| CTRI Number |
CTRI/2023/03/050426 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of Oxytocin and
Carbetocin for the prevention of postpartum haemorrhage in high risk patients undergoing cesarean delivery |
|
Scientific Title of Study
|
A comparison of Oxytocin and Carbetocin for the prevention of postpartum haemorrhage in high risk patients undergoing cesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vrinda Oza |
| Designation |
Assisstant Professor |
| Affiliation |
PDU Govt Medical College,Rajkot |
| Address |
Department of Anaesthesiology,
PDU Govt Medical College,
Rajkot 360001
Department of Anaesthesiology,
PDU Govt Medical College,
Rajkot 360001
Rajkot
GUJARAT
360001
India |
| Phone |
9228099479 |
| Fax |
|
| Email |
vrinda.agravat@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalrav Rawal |
| Designation |
Resident Doctor |
| Affiliation |
PDU Govt Medical College,Rajkot |
| Address |
D35, Doctor quarters, High rise building, Jamtower chowk, Jamnagar road, Rajkot 360001
D35, Doctor quarters, High rise building, Jamtower chowk, Jamnagar road, Rajkot 360001
Rajkot
GUJARAT
360001
India |
| Phone |
9016055443 |
| Fax |
|
| Email |
kalravrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalrav Rawal |
| Designation |
Resident Doctor |
| Affiliation |
PDU Govt Medical College,Rajkot |
| Address |
D35, Doctor quarters, High rise building, Jamtower chowk, Jamnagar road, Rajkot 360001
D35, Doctor quarters, High rise building, Jamtower chowk, Jamnagar road, Rajkot 360001
Rajkot
GUJARAT
360001
India |
| Phone |
9016055443 |
| Fax |
|
| Email |
kalravrawal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PDU Govt Medical College Rajkot |
| Address |
PDU Govt Medical College Rajkot,
Jamnagar road, Rajkot 360001 |
| Type of Sponsor |
Government 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 Kalrav Rawal |
PDU Govt Medical College Rajkot |
Department of Anaesthesiology,
PDU Govt Medical College Rajkot,
Rajkot 360001
Rajkot
GUJARAT |
9016055443
kalravrawal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE OF PDU GOVT MEDICAL COLLEGE,RAJKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
High risk pregnant female patients posted for elective cesarean delivery of ASA grade III and IV aged between 18 and 40 years with 35-40 weeks of gestation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carbetocin |
Carbetocin 100 mcg single i.v. bolus would be given over 1 minute on delivery of the foetus and the clamping of the umbilical cord. |
| Comparator Agent |
Oxytocin |
Oxytocin 20IU in 1000ml NaCl(0.9%) @ 150ml/hr would be given after the delivery of the foetus and clamping of the umbilical cord. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
High risk pregnant patients posted for elective cesarean delivery under spinal anaesthesia of ASA Grade III and IV with 35-40 weeks of gestation, Multiple pregnancies, Previous cesarean scar, Presence of uterine fibroids, Previous myomectomy, Presence of placenta previa, Past history of PPH |
|
| ExclusionCriteria |
| Details |
Hypertension, Preeclampsia, Cardiac diseases, Renal diseases, Liver diseases, Epilepsy, Neuromuscular diseases, Severe anemia, General Anaesthesia, Women with history of hypersensitivity to carbetocin/oxytocin, Patient refusal |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Oxytocin and Carbetocin in terms of intraoperative blood loss, additional uterotonic needed and adverse effects if any in caesarean delivery with high risk of post-partum haemorrhage. To compare the hemodynamic effects of Oxytocin and Carbetocin (effects on heart rate and blood pressure)
|
Heart rate and blood pressure noted before skin incision, after 1 minute, 3 minutes, 5 minutes, at the time of skin closure, after 2 hours, after 12 hours. Uterine tone noted at time of delivery and after 3 minutes, 6 minutes, 9 minutes, 12 minutes, 2 hours, 12 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Demographic data
2)Uterine tone
3)Additional uterotonic used
4)Additional side effects |
1)Maternal Age(years) and Gestational Age(weeks)
2)Likert Scale at time of delivery, after 3 minutes, after 6 minutes, after 9 minutes, after 12 minutes after 2 hours, after 12 hours(Likert scale 0-4, 0-floppy,1-soft, 2-poorly contracted, 3-well contracted, 4-hard rock)
3)Additional uterotonics used
4)Nausea, Vomitting, Flushing, Tachycardia, Hypotension, Headache, Chestpain
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/04/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post partum hemorrhage(PPH) is still a major cause of maternal morbidity and mortality. PPH is responsible for majority of maternal mortality in India and globally. There have been few studies/literature of effectiveness of carbetocin for the prevention of PPH following cesarean delivery, hence we decided to do a prospective study comparing prophylactic administration of oxytocin and carbetocin and to study its efficacy in prevention of PPH in high-risk females undergoing cesarean delivery.
|