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CTRI Number  CTRI/2024/04/065764 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 14/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Efficacy of earlier IV oxytocin during primary c section ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Early iv oxytocin during emergency caeserean section in decreasing blood loss 
Scientific Title of Study   A Randomised control trial of Efficacy of early IV oxytocin infusion at the time of Abdominal skin incision in decreasing blood loss in emergency primary caesarean section 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BHACKIYA  
Designation  JUNIOR RESIDENT  
Affiliation  Government Thanjavur Medical college and hospital  
Address  Department of Obstetrics and Gynaecology Thanjavur medical College Thanjavur
Government Thanjavur medical College and hospital Thanjavur 613004
Thanjavur
TAMIL NADU
613004
India 
Phone  9943987484  
Fax    
Email  a.bhackiya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Raji 
Designation  Associate professor  
Affiliation  Government Thanjavur Medical college and hospital  
Address  Department of Obstetrics and gynaecology Thanjavur medical College and hospital Thanjavur
Government Thanjavur medical College and hospital Thanjavur 613004
Thanjavur
TAMIL NADU
613004
India 
Phone  9894616469  
Fax    
Email  rajidr_2003@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  BHACKIYA  
Designation  JUNIOR RESIDENT  
Affiliation  Government Thanjavur Medical college and hospital  
Address  Department of Obstetrics and gynaecology Thanjavur medical College and hospital Thanjavur
Government Thanjavur medical College and hospital Thanjavur 613004

TAMIL NADU
613004
India 
Phone  9943987484  
Fax    
Email  a.bhackiya@gmail.com  
 
Source of Monetary or Material Support  
Thanjavur medical College and hospital  
 
Primary Sponsor  
Name  DrBHACKIYA  
Address  Department of Obstetrics and gynaecology Govt Thanjavur medical College and hospital Thanjavur 613004 Tamilnadu India . 
Type of Sponsor  Other [] 
 
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 BHACKIYA   Govt Raja mirasudhar hospital   Department of Obstetrics and gynaecology Govt Raja mira sudhar hospital Thanjavur medical College Thanjavur 613001
Thanjavur
TAMIL NADU 		 9943987484

a.bhackiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Thanjavur medical College institutional Ethical committee for Human studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O721||Other immediate postpartum hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oxytocin infusion  oxytocin 10 Units in 200ml of Ringer lactate intravenous infusion over 15 mins 250drops 
Comparator Agent  Oxytocin injection   oxytocin 10units intramuscular one time after delivery of fetus  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Primi Singleton Pregnancy with 37 completed weeks of gestation taken up for Emergency primary caeserean section

2.Multiparous women with previous normal vaginal delivery / previous instrumental deliveries with 37 completed weeks of gestation who are taken up for Emergency Primary caesarean section 
 
ExclusionCriteria 
Details  Obesity
,Heart disease,
Gestational Hypertension,
Gestational Diabetes mellitus on Insulin,
Previous LSCS
,Previous Myomectomy
,Previous Laparotomy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate The Efficacy Of Early Iv Oxytocin Infusion In Primary Caeserean Section In Reduction Of Intraoperative And Post Operative Blood Loss And In Reduction Of Usage Additional Uterotonics
  		 5 months 
 
Secondary Outcome  
Outcome  TimePoints 
In This Study Intraoperative And Post Operative Haemorrhage Can Be Reduced And Hence Maternal Mortality Due To Pph Can Be Reduced  2 years 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   Phase 3 
Date of First Enrollment (India)   01/05/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [a.bhackiya@gmail.com].

  6. For how long will this data be available start date provided 26-06-2025 and end date provided 26-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Aim of this  randomised control trial is to evaluate the efficacy of early iv oxytocin infusion that is at the time of abdominal skin incision in emergency primary c section which reduces intraop and postoperative blood loss and additional uterotonic usage and blood transfusion and in reducing the maternal mortality rate by postpartum haemorrhage  
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