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Study of the impact of delivery without episiotomy among primigravida women

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 - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064111
Enrollment
100
Registered
2024-03-14
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,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 activityTimepoint: 1st With in 24 hours after delivery 2nd At 36 hrs after delivery 3rd At 3 months after delivery

Secondary

MeasureTime frame
DyspareuniaTimepoint: At 3 months after delivery ;Need for pain killer or frequency of use of pain killer or epidural top ups or iv paracetamol or flexon or other analgesicsTimepoint: At 36 hours after delivery;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 deliveryTimepoint: With in 24 hours after delivery

Countries

India

Contacts

Public ContactDr Archana Kumari

All India Institute of Medical Science

drarchanaaiims0312@gmail.com9868308594

Outcome results

None listed

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