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CTRI Number  CTRI/2015/10/006329 [Registered on: 29/10/2015] Trial Registered Retrospectively
Last Modified On: 10/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Additional injection to prevent infection after cesearean delivery 
Scientific Title of Study   Randomized double blinded controlled trial to compare the efficacy of Extended spectrum antibiotics with narrow spectrum antibiotic as prophylaxis in Cesarean delivery for the prevention of post Cesarean endometritis. 
Trial Acronym  PACS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSivasankari 
Designation  PG Registrar 
Affiliation  Christian medical college 
Address  Unit 4 Department of Obstetrics Christian medical college Vellore
Department of Obstetrics and Gynaecology Christian medical college vellore
Vellore
TAMIL NADU
632004
India 
Phone  9843444619  
Fax    
Email  dsankari5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRuby Jose 
Designation  HOD 
Affiliation  Christian medical college 
Address  Unit 4 Department of Obstetrics Christian medical college Vellore
Department of Obstetrics and Gynaecology Christian medical college vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162286185  
Fax    
Email  rubyjose1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSivasankari 
Designation  PG Registrar 
Affiliation  Christian medical college 
Address  Unit 4 Department of Obstetrics Christian medical college Vellore
Department of Obstetrics and Gynaecology Christian medical college vellore
Vellore
TAMIL NADU
632004
India 
Phone  9843444619  
Fax    
Email  dsankari5@gmail.com  
 
Source of Monetary or Material Support  
internal-applying for fluid research fund from Christian medical college hospital,vellore 
 
Primary Sponsor  
Name  internal fluid research 
Address  christian medical college 
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 
Sivasankari  Christian medical college ,vellore  Labour room and antenatal ward in the department of obstetric and gynaecology
Vellore
TAMIL NADU 
9843444619

dsankari5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, Pregnant women completed 37 weeks undergoing cesarean section,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  injection azithromycin 500 mg in 250ml NS intravenous single dose over 1 hr  injection azithromycin 500 mg in 250ml NS intravenoue over 1 hr single dose with injection cefazolin 1 gm intravenous single dose 
Comparator Agent  injection cefazolin 1 gm intravenous  injection cefazolin 1 gm and placebo intravenous 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  pregnant women with completed 37 weeks undergoing cesarean section  
 
ExclusionCriteria 
Details  Patients with known allergy to Cephalosporin and Azithromycin
Patient who have received antibiotics within a week prior to the delivery or intrapartum propylaxis for chorioamnionitis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
endometritis until 42days post operative
surgical site infection until 42days postoperative
urinary tract infection until 42days postoperative
length of hospital stay attributed to mothers illness .At the end of 42 days postoperative ,patient will reassed 
endometritis until 42days post operative
surgical site infection until 42days postoperative
urinary tract infection until 42days postoperative
length of hospital stay attributed to mothers illness .At the end of 42 days postoperative ,patient will reassed 
 
Secondary Outcome  
Outcome  TimePoints 
anaphylactic reactions
number of readmisions until 6 weeks postoperative
maternal death due to sepsis or other causes until 6 weeks postoperative 
6 weeks postoperative 
 
Target Sample Size   Total Sample Size="1996"
Sample Size from India="1996" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="2000" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   24/02/2015 
Date of Study Completion (India) 30/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1. Priyankur Roy, Bivas Biswas, Siva Sankari, Marie Therese Manipadam, and Ruby Jose. Primary Granulocytic Sarcoma of Ovary J Obstet Gynaecol India. Dec 2012; 62(Suppl 1): 91–93.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Cesarean delivery (CD) are the  most  commonly performed  surgical  procedure  worldwide . According to Cochrane Database Systematic Review in 2002 endometritis is the most frequent post Cesarean complication classically reported in upto 50% of patients . Cesarean  delivery  is associated  with  a  significantly  higher  post-operative  infections such as  surgical  site infection,  urinary  tract  infection (SSI,UTI) and uterine infection   rate  when compared to following  vaginal  birth and  instrumental deliveries .In the present era due to increasing number of Cesarean deliveries  infections are  likely to become a significant health  and  economic  burden .

 

       Post–Cesarean  delivery  endometritis  is   generally  believed  to  have  a  polymicrobial etiology  resulting from  ascension  of  bacteria  from  the  lower  to  the  upper  genital  tract. There  is overwhelming  evidence  that  antibiotic  prophylaxis  for  cesearean  delivery   is  effective in  preventive  maternal  infectious  morbidity.

 

        Cefazolin was used as prophylaxis after cord clamping based on evidence of National institute for Health and Care Excellence (NICE) guidelines 2011 .Based on a study done in CMCH and The Society of Obstetricians and Gynaecologists of Canada( SOGC) 2010, this was changed to using Cefazolin 15-30 minutes prior to skin incision in order to decrease the surgical site infection.

 

        The  association between  ureaplasm  urealyticum  colonization  of  the  chorioamnion  at  Cesarean  delivery (CD) and  an  increased  risk  of  post – Cesarean  delivery  endometritis   occurred  despite  the routine  use  of  intraoperative  prophylactic  antibiotics .  When  these  organisms  are detected , there  is  a  3-8  fold  increased  risk of  endometritis  or  wound  infection  post Cesarean  delivery.

 

          Broad-spectrum  antibiotics when used, were  associated  with  a  statistically  significant reduction  in  endometritis  and  wound  infection  compared  to  narrow-spectrum antibiotics . Length  of  hospital  stay  was  significantly  shorter  when  broad-spectrum antibiotics  were  used.  The  leading  option  as  a  second-line  broad-spectrum  antibiotic for  Cesarean  delivery  appears  to  be  Azithromycin,  which  has  a  longer  half-life  (68 hours) , higher  tissue  concentrations  and  lower  transplacental  passage  than  several other  antibiotics  commonly  used  for  this  indication.  In  addition,  azithromycin  is  active  against  both  aerobes  and  anaerobes,  as  well  as Ureaplasmas,  resulting  in significantly  less  endometritis  and  wound  infection  than  in  studies  in  which  other antibiotics  were  used.

 

 

     In the present study we  aim  to  compare  the following outcome measures in the mother such as surgical site infection , endometritis , UTI  &  serious infections  . The  duration  of  hospital stay  in  mothers  will  be   looked  at.

 
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