FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/044547 [Registered on: 01/08/2022] Trial Registered Prospectively
Last Modified On: 30/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Randomised control trial to look at antibiotic prophylaxis in operative vaginal delivery. 
Scientific Title of Study   Antibiotic prophylaxis in operative vaginal delivery: a Randomized double blind placebo Control Trial in a low resource setting 
Trial Acronym  APOD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anne George Cherian 
Designation  Professor (OG) 
Affiliation  Christian Medical College and Hospital, Vellore 
Address  Department of Community Health, Christian Medical College, Vellore. 632 002

Vellore
TAMIL NADU
632002
India 
Phone  04162284207  
Fax    
Email  annegc97@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Anne George Cherian 
Designation  Professor (OG) 
Affiliation  Christian Medical College and Hospital, Vellore 
Address  Department of Community Health, Christian Medical College, Vellore. 632 002

Vellore
TAMIL NADU
632002
India 
Phone  04162284207  
Fax    
Email  annegc97@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Anne George Cherian 
Designation  Professor (OG) 
Affiliation  Christian Medical College and Hospital, Vellore 
Address  Department of Community Health, Christian Medical College, Vellore. 632 002

Vellore
TAMIL NADU
632002
India 
Phone  04162284207  
Fax    
Email  annegc97@yahoo.co.in  
 
Source of Monetary or Material Support  
Christian Medical College and Hospital 
 
Primary Sponsor  
Name  Christian Medical College and Hospital Vellore 
Address  Christian Medical College and Hospital, Vellore, Tamil Nadu 
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 
Anne George Cherian  Community Health and Development (CHAD) Hospital  Department of Community Health, Christian Medical College and Hospital, Vellore, Tamil Nadu
Vellore
TAMIL NADU 		 04162284207

annegc97@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Christian Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O860||Infection of obstetric surgical wound, (2) ICD-10 Condition: O861||Other infection of genital tract following delivery, (3) ICD-10 Condition: O85||Puerperal sepsis, (4) ICD-10 Condition: O864||Pyrexia of unknown origin following delivery, (5) ICD-10 Condition: O862||Urinary tract infection followingdelivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  amoxicillin-clavulanic acid (1gm/200mg)  Single dose of intravenous (IV) amoxicillin-clavulanic acid (1gm/200mg) within 6 hours of delivery. 
Comparator Agent  Normal saline  Single dose administered as placebo 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Women aged 16 years or above, willing and able to give informed consent.

2.Women who have had an operative vaginal delivery at 36+0 completed weeks or greater gestation.
 
 
ExclusionCriteria 
Details  1.Clinical indication for continuation of antibiotic administration post-delivery
2.Known allergy to penicillin or to any of the components of co-amoxiclav, as previously identified
3.History of anaphylaxis to another β-lactam agent (e.g. cephalosporin, carbapenem or monobactam)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Confirmed or suspected maternal infection
 		 Any time within 6 weeks of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Need for additional pain relief
2. Days of hospitalization
3. Ability to sit comfortably and feed the baby (VAS)
4. Number of hospital visits in the first 6 weeks
5. Number of readmissions
6. Quality of life score
 		 Within 6 weeks post partum 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
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)   01/08/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study aims to look at the use of single dose prophylactic antibiotic in preventing infections in women undergoing operative vaginal deliveries. This study will be a double blinded randomised control trial carried out among women undergoing operative vaginal deliveries. Eligible women will be randomized into interventional arm which will receive a single dose of Amoxycillin clavulanic acid and a placebo arm which will receive normal saline. Primary outcomes studied will include evidence of new onset confirmed or suspected infection within 6 weeks postpartum as evidenced by a new prescription for antibiotic for perineal wound related infection, endometritis, urinary tract infection or sepsis. Secondary outcomes will include perineal pain, health related quality of life, need for hospital visits or readmission and breastfeeding. 
Close