| CTRI Number |
CTRI/2021/11/037716 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EPISCISSORS 60] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing two scissors-Episcissors 60 and the routine scissors-(Busch scissors) used for giving an episiotomy - to find out which scissors causes less injury to the anal sphincter |
|
Scientific Title of Study
|
EPISCISSORS-60 VERSUS BUSCH EPISIOTOMY SCISSORS - A RANDOMISED CONTROLLED TRIAL COMPARING EPISIOTOMIES AND INCIDENCE OF OASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR CHIPPY TESS MATHEW |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PSGIMSR |
| Address |
ROOM NO 3,DEPARTMENT OF OBSTETRICS AND GYNECOLOGY ,PSGIMSR,PEELAMEDU
COIMBATORE-641004
TAMILNADU
PSGIMSR,PEELAMEDU
COIMBATORE-641004
TAMILNADU
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9442581261 |
| Fax |
|
| Email |
chippybivin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHIPPY TESS MATHEW |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PSGIMSR |
| Address |
ROOM NO3,DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
PSGIMSR,PEELAMEDU
COIMBATORE-641004
TAMILNADU
PSGIMSR,PEELAMEDU
COIMBATORE-641004
TAMILNADU
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9442581261 |
| Fax |
|
| Email |
chippybivin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHIPPY TESS MATHEW |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PSGIMSR |
| Address |
ROOM NO 3,DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
PSGIMSR,PEELAMEDU
COIMBATORE-641004
TAMILNADU
PSGIMSR,PEELAMEDU
COIMBATORE-641004
TAMILNADU
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9442581261 |
| Fax |
|
| Email |
chippybivin@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSGIMSR.PEELAMEDU,COIMBATORE |
|
|
Primary Sponsor
|
| Name |
DRCHIPPY TESS MATHEW |
| Address |
ASSOCIATE PROFESSOR
ROOM NO 3,DEPARTMENT OF OBSTETRICS AND GYNECOLOGY ,PSGIMSR,PEELAMEDU
COIMBATORE-641004
TAMILNADU |
| 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 CHIPPY |
PSGIMSR,LABOUR WARD |
LABOUR WARD
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
PSGIMSR
PEELAMEDU
COIMBATORE
Coimbatore
TAMIL NADU |
9442581261
chippybivin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC PSGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O718||Other specified obstetric trauma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EPISCISSORS -60 is used for giving episiotomy |
We will have 200 patients whose episiotomy is done with scissors called EPISCISSORS 60 and 200 patients whose episiotomy is done with the routine scissors called Busch scissors. Then we compare the episiotomies. In the immediate postnatal period we measure the length of the episiotomy, angle from mid line and distance from anal sphincter AND incidence of anal sphincter injury. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida
Cephalic presentation
Normal/instrumental vaginal delivery
 |
|
| ExclusionCriteria |
| Details |
Multigravida
Any patient not willing to participate are exempted
Previous caesarean delivery
malpresentation
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-The episiotomy is measured in the postnatal period (IMMEDIATELY AFTER SUTURING-within half an hour of delivery) for length, angle from midline and distance from anal sphincter
-Incidence of OASIS also noted
|
-The episiotomy is measured in the immediate postnatal period
at BASELINE for length, angle from midline and distance from anal sphincter
-Incidence of OASIS also noted
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of OASIS also noted |
immediately after delivery within 10 minutes of placental delivery |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2021 |
| 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
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Episiotomy is a routine procedure done during the second stage of labour, to reduce the incidence of perineal injuries. Episiotomy if given too medially or too laterally doesn’t serve the purpose and can increase the incidence of OASIS (Obstetric Anal Sphincter InjurieS).Episiotomy is most effective if the angle is 45 degree from the midline after suturing. To attain this angle the episiotomy scissors should cut at an angle of 60degree from the midline when the perineum is bulging during delivery.
AIMS AND OBJECTIVES-) To compare the episiotomies using Episcissors-60 and Busch episiotomy scissors (length, distance from anal sphincter and angle of episiotomy) 2) To compare the incidence of OASIS with Episcissors-60 and Busch episiotomy scissors Study designPatients are randomised into Busch group and Episcissors-60 group using the randomisation table. Episiotomy is given at crowning of head .The episiotomy is measured in the postnatal period for length, angle from midline and distance from anal sphincter. Any incidence of OASIS is noted. Study population:It comprises of 200 patients who were given a mediolateral episiotomy using Episcissors-60 at the crowning of the foetal head (group 1). Another group of 200 patients who were given a mediolateral episiotomy using Busch episiotomy scissorsat the crowning of the foetal head (group2).Randomisation is done using a randomisation table online.
|