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CTRI Number  CTRI/2024/05/067623 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 18/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of drugs Carbetocin and Oxytocin in normal delivery women 
Scientific Title of Study   The efficacy of Intravenous Carbetocin versus Intravenous Oxytocin in active management of Third stage of labour in women delivering vaginally - A randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Kaushal Shah 
Designation  Junior Resident  
Affiliation  Department of Obstetrics and Gynaecology 
Address  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Digdoh Hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India 
Phone  9769890393  
Fax    
Email  shahnidhi9419@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuja Bhalerao  
Designation  Professor and Head of Department  
Affiliation  Department of Obstetrics and Gynaecology 
Address  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Digdoh Hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India 
Phone  9823680572  
Fax    
Email  anuja_bhalerao@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anuja Bhalerao  
Designation  Professor and Head of Department  
Affiliation  Department of Obstetrics and Gynaecology 
Address  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Digdoh Hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India 
Phone  9823680572  
Fax    
Email  anuja_bhalerao@yahoo.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India- 440016  
 
Primary Sponsor  
Name  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Digdoh Hills, Hingna Road, Nagpur, Maharashtra, India-440016  
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 Nidhi Kaushal Shah   NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital  Room No. 2, 3rd Floor, Labour Room, Department of Obstetrics and Gynaecology
Nagpur
MAHARASHTRA 
9769890393

shahnidhi9419@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital  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  Group A: Intravenous Carbetocin which is a long-acting synthetic agonist analogue of human oxytocin.   Dose: 100 mcg; Frequency: Once; Route of administration: Intravenous with slow bolus method; Onset of action: 2 minutes; Duration of action: 2-4 hours after intravenous injection 
Comparator Agent  Group B: Intravenous Oxytocin which indirectly stimulates the contraction of uterine smooth muscle by increasing the sodium permeability of uterine myofibrils.  Dose: 10 IU IM or 5-10 IU; Frequency: Once; Route of administration: slow Intravenous injection; Onset of action: 2-3 mins; Duration of action: 15-20 mins 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Women with a singleton-term pregnancy undergoing vaginal delivery. 
 
ExclusionCriteria 
Details  1. Hypertensive disorders in pregnancy
2. Moderate anemia (Hemoglobin less than 9gm per dl)
3. Placental abruption (determined by history and ultrasound report)
4. Placenta previa
5. Polyhydramnios
6. Grand Multipara
7. Known case of cardiac disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Quantitative measure of blood loss during the third stage of labor.
2. Hemoglobin level 
Immediately post delivery and on day 3 post delivery. 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
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 2 
Date of First Enrollment (India)   30/05/2024 
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="6"
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 - NO
Brief Summary  

Introduction: Active management of the third stage of labor (AMTSL) is a critical intervention for Postpartum hemorrhage (PPH) prevention which is commonly caused by uterine atony. The current standard therapy for the prevention of PPH is oxytocin but it presents unsatisfactory real-world efficacy because of its sensitivity to heat and insufficient active ingredients or impurities, however, an oxytocin analog heat-stable carbetocin  does not require cold-chain transport and storage. Therefore, this study aims to determine the efficacy of Intravenous (IV) carbetocin in the AMTSL in vaginal deliveries.

Methodology: A total of 184 antenatal women will be randomized by computer-generated randomization and a sequentially numbered, sealed opaque envelope method will be used for allocation in this single-blinded parallel-group randomized controlled trial. Group A (study group) will receive an injection of carbetocin 100 mcg IV slow bolus as a single dose and Group B (control group) will receive 10 IU IV infusion of oxytocin after the delivery of the baby within 1 minute and before the delivery of the placenta.

Result: The blood loss in each group will be calculated using a quantitative method of measuring blood loss. The use of other uterotonics to prevent PPH will be taken into account. The patient’s hemoglobin and need for blood transfusion will be noted on day 3 following the vaginal delivery. The statistical analysis will include descriptive and inferential analysis to determine the significant difference.

Conclusion: The present study will be comparing and concluding the efficacy of IV carbetocin with IV oxytocin in the AMTSL and PPH in vaginal deliveries. This will explore the implication of a much more effective drug that will assist in the prevention of PPH and reduce mortality and morbidity during vaginal deliveries.

 
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