| 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
|
|
|
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
|
|
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. |