compare the blood loss in single layer & double layer closure of the uterus during cesarean delivery.
To assess & compare the operative time taken in single layer & double layer closure of uterus during cesarean delivery.
|
To assess & compare the blood loss in single layer & double layer closure of the uterus during cesarean delivery
To assess & compare the operative time taken in single layer & double layer closure of uterus during cesarean delivery. The follow up scan will be done on post Operative day 7
|
|
|
Target Sample Size
|
Total Sample Size="208"
Sample Size from India="208"
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)
|
01/11/2026 |
| 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="6"
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-identification.
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [charitha212015@gmail.com].
- For how long will this data be available start date provided 20-09-2025 and end date provided 20-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Residual myometrial thickness is an important marker for uterine scar integrity. Surgical technique, including type of uterine closure (single vs double layer) and the urgency of the operation (elective vs emergency) may definitely influence postoperative healing and scar integrity, measured as residual myometrial thickness.Comparing between single layer closure ,double layer locked first layer and double layer unlocked first layer, double layer unlocked first layer closure was associated with thicker RMT . Therefore double layer closure with unlocked first layer is associated with better uterine scar healing than locked single layer. Single layer closure and locked first layer are associated with lower residual myometrial thickness.
|