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

Not Applicable

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

• Registration Number: CTRI/2024/03/064216
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>2. At 36 hours after delivery <br/ ><br>3. At 3 months after delivery

Secondary Outcome Measures

Name	Time	Method
With in 24 hours after delivery <br/ ><br>- Duration of second stage of labour <br/ ><br>-Perineal pain and childbirth experience on Visual Analogue Scale <br/ ><br>-Need for pain killer/frequency of use of pain killer/epidural top ups/iv paracetamol/flexon/other analgesics <br/ ><br>-Parauretheral tears <br/ ><br>-Need for instrumental delivery <br/ ><br>2. At 36 hours after delivery <br/ ><br>- Need for pain killer/frequency of use of pain killer/epidural top ups/iv paracetamol/flexon/other analgesics <br/ ><br>3. At 3 months after delivery <br/ ><br>- Dyspareunia <br/ ><br>Timepoint: With in 24 hours after delivery <br/ ><br>At 36 hours after delivery <br/ ><br>At 3 months after delivery