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CTRI Number  CTRI/2024/04/065975 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing Carbetocin and oxytocin for prevention of post partum hemorrhage following vaginal delivery 
Scientific Title of Study   Carbetocin versus oxytocin in the prevention of atonic postpartum hemorrhage following normal vaginal delivery - An interventional study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kondamudi Saranya 
Designation  junior resident 
Affiliation  AIIMS Mangalagiri 
Address  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,OPD BLOCK,ROOM NO:305,AIIMS MANGALAGIRI

Guntur
ANDHRA PRADESH
522501
India 
Phone  9493550788  
Fax    
Email  Kondamudisaru72@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kondamudi Saranya 
Designation  junior resident 
Affiliation  AIIMS Mangalagiri 
Address  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,OPD BLOCK,ROOM NO:305,AIIMS MANGALAGIRI

Guntur
ANDHRA PRADESH
522501
India 
Phone  9493550788  
Fax    
Email  Kondamudisaru72@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharmila V 
Designation  Professor and Head of the department 
Affiliation  AIIMS Mangalagiri 
Address  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,OPD BLOCK,ROOM NO:305,AIIMS MANGALAGIRI

Guntur
ANDHRA PRADESH
522501
India 
Phone  98437763667  
Fax    
Email  sharu_jipmer@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr Saranya (PI) 
 
Primary Sponsor  
Name  Dr.Saranya,Postgraduate in Obstetrics and gynaecology 
Address  AIIMS MANGALAGIRI 
Type of Sponsor  Other [Self funding(PI)] 
 
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 Saranya Kondamudi  AIIMS Mangalagiri  Department of Obstetrics and Gynaecology,OPD BLOCK ROOM NO.305 ,AIIMS Mangalagiri
Guntur
ANDHRA PRADESH 		 9493550788

Kondamudisaru72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Carbetocin  Injection Carbetocin 100 mcg in 9 ml of Normal Saline slow I.V  
Comparator Agent  Oxytocin  Injection Oxytocin 10 IU in Ringer lactate I.V Infusion  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women in age group 18-35 years
1. Singleton pregnancy
2. Term (37-42 weeks of gestation)
3. Women who undergo vaginal delivery
4. Patients willing to give informed consent 
 
ExclusionCriteria 
Details  High risk pregnant women including: antepartum hemorrhage- placenta previa, abruptio
placentae, preeclampsia, eclampsia, GDM A2, multiple pregnancies, post cesarean
pregnancy, polyhydramnios, macrosomia, patients with gynecological disorders such as
myomas
● Medical disorders: coagulation disorders, thrombocytopenia (platelets <1.5 lakh), renal
disorders, hepatic disorders, heart disease, asthma, epilepsy, women with HIV
● Intellectual challenged women
● Known allergy to carbetocin
● Patients not willing to sign informed consent. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Uterine tone and vaginal bleeding immediately and at 1, 2, 3 hours post delivery in both the
groups
1.Estimated blood loss (ml) and PPH (blood loss 500 ml) in both study groups

2. Need for use of additional uterotonic drugs and/or blood transfusion in both the groups 		 1-3 Days after Randomization
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in value of hemoglobin, Hematocrit and Packed cell volume (PCV)Pre and 24 -hour
post-delivery in both the groups
● Drug related adverse effects such as nausea, vomiting, shivering, headache, anaphylaxis in
both the groups 		 1-3 Days after Randomization 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/06/2024 
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   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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  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 [Kondamudisaru72@gmail.com].

  6. For how long will this data be available start date provided 08-01-2026 and end date provided 08-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The most important step in the active management of third stage of labour is the use of uterotonic agent.conventionally we have been using oxytocin as the uterotonic agent.however it has to be kept under refrigeration during transport and storage for maintaining its potency.carbetocin is an oxytocin analogue which doesnot require refrigeration.In our study we aim to compare the efficacy of both these agents in the prevention of atonic postpartum hemorrhage following normal vaginal delivery. 
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