| CTRI Number |
CTRI/2026/01/102175 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Non Drug Intervention ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to compare Uterine closure time in Barbed vs Conventional suture at Cesarean section |
|
Scientific Title of Study
|
A Randomised Clinical trial comparing hysterotomy closure time at Cesarean Section using barbed sutures vs conventional smooth sutures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zee Shan Ali Manhas |
| Designation |
PG Student |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8082070263 |
| Fax |
|
| Email |
zm63325@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashank Shekhar |
| Designation |
Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996917 |
| Fax |
|
| Email |
longshanks28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zee Shan Ali Manhas |
| Designation |
PG Student |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8082070263 |
| Fax |
|
| Email |
zm63325@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology ,
AIIMS Jodhpur, Rajasthan ,India (3420005 ) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Zee Shan Ali Manhas |
AIIMS Jodhpur |
Department of Obstetrics and Gynaecology/IPD/Labor room/OPD/Gynaec OT
Jodhpur
RAJASTHAN |
8082070263
zm63325@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trial) All India Institute of Medical Sciences , Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant females who need Cesarean section for termination of pregnancy
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Barbed suture in intervention group |
Barbed suture is used in closing hysterotomy incision at cesarean section , may take 3 to 6 mins depending upon Surgeons skill |
| Comparator Agent |
Vicryl suture in control group |
Vicryl suture used for closure of hysterotomy incision at cesarean section, may take 3 to 6 mins depending upon surgeons skill |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients undergoing an Elective Cesarean section at term Gestation
2.Laboring patients who require an Emergency Cesarean section
|
|
| ExclusionCriteria |
| Details |
1. Deranged blood coagulation profile
2. Placenta Previa
3. Placenta Accreta Spectrum
4. Transverse Lie
5. Lower segment myomas
6. Previous Cesarean sections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to compare closure time of the uterine incision at cesarean section using barbed sutures vs conventional sutures. |
Patient will be assessed at 1, 3 and 6 months postnatally. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Perceived Surgeon satisfaction with the barbed suture closure of hysterotomy at cesarean section
2.The need for the additional hemostatic sutures
3 . Total Operating time
4. Secondary Postpartum hemorrhage
5. Cesarean scar thickness at 1,3 & 6 months
|
1, 3 & 6th month postnatally |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
10/02/2026 |
| 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="2"
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
|
This clinical trial aims to evaluate the efficiency of barbed sutures in closing uterine incision in comparison to conventional Smooth sutures.Weexpect there will be a decrease in uterine closure time, total operating time, number of hemostatic sutures needed , amount of blood loss during cesarean section and better surgeon satisfaction.
|