| CTRI Number |
CTRI/2026/02/102818 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Continuous and Interrupted Suturing for Episiotomy Repair and Their Effect on Postpartum Pain and Healing in Women After Vaginal Delivery |
|
Scientific Title of Study
|
Continuous non locking versus interrupted suturing techniques for the repair of episiotomy: A Randomised Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiwangi Tewari |
| Designation |
Postgraduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Obstetric and Gynaecology department, Regional Institute Of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9632327530 |
| Fax |
|
| Email |
shiwangi.tewari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moirangthem Rameswar Singh |
| Designation |
Professor and HOD |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Obstetric and Gynaecology department, Regional Institute Of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
8119821188 |
| Fax |
|
| Email |
rameswardr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moirangthem Rameswar Singh |
| Designation |
Professor and HOD |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Obstetric and Gynaecology department, Regional Institute Of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
8119821188 |
| Fax |
|
| Email |
rameswardr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur 795004 |
|
|
Primary Sponsor
|
| Name |
Dr Shiwangi Tewari |
| Address |
Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur 795004 |
| 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 Shiwangi Tewari |
Regional Institute of Medical Sciences |
Obstetrics and Gynaecology department OPD, Obstetrics and Gynaecology department, RIMS, Lamphelpat
Imphal West
MANIPUR |
9632327530
shiwangi.tewari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O709||Perineal laceration during delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous non locking suturing technique |
Episiotomy repair will be performed using a continuous non-locking technique. The vaginal mucosa will be sutured continuously from the apex downward without tying knots between stitches. Perineal muscles will be approximated using a continuous suture with uniform tension. Skin closure will be achieved with a continuous subcuticular suture to provide a smooth surface with minimal scarring. Absorbable sutures such as polyglactin 910 will be used throughout. |
| Comparator Agent |
Interrupted suturing technique |
Episiotomy repair will be carried out using an interrupted suturing technique. The vaginal mucosa will be sutured with individually tied stitches. Perineal muscles will be reconstructed using interrupted sutures to ensure accurate layer approximation. Skin closure will be completed with interrupted transcutaneous stitches, each tied separately. Absorbable sutures such as polyglactin 910 will be used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy with cephalic presentation
Normal body mass index 18.5 to 22.9 kg/m2
Full term gestational age 37 to 41 weeks
Normal neonate weight 2.5 to 3.9 kg
Those who underwent mediolateral episiotomy
Those who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Women with HIV AIDS (acquired immunodeficiency syndrome)
Hepatitis B virus infection
HCV infection
Suspected genital infection
Extensive varicose veins of the external genitalia
3rd or 4th degree of perineal tears, and no access to a phone line (for follow-up)
Diabetes mellitus
Instrumental vaginal delivery |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
6,12,24,48 hours postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REEDA Scale |
Day 2 and 1 month post partum |
| Cosmetic disfigurement, patient satisfaction and anal sphincter dysfunction |
1 month post partum |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
13/02/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Episiotomy, a common obstetric procedure, requires careful repair to minimize postpartum complications such as pain, infection, and delayed wound healing. Two primary techniques used in episiotomy repair are the interrupted and continuous non-locking suture methods. The choice of technique can significantly influence maternal outcomes, especially in the early postpartum period. In the interrupted suture technique, each layer of the wound (vaginal mucosa, perineal muscles, and skin) is closed using individual stitches, each tied separately. While this method allows precise tissue approximation, it is time-consuming, uses more suture material, and introduces multiple knots that may irritate the healing tissue. As a result, women repaired with this technique often report higher levels of perineal pain and a greater need for analgesics. |