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CTRI Number  CTRI/2024/02/062831 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A0 study to assess safety and effectiveness of carbetocin vs oxytocin after delivery of baby in cesarean section to prevent excessive bleeding 
Scientific Title of Study   A double blinded randomized controlled study to assess safety and effectiveness of carbetocin vs oxytocin during active management of third stage, for prevention of PPH in patients undergoing cesarean 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  RAJANI SOMANATHAN 
Designation  Assistant Professor  
Affiliation  siddaganga medical college and research institute 
Address  Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute, Tumkur, Karnataka

Tumkur
KARNATAKA
572101
India 
Phone  8606605516  
Fax    
Email  kuttu2412@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RAJANI SOMANATHAN 
Designation  ASSISTANT PROFESSOR 
Affiliation  siddaganga medical college and research institute 
Address  Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute, Tumkur, Karnataka

Tumkur
KARNATAKA
572101
India 
Phone  8606605516  
Fax    
Email  kuttu2412@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RAJANI SOMANATHAN 
Designation  ASSISTANT PROFESSOR 
Affiliation  siddaganga medical college and research institute 
Address  Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute, Tumkur, Karnataka

Tumkur
KARNATAKA
572101
India 
Phone  8606605516  
Fax    
Email  kuttu2412@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology, SIDDAGANGA medical college and research institute, Tumkur, Karnataka  
 
Primary Sponsor  
Name  siddaganga medical college and research institute 
Address  Siddaganga medical college and research institute Tumkur, karnataka 572101 
Type of Sponsor  Private medical college 
 
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 S RAJANI   SIDDAGANGA MEDICAL COLLEGE AND RESEARCH INSTITUTE  Room number 1,Out patient department, Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute, Tumkur, Karnataka 572101
Tumkur
KARNATAKA 
8606605516

kuttu2412@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Siddaganga Medical College and Research Institute, Tumakuru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CARBETOCIN   100mcg of IV Carbetocin slowly over one minute, during active management of third stage of labour. Blood loss, need for additional uterotonics ,side effects will be noted for the next 24 hours. 
Comparator Agent  OXYTOCIN  10 Units of oxytocin slow IV during active management of third stage of labour.Blood loss, need for additional uterotonics, side effects will be noted for the next 24 hours. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  willing to participate
gestational age 36 weeks-41 weeks
patients undergoing cesarean section 
 
ExclusionCriteria 
Details  hypertensive
pre eclampsia
eclampsia
ante partum hemorrhage
bleeding disorders
thrombocytopenia
blood coagulation abnormalities
cardiovascular disorders
epilepsy
asthma
migraine
renal disease
liver disease
general anesthesia
retained placenta
placenta accreta
placenta previa
previous pph
grand multipara
fibroid with pregnancy
prolonged labour
hypersensitivity to oxytocin or carbetocin
traumatic pph 
 
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 
TO compare the safety and efficacy of carbetocin with oxytocin to prevent PPH during active management of third stage of labour.  blood loss assesment intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the requirement for additional uterotonics in both groups  need for additional uterotonics assesed intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour. 
To compare adverse effects among both groups.  adverse effects noted intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour. 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 4 
Date of First Enrollment (India)   27/02/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

“ The American College of Obstetricians and Gynecologists (ACOG) defines PPH as blood loss of more than or equal to 1000 ml, or blood loss that was accompanied by signs or symptoms of hypovolemia occurring within 24 h after birth, regardless of the mode of delivery”1

PPH  is the leading cause of maternal mortalityÙ°,currently accounting  for approximately 25% of pregnancy-associated deaths worldwide.80% of PPH is due to uterine atonicity which is preventable.Active management of the third stage of labor(AMTSL) is done to prevent atonic PPH.This involves the use of interventions (including the use of uterotonics, early clamping of the umbilical cord and controlled cord traction). Uterotonics are oxytocin, methyl ergometrine, carbetocin, carboprost and misoprostol.2

Carbetocin is a heat stable analogue of oxytocin with a longer half life. WHO and FIGO recommends the use of oxytocin (10 IU, IM/IV) for the prevention of PPH for all births.The use of carbetocin (100 μg, IM/IV) is recommended for the prevention of PPH for all births in contexts where its cost is comparable to other effective uterotonics, and also in settings where oxytocin is unavailable (or its quality cannot be guaranteed).1,3

Our study aims to compare the effectiveness of oxytocin vs carbetocin in the active management of the third stage of labor among patients undergoing LSCS in a tertiary care centre by a randomized controlled double blinded study.

240 Antenatal women who are admitted for safe confinement and fulfilling the inclusion and exclusion criteria and giving informed written will be  enrolled  for the study.

Routine obstetric examination and investigations will be done.

Randomisation will be done by the sealed opaque envelope method.240 randomly generated treatment allocations within sealed opaque envelopes into either group A (OXYTOCIN 10 IU IV) or Group B(Carbetocin 100 mcg IV)  will be placed in the OT in a box. In the Operation theater,the Anesthetist will take one of the envelopes and open it and the drug as per the group alloted will be loaded in the syringe.If general anesthesia is required, she will be excluded from the study.Under regional anesthesia, under aseptic precautions , LSCS will be done.

Immediately after the delivery of the baby,AMTSL will be done.Either 100mcg of IV carbetocin slowly over a minute or 10 units of oxytocin slow  IV as per the group allotted will be administered.

Once the uterus is well contracted, Uterus will be closed in a single layer with non interlocking sutures using no 1 vicryl.

If uterine atonicity is  noted at any point during the intraoperative or postpartum period, additional oxytocics will be given as per need. The doses of these required will be recorded.Surgical methods of control of PPH will be resorted to if required.Any instances of  traumatic PPH  will be excluded from the study.

Blood loss will be assessed by: A+B-C11

A. The difference in the dry and wet weight of the steripads,mops, packs used.1gm of difference will be considered as 1 ml of blood loss.

B.The volume of the suction bottle.(ml)

C.Amniotic fluid volume in ml.(AFI X 30)

The vitals will be  assessed immediately following delivery of the baby  and then hourly for 2 hours.

The subject will be  assessed for adverse effects of metallic taste, fever, nausea, vomiting, headache, raise/fall  in Blood Pressure, shivering, diarrhoea.Any other adverse reactions will be noted.Monitoring will be continued 6 th hourly for the first 24 hrs.

Hb will be reassessed on post operative day 3 and recorded. The difference in the pre op and postoperative Hb will be noted.

 Patient will be  discharged on post operative day 4 if stable.

 The details filled in the proforma will be statistically analyzed to reach a conclusion at the end of the study period.

 
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