| CTRI Number |
CTRI/2024/03/064733 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the tears of birth canal in women who receive routine planned cut over birth canal during child birth versus who dont receive the planned cut among women who had previous term vaginal child birth |
|
Scientific Title of Study
|
Comparison of perineal tears with routine episiotomy versus no episiotomy among multiparous women with previous term vaginal delivery : A Randomized 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 |
Dr Rajeswari G |
| Designation |
junior resident |
| Affiliation |
Jawaharlal institute of postgraduate and medical research |
| Address |
Department of obstetrics and gynaecology,
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9789895392 |
| Fax |
|
| Email |
rajeegkrishnan97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gowri Dorairajan |
| Designation |
Professor and head of the department ,Department of obstetrics and gynaecology. |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of obstetrics and gynaecology,
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9789895392 |
| Fax |
|
| Email |
gowridorai@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Gowri Dorairajan |
| Designation |
Professor and head of the department ,Department of obstetrics and gynaecology. |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of obstetrics and gynaecology,
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9789895392 |
| Fax |
|
| Email |
gowridorai@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate and medical education |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Gorimedu, Dhanvantari Nagar, Puducherry, 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajeswari G |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of obstetrics and gynaecology,
Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY |
9789895392
rajeegkrishnan97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies CDSCO Reg.No.ECR/342/Inst/PY/2013/RR-19 |
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 |
episiotomy |
In this group,patients who are eligible based on inclusion and exclusion criterias will receive routine episiotomy as followed in our healthcare system and will be examined for composite perineal tears and complications associated with it immediately after delivery and are also further followed up after 24 hours in hospital and at 6 weeks after delivery through telephonic call with the help of medical social worker. |
| Comparator Agent |
No episiotomy |
In this group,patients who are eligible based on inclusion and exclusion criterias will not receive episiotomy and will be followed up for anycomposite perineal tears and complications associated with it immediately after delivery and after 24 hours in hospital and at 6 weeks after delivery through telephonic call with the help of medical social worker. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women in active labour with previous one vaginal delivery.
2.Singleton pregnancy
3.Vertex presentation
4.More than 37 weeks
5.Perineum more than 3.5 cm in first stage
6.Estimated Birth weight between 2.5 kg and 3.5kg
|
|
| ExclusionCriteria |
| Details |
1.Operative vaginal delivery
2.Previous complete perineal tear
3.Shoulder dystocia
4.Severe preeclampsia
5.Uncontrolled diabetes
6.Heart disease
7.Fetal distress in second stage needing to expedite delivery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the rates of composite perineal tears among routine and no episiotomy group at time of delivery .composite perineal tears include Vulvovaginal tears /extension of episiotomy,Occurrence of tears in perineum in the no episiotomy group that requires suturing ,Obstetric anal sphincter injuries(OASIs)
|
To compare the rates of composite perineal tears among routine and no episiotomy groups at the time delivery.composite perineal tears include Vulvovaginal tears /extension of episiotomy,Occurrence of tears in perineum in the no episiotomy group that requires suturing ,Obstetric anal sphincter injuries(OASIs).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate perineal pain on Visual Analogue Score at 24 hours after delivery
To evaluate perineal pain & other associated symptoms at 6 weeks after delivery.
|
To evaluate perineal pain on Visual Analogue Score at 24 hours after delivery
To evaluate perineal pain & other associated symptoms at 6 weeks after delivery.
|
|
|
Target Sample Size
|
Total Sample Size="364"
Sample Size from India="364"
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 1 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="6"
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
|
Episiotomy is a procedure done during childbirth where a small cut is made in the area between the vagina and the anus (perineum) to help with the delivery. This was initially thought to prevent severe tearing of perineum . It can cause complications like pain, bleeding, and difficulties during future intimate activities. The use of this method has become restrictive these days.Rates of episiotomy differs among various institutes .This study is done to compare the outcomes of routinely doing episiotomy versus not doing it.
|