| CTRI Number |
CTRI/2024/03/064111 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ Episiotomy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of the impact of delivery without episiotomy among
primigravida
women |
|
Scientific Title of Study
|
A randomised controlled trial to study the outcome of ‘Routine episiotomy’ versus ‘No episiotomy’ on
perineal injury and pelvic floor dysfunction during normal vaginal delivery among primigravida
women: A Pilot study |
| 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 Archana Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room no. 727, MCH Block Department of Obstetrics and Gynecology,
South
DELHI
110029
India |
| Phone |
9868308594 |
| Fax |
|
| Email |
drarchanaaiims0312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room no. 727, MCH Block Department of Obstetrics and Gynecology,
South
DELHI
110029
India |
| Phone |
9868308594 |
| Fax |
|
| Email |
drarchanaaiims0312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room no. 727, MCH Block Department of Obstetrics and Gynecology,
South
DELHI
110029
India |
| Phone |
9868308594 |
| Fax |
|
| Email |
drarchanaaiims0312@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, |
| Address |
New Delhi |
| Type of Sponsor |
Government 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 Archana Kumari |
All India Institute of Medical Sciences |
Room no. 727, MCH Block Department of Obstetrics and Gynecology,
Ansari Nagar East Campus. AIIMS,
South
DELHI |
9868308594
drarchanaaiims0312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS, New Delhi |
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 |
| Comparator Agent |
No episiotomy |
Episiotomy will not be given and either the perineum will tear or remain intact |
| Intervention |
Routine episiotomy |
Mediolateral episiotomy will be
performed using specific episiotomy scissors at the time of crowning during second stage of
labour. Local anaesthesia( Injection lidocaine) will be given in the hymeneal plane, 1mL
subcutaneously at the incision point and 9mL in a fan-like fashion from the incision point.
Distance from incision point to the posterior fourchette between 1-3 cm and angle from the sagittal
or parasagittal plane: 60° (45°–80°, aim at the ischial tuberosity). Length of the incision: 4 cm (3–5
cm). Thickness of perineum just before delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women with singleton cephalic presentation age 18 yrs to 40 yrs
Antenatal women admitted in the third trimester with singleton pregnancy having a cephalic presentation at more than 34 weeks who are expected to have a normal vaginal delivery |
|
| ExclusionCriteria |
| Details |
1. Any contraindication of vaginal delivery
2. Pregnancies with multiple gestations
3. Estimated fetal weight more than 3 Kg
4. Previous surgery for incontinence and prolapse
5. Women with bleeding disorders or anticoagulation
6. Women with occipito posterior position. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1st Outcome Grade of perineal injury by digital examination by senior obstetrician according to RCOG 2017 along with number of tears direction of tears and length of tears
Characteristics of suturing including duration of suturing, number of suture packs used, subjective grading
of suturing difficulty and need for extended suturing in the operation room
2nd outcome Perineal pain evaluation using 11 points verbal numeric scale
Urinary retention for more than 6 h after delivery urinary catheter extraction
Symptoms of pelvic floor dysfunction
3rd Outcome
Questionnaire for postpartum pelvic floor outcomes among study participants
Anal incontinence is assessed by St Marks Vaizey incontinence score
Urinary incontinence is assessed International Consultation on incontinence questionnaire
short form
Impact on pelvic floor will be assessed by Pelvic floor impact questionnaire Short form
Resumption of sexual activity |
1st With in 24 hours after delivery
2nd At 36 hrs after delivery
3rd At 3 months after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
With in 24 hours after delivery
Duration of second stage of labour
Perineal pain and childbirth experience on Visual Analogue Scale
Need for pain killer, frequency of use of pain killer or epidural top ups or iv paracetamol,flexon,other
analgesics
Parauretheral tears
Need for instrumental delivery |
With in 24 hours after delivery |
Need for pain killer or frequency of use of pain killer or epidural top ups or iv paracetamol or flexon or other
analgesics |
At 36 hours after delivery |
| Dyspareunia |
At 3 months after delivery
|
|
|
Target Sample Size
|
Total Sample Size="100"
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 3 |
|
Date of First Enrollment (India)
|
24/03/2024 |
| 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="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
|
Pregnancy and childbirth predispose women to perineal trauma and pelvic floor dysfunction, resulting
in increased rates of urinary and anal incontinence, perineal pain and sexual dysfunction. Episiotomy
is a surgical procedure that is widely used in our labour rooms to facilitate delivery and prevent such
complications of labor like perineal and anorectal trauma. However, routine episiotomy is now
considered a form of obstetric violence. However, in one French study episiotomy was performed in
68% of first-time mothers and 31% of multiparas. [1] However, as early as the 1980s, the value of
preventive episiotomy was called into question by publications highlighting the increased risk of rectal
and anal sphincter lesions after episiotomy. [2] Recently some studies have suggested that episiotomy
should never be performed, however not adequately proven in randomized controlled trials. [3] FIGO
also endorses the restrictive use of episiotomy, rather than its routine use. The need to reduce
episiotomy rates stems from evidence that episiotomies cause serious perineal lacerations, rather than
prevent them.[4] Routine mediolateral episiotomy (RMLE) decreases the risk of anterior perineal
lacerations, but increases the risk of posterior perineal lacerations, and the need for suturing[5,6]. Even
in the context of shoulder dystocia, episiotomy has not shown to have any clear benefits.[7] There is
some evidence that women with a prior episiotomy have a two-fold increased risk of 2nd degree lacerations in subsequent vaginal deliveries. In addition episiotomy may be associated with a decrease
in pelvic floor musculature strength, more perineal pain, and future dyspareunia, when compared with
spontaneous laceration. The effect of mediolateral episiotomy on obstetric anal sphincter injuries
(OASIS) in spontaneous vaginal deliveries is also not completely clear. Although a recent metaanalysis of observational data concluded that mediolateral episiotomy may reduce the incidence of
OASIS and should not be withheld especially in nulliparous women. In fact after adjusting for
confounding factors, mediolateral episiotomy has shown a significant 2.5 times reduction in
developing lacerations in primiparous women compared with no episiotomy[6]. However, other
studies have shown that episiotomy increases the risk of anal incontinence after vaginal birth by
1.7.[8] A recent study suggested that mediolateral episiotomy is not protective of occurrence of
OASIS, but sample size was small and therefore the study was not powered to provide substantial
clinical conclusions. [9]
The primary aim of this study was to determine the effect of routine episiotomy versus no episiotomy
on perineal lacerations and postpartum pelvic floor outcomes including urinary and anal incontinence
and perineal pain in nulliparous women.
We also aim to assess the effect of obstetrics related perineal injury on novel biomarkers in nulliparous
women. Recent efforts in biomarker research have identified some organ-selective markers that have
sufficient sensitivity to detect organ damage. Some organ specific biomarkers are glial fibrillary acidic
protein for brain injury, kidney injury marker-1 for kidney injury, cardiac troponin for heart damage,
intestinal- type fatty acid binding protein for gut injury, and d-dimer for coagulopathy. They have
shown clinical diagnostic utility to detect injury to individual organs. But the role of biomarkers in
genital injury has not been explored yet.
As a pilot study, we plan to recruit 100 women as per the inclusion and exclusion criteria, 50 each in
routine episiotomy and no episiotomy group and determine the effect of routine episiotomy vrs no
episiotomy on perineal lacerations and postpartum pelvic floor outcomes including urinary and anal
incontinence, sexual function and perineal pain in nulliparous women. Also we will assess the effect
of obstetrics related perineal injury on novel biomarkers in nulliparous women. |