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To study the role of antibiotics in preventing infection of the wound in private part made at the time of normal vaginal childbirth

Prophylactic antibiotics and episiotomy infection rates in women undergoing normal vaginal delivery- A randomized controlled trial - PAIVE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104469
Enrollment
227
Registered
2026-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: O85- Puerperal sepsis

Interventions

Intervention1: Single dose of Injection Amoxycillin+ clavulanic acid 1.2g at the time of episiotomy suturing along with standard care in women undergoing normal vaginal delivery: After test dose, a s

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with singleton pregnancy at term undergoing normal vaginal delivery with episiotomy

Exclusion criteria

Exclusion criteria: Women 1. With prolonged active phase more than 12 hours 2. With intra-partum fever or chorioamnionitis 3. Receiving antibiotics during labor for any reason 4. With obstetric anal sphincter injuries (OASIS) or post partum hemorrhage 5. Who are in an immunocompromised state or receiving immunomodulatory drugs 6. With uncontrolled diabetes

Design outcomes

Primary

MeasureTime frame
To compare the proportion of episiotomy wound infection rates using REEDA score in those receiving and not receiving prophylactic antibiotic amongst women undergoing normal vaginal delivery with episiotomyTimepoint: The episiotomy wound will be assessed using REEDA scale at 48 hours of delivery and the participant will be contacted through phone at 6 weeks post delivery and enquired about pain, occurrence of episiotomy wound dehiscence and need for resuturing.

Secondary

MeasureTime frame
To compare perineal pain in the two groups using Numerical Rating ScaleTimepoint: At 48 hours and 6 weeks post delivery using Numerical Rating Scale

Countries

India

Contacts

Public ContactDr Gowri Dorairajan

JIPMER

gowridorai@hotmail.com9894348518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026