FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/104469 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the role of antibiotics in preventing infection of the wound in private part made at the time of normal vaginal childbirth 
Scientific Title of Study   Prophylactic antibiotics and episiotomy infection rates in women undergoing normal vaginal delivery- A randomized controlled trial 
Trial Acronym  PAIVE trial 
Secondary IDs if Any  
Secondary ID  Identifier 
JIP/IECIS-10/1125/140/ Version 2/ 12.01.2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niranjana K 
Designation  Junior resident in Obstetrics and Gynaecology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Old Blackwell hostel JIPMER campus Dhanvantri Nagar Gorimedu Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7550039433  
Fax    
Email  niranjanakarthikeyan3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gowri Dorairajan 
Designation  Professor Obstetrics and Gynaecology 
Affiliation  JIPMER 
Address  2nd floor Department of Obstetrics and Gynaecology Women and Children Hospital JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9894348518  
Fax    
Email  gowridorai@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gowri Dorairajan 
Designation  Professor Obstetrics and Gynaecology 
Affiliation  JIPMER 
Address  2nd floor Department of Obstetrics and Gynaecology Women and Children Hospital JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9894348518  
Fax    
Email  gowridorai@hotmail.com  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER Campus Road Dhanvantri Nagar Gorimedu Puducherry 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niranjana K  Jawaharlal Institute of Postgraduate Medical Education and Research   2nd floor Department of Obstetrics and Gynaecology Women and Chidren Hospital JIPMER JIPMER Campus Road Dhanvantri Nagar Gorimedu Puducherry 605006
Pondicherry
PONDICHERRY 		 7550039433

niranjanakarthikeyan3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O85||Puerperal sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 single dose of Injection Amoxycillin + clavulanic acid 1.2g will be given intravenously after delivery of the baby at the time of episiotomy suturing in recruited participants. 
Comparator Agent  Standard care at the time of episiotomy suturing in women undergoing normal vaginal delivery. No antibiotic will be given  Recruited participants will receive standard care according to the existing guidelines, following episiotomy. Antibiotic will not be given.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women with singleton pregnancy at term undergoing normal vaginal delivery with episiotomy 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 episiotomy  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 Outcome  
Outcome  TimePoints 
To compare perineal pain in the two groups using Numerical Rating Scale  At 48 hours and 6 weeks post delivery using Numerical Rating Scale 
 
Target Sample Size   Total Sample Size="227"
Sample Size from India="227" 
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   N/A 
Date of First Enrollment (India)   02/03/2026 
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="1"
Months="6"
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   There are very few studies on the usage of prophylactic antibiotics for women undergoing normal vaginal delivery with episiotomy. Asians have a short perineum and episiotomy is preferred by most obstetricians to prevent tears. 
Episiotomy wound infections cause immense physical and psychological stress to the mother, prolonged hospital stay, delayed wound healing, wound dehiscence, chronic pain, dyspareunia and delay and difficulty in resuming normal postpartum activities.
This study aims to determine the role of prophylactic antibiotics (single dose of Injection Amoxycillin+ clavulanic acid 1.2g intravenously administered) at the time of episiotomy suturing in preventing episiotomy wound infections amongst women undergoing normal vaginal delivery. 
 
Close