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Effect of ‘Routine episiotomy’ versus ‘No episiotomy’ on perineal injury and pelvic floor dysfunction during normal vaginal delivery among primigravida women: A Pilot 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 - RENE Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064216
Enrollment
100
Registered
2024-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Routine Episiotomy: Mediolateral episiotomy will be performed using specific episiotomy scissors at the time of crowning during second stage of labour. Local anaesthesia( Injection lido

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Antenatal women admitted in third trimester with singleton pregnancy having cephalic presentation at >34 weeks who are expected to have a normal vaginal delivery

Exclusion criteria

Exclusion criteria: 1. Any contraindication of vaginal delivery 2. Pregnancies with multiple gestations 3. Estimated fetal weight >3 Kg 4. Previous surgery for incontinence and prolapse 5. Women with bleeding disorders/anticoagulation 6. Women with occipito posterior position

Design outcomes

Primary

MeasureTime frame
Grade of perineal injury,Characteristics of suturing,Perineal pain, Urinary retention, Complications of perineal suturing, Symptoms of pelvic floor dysfunction, Clinical assessment of pelvic floor muscle function,Prolapse staging, degree of perineal injury, change in the level of serum biomarkers from baseline among the two groups, postpartum pelvic floor outcomes like anal incontinence, Urinary incontinenceTimepoint: 1.Within 24 hours of delivery 2. At 36 hours after delivery 3. At 3 months after delivery—

Secondary

MeasureTime frame
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/epidural top ups/iv paracetamol/flexon/other analgesics -Parauretheral tears -Need for instrumental delivery 2. At 36 hours after delivery - Need for pain killer/frequency of use of pain killer/epidural top ups/iv paracetamol/flexon/other analgesics 3. At 3 months after delivery - Dyspareunia Timepoint: With in 24 hours after delivery At 36 hours after delivery At 3 months after delivery—

Countries

India

Contacts

Public ContactArchana Kumari

AIIMS, New Delhi

drarchanaaiims0312@gmail.com9868308594

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026