| CTRI Number |
CTRI/2022/06/042975 [Registered on: 02/06/2022] Trial Registered Prospectively |
| Last Modified On: |
24/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Different instrument is being used ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of the accuracy of given a 60 degree angle of episiotomy between Episcissor-60 and regular mayo scissor, and assess its role in preventing obstetric sphincter injuries |
|
Scientific Title of Study
|
Comparison of the accuracy of Episcissor-60 with Mayo scissors in performing a mediolateral episiotomy- a randomized control trial for a duaration of 1 year in a tertiary care center. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Managaonkar |
| Designation |
Post Graduate |
| Affiliation |
KLE University |
| Address |
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College
Kle university
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9535628987 |
| Fax |
|
| Email |
shivaninm123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hema Patil |
| Designation |
Associate Proffesor |
| Affiliation |
KLE University |
| Address |
Associate Proffessor
Department Of Obstetrics and Gynaecology
JNMC
KLE univeristy
Belgaum
KARNATAKA
590010
India |
| Phone |
9164342888 |
| Fax |
|
| Email |
hemabanad@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Managaonkar |
| Designation |
Post Graduate |
| Affiliation |
KLE University |
| Address |
Department Of Obstetrics and Gynecology
Jawaharlal nehru medical college
Kle univerisity
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9535628987 |
| Fax |
|
| Email |
shivaninm123@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Prabhakar Kore Charitable Hospital |
|
|
Primary Sponsor
|
| Name |
Shivani Managaonkar |
| Address |
KLE University
belgaum |
| 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 Shivani Managaonkar |
KLE PRABHAKAR KORE CHARITABLE HOSPITAL |
Free Labour Ward
Dept of OBGYN
KLE PRABHAKR KORE CHARITABLE HOSPITAL
BELGAUM-590010
Belgaum
KARNATAKA |
9535628987
shivaninm123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O719||Obstetric trauma, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EPISCISSOR-60 |
Usage of Episcissor 60 in giving mediolateral episiotomy for the study period |
| Comparator Agent |
regular MAYO scissor |
Mayo scissor is used to given episitomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida
multigravida
VBAC |
|
| ExclusionCriteria |
| Details |
previous obstetric phincter injury
assisted vaginal delivery
instrumental delivery |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess significance of the accurately angled of episiotomy with the use of Episcissor-60 in reduction in obstetric anal sphincter injuries |
the assessment is done immediately, after 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess accuracy of the angle of episiotomy incision with usage of fixed angle scissor
to assess clinical significance in reducing perineal infection |
assessed at 24 hours, and after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
06/06/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Episiotomy is the most commonly performed procedure, and an inaccurately performed episiotomy can risk in obstetric anal sphincter injuries and hold ground for medical negligence, there are various factors of episiotomy that govern the adequacy and accuracy of the episiotomy and reflect on the incidence of perineal tears. the angle recommeded is between 40-60 degrees. in this study we are comparing the angle of episiotomy between the regular Mayo scissor and the episcissor-60 which is a patented pre fixed scissor and its accuracy in prevention of obstetric tears and perianal injuries. the secondary objective is to detect the rate of perineal injuries and infection rate and compare between the scissors. |