| CTRI Number |
CTRI/2025/08/092537 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Episiotomy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of episiotomy on the mother and her newborn. |
|
Scientific Title of Study
|
Obstetric Outcome In Parturiant Women Without Episiotomy Versus With Episiotomy- A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srishti Kalra |
| Designation |
Resident doctor |
| Affiliation |
NKP Salve Insititute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital |
| Address |
Labour room, Department of Obstetrics and Gynecology, NKP Salve Institute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9757090304 |
| Fax |
|
| Email |
srishtikalra11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuja Bhalerao |
| Designation |
HOD and Professor |
| Affiliation |
NKP Salve Institute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital |
| Address |
Labour room, Department of Obstetrics and Gynecology,NKP Salve Institute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9823680572 |
| Fax |
|
| Email |
Anujab803@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishti Kalra |
| Designation |
Resident doctor |
| Affiliation |
NKP Salve Insititute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital |
| Address |
Labour room, Department of Obstetrics and Gynaecology, NKP Salve Institute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9757090304 |
| Fax |
|
| Email |
srishtikalra11@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sciences and Research Center and Lata Mangeshkar Hospital, Digdoh hills, Hingna, Nagpur, Maharashtra-440019 |
|
|
Primary Sponsor
|
| Name |
NKP Salve Insititute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital |
| Address |
NKP Salve Insititute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur, Maharasthra-440019 |
| Type of Sponsor |
Private medical college |
|
|
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 Srishti Kalra |
NKP Salve Institute of Medical Sciences and Research Center and Lata Mangeshkar Hospital |
Department of Obstetrics and Gynaecology, NKP Salve Institute of Medical Sciences and Research Center and Lata Mangeshkar Hospital , Digdoh Hills, Hingna Road, Nagpur, Maharashtra-440019
Nagpur
MAHARASHTRA |
9757090304
srishtikalra11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL Ehical COMMITTEE, N.K.P. SALVE INSTITUTE OF MEDICAL SCIENCES & RC AND LATA MANGESHKAR HOSPITAL NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Episiotomy |
A Right Medio-Lateral Episiotomy is given to parturiant women for easy Vaginal delivery of the baby. Hence this is a Randomised Controlled Trial to study the outcome Of Episiotomy and no Episiotmy on parturiant women and their newborn. The Episiotomy would be given at the time of crowning. The duration of intervention as Episiotomy is only during the second stage of labour lasting for approximately one hour. Duration of intervention 1 hour |
| Comparator Agent |
Non Episiotomy |
No Episiotomy would be given and its effect on parturiant women and her new-born would be assessed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Low risk primary and multigravida women between 37 to 42 weeks of gestation, singleton pregnancy, cephalic presentation, occipito-anterior position with adequate pelvis presenting in active stage of labour
2. Baby weightless than 3 Kg
3. Those willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Women requiring cesarean section during second stage of labour.
2. Maternal and fetal distress |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maternal outcomes:
1. Duration of second stage of labour
2. Frequency and degree of perineal tear
3. Postpartum pain
4. Postpartum requirement of analgesia
Neonatal outcomes:
1. APGAR score at 1 min
2. APGAR score at 5 mins
3. Requirement of neonatal resuscitation
4. NICU admission
|
Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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
|
Parturiant women admitted in the Labour room at NKP Salve Institute of Heath Sciences and Research Center and Lata Mangeshkar Hospital are being recruited in the trial depending on inclusion and exclusion criteria. The parturient women are divided in two groups - with Episiotomy and without Episiotomy and then effects on both mother and newborn are well evaluated. |