| 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
|
|
|
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
|
|
|
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. |