| CTRI Number |
CTRI/2024/02/062864 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Episotomoy which is better for less pain |
|
Scientific Title of Study
|
Mediolateral episotomoy |
| Trial Acronym |
Monocryl suture |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahalakshmi Gaddi |
| Designation |
Assistant professor |
| Affiliation |
Sdm college of medical sciences and hospital |
| Address |
Sdm medical College and hospital
Dharwad 580009
SDM staff quarters
Ratnashri vihar
Dharwad
KARNATAKA
580009
India |
| Phone |
9686991664 |
| Fax |
|
| Email |
mahagaddi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahalakshmi Gaddi |
| Designation |
Assistant professor |
| Affiliation |
Sdm college of medical sciences and hospital |
| Address |
Sdm medical College and hospital
Dharwad 580009
SDM staff quarters
Ratnashri vihar
Dharwad
KARNATAKA
580009
India |
| Phone |
9686991664 |
| Fax |
|
| Email |
mahagaddi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahalakshmi Gaddi |
| Designation |
Assistant professor |
| Affiliation |
Sdm college of medical sciences and hospital |
| Address |
Sdm medical College and hospital
Dharwad 580009
SDM staff quarters
Ratnashri vihar
Dharwad
KARNATAKA
580009
India |
| Phone |
9686991664 |
| Fax |
|
| Email |
mahagaddi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sdm College of medical sciences and hospital |
|
|
Primary Sponsor
|
| Name |
SDM College of medical sciences and hospital |
| Address |
Sdm Dharwad 580009 |
| 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 |
| Principal |
Sdm college of medical sciences and hospital |
Sdm College of medical sciences and hospital
Dharwad
KARNATAKA |
0836247777
principal@sdmmedicalcollege.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sdm college of medical sciences and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous |
Continuous method of suturing of vagina perineum and subcutaneous tissue |
| Comparator Agent |
Interrupted |
It involves continuous suturing of vagina, interrupted suturing of perineal muscle and interrupted mattress sutures of transcutaneous layer |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Term delivery
Delivery without instrumentation
Delivery without congenital anomalies
Assisted breech delivery
Parity less than or equal to 2 |
|
| ExclusionCriteria |
| Details |
Parity more than 3
Comorbidities like diabetes,renal disorders,liver disorders, heart disease
Hemoglobin less that 8
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the best technique of suturing of episotomoy |
To determine the best technique of suturing of episotomoy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the pain and conformability |
Pain |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="100"
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)
|
25/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Episotomoy suturing by continuos and interrupted suturing will be compared in terms of pain and conformability |