| CTRI Number |
CTRI/2024/08/071777 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study Of Oxytocin versus Carbetocin In Decreasing Intraoperative Bleeding During Cesarean Section |
|
Scientific Title of Study
|
A comparative study of oxytocin versus carbetocin in reducing intraoperative bleeding during 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 |
DR VINIT DHANURE |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institution Of Higher Education And Research |
| Address |
Department Of Anesthesia, Jawaharlal Nehru Medical College, Sawangi(Meghe),Wardha ,Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
7709825375 |
| Fax |
|
| Email |
dhanure.vinit95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIKHIL BHALERAO |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institution Of Higher Education And Research |
| Address |
Department Of Anesthesia, Jawaharlal Nehru Medical College, Sawangi(Meghe),Wardha ,Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
9960556290 |
| Fax |
|
| Email |
docnics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VINIT DHANURE |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institution Of Higher Education And Research |
| Address |
Department Of Anesthesia, Jawaharlal Nehru Medical College, Sawangi(Meghe),Wardha ,Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
7709825375 |
| Fax |
|
| Email |
dhanure.vinit95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College And Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of Anesthesia Of Datta Meghe Institute Of Higher Education And Research |
| 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 |
| Vinit Dhanure |
Jawaharlal Nehru Medical College |
Department Of Anesthesia
Wardha
MAHARASHTRA |
7709825375
dhanure.vinit95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O679||Intrapartum hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CARBETOCIN |
IV 100 mcg given bolus over 1 minute followed by 1.5 ml distilled water in 500 ml normal saline drip |
| Comparator Agent |
OXYTOCIN |
IV bolus 5 IU over 1 minute, followed by 15 IU in 500 ml Normal saline drip |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients with age between 18-35 years Females.
2)Patients with ASA grade I, II.
3)Patient posted for cesarean section under spinal anesthesia.
4)Singleton pregnancy
5)Term gestation
6)Decision made for a cesarean section in labor
7)Who have given consent |
|
| ExclusionCriteria |
| Details |
1)Patients with ASA grade III, IV.
2)Women with known coagulopathy
3)Study drug hypersensitivity
4)Olygohydromnios or polyhydromnios
5)Cardiac disease (including dysarythmia)
6)Hypertension
7)Liver, renal or endocrine disease (except gestational diabetes)
8)Uterine fibroids or suspicion of placental pathology (accreta, previa or abruptio) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Carbetocin Is More Effective As Compared To Oxytocin In Reducing Intraoperative Bleeding During Cesarean Section |
3 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The use of Carbetocin reduces the requirement for additional uterotonics and surgical maneuvers during cesarean sections in preventing uterine atony and intraoperative hemorrhage. |
3 Years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="5"
Days="30" |
|
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 most common cause of postpartum hemorrhage is uterine atony, which results from poor contraction of the uterus after childbirth. The incidence of postpartum hemorrhage has been increasing in developed countries including the USA and Europe for the past 15 years. Currently, the World Health Organization (WHO)recommends active management of the third stage of labor for prevention of postpartum hemorrhage. Prophylactic administration of uterotonic agents is identified as the most important component of active management of the third stage of labor, which has reduced the incidence of postpartum hemorrhage nearly by 50%. Oxytocin, which has a short half-life and duration of action, is the current standard therapy for the prevention of postpartum hemorrhage. However, as it is susceptible to heat, its efficacy cannot be assured in many low and middle countries where access to cold-chain transport and storage is unavailable, and quality issues such as impurity and insufficient active ingredients also compromise its efficacy. In contrast, carbetocin, which is a long-acting oxytocin analogue, has been widely used in preventing postpartum hemorrhage since 1997, and heat-stable carbetocin, and has been shown to maintain active for more than 36 months at 30°C and 75% relative humidity" Postpartum hemorrhage is a major cause of maternal mortality and morbidity. commonly due to uterine atony prophylactic oxytocin use during cesarean section is recommended; patients with high risk of postpartum hemorrhage intraoperatively may require additional uterotonics. systematic review showed that carbetocin was more effective than oxytocin for reducing the need for additional uterotonic drugs and the need for uterine massage after cesarean delivery. Therefore, we found it necessary to evaluate the efficacy of carbetocin in preventing intraoperative hemorrhage in women undergoing cesarean section compared with oxytocin. This study will also compare the requirement for additional uterotonics and requirement of antifibrinolytics and the time required for surgery in two different groups |