| CTRI Number |
CTRI/2026/03/106594 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Suture comparison] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to Compare vicryl 2-0 dyed with rapidly absorbing vicryl 2-0 for episiotomy repair |
|
Scientific Title of Study
|
Randomised controlled trial of Comparison of polyglactin 910 2-0 dyed with rapidly absorbing polyglactin 910 2-0 for episiotomy repair |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nishika yadav |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC |
| Address |
Department of OBG, Dr. RPGMC TANDA, tanda hospital road, near pushp viharcolony, kangra . Himahal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8989625532 |
| Fax |
|
| Email |
ynishikany20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ajay sood |
| Designation |
Professor |
| Affiliation |
Dr. RPGMC Tanda |
| Address |
Department of OBG Dr. RPGMC TANDA. Tanda hospital road, near pushp vihar colony, kangra, Himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816021100 |
| Fax |
|
| Email |
ajayshalu95@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishika yadav |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC |
| Address |
Department of obg , dr. RPGMC TANDA, tanda hospital road , near pushp vihar colony, kangra, himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8989625532 |
| Fax |
|
| Email |
ynishikany20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nishika Yadav |
| Address |
DR RPGMC TANDA |
| 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 |
| Dr Nishika Yadav |
DR RPGMC TANDA |
Labor room, first floor, department of obg
Kangra
HIMACHAL PRADESH |
8989625532
ynishikany20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Dr RPGMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vicryl 2-0 |
Vicryl 2-0 will be used for episiotony repair |
| Comparator Agent |
Vicryl 2-0 rapid |
Vicryl 2-0 rapid will be used for episiotomy repair |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy |
|
| ExclusionCriteria |
| Details |
Severe anemia
HIV , HBsag, Anti HCV positive
Deranged coagulation profile |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perineal pain |
24 hours
7days
6 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Perineal pain
Dyspareunia
Hematoma
Resuturing
Gaping
Suture felt at coitus |
7days
6 weeks
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
28/03/2026 |
| 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="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
|
Comparison of vicryl 2 0 vs rapid vicryl 2 0 in episiotomy repair |