| CTRI Number |
CTRI/2023/09/057333 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
10/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of uterotonic agents in the prevention of post partum haemorrhage following vaginal delivery |
|
Scientific Title of Study
|
Comparative study of Carbetocin vs Oxytocin in the prevention of post partum haemorrhage following vaginal delivery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revathi Mallikarjuna |
| Designation |
Post graduate |
| Affiliation |
Ramaiah Medical College and teaching hospital |
| Address |
Ramaiah medical college and hospital
Junior resident, department of OBG
Mathikere, msr nagar, Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9480708128 |
| Fax |
|
| Email |
revathi8205@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mamatha |
| Designation |
Assistant professor |
| Affiliation |
Ramaiah Medical College and teaching hospital |
| Address |
Ramaiah medical college and teaching hospital, department of OBG
Bangalore KARNATAKA 560054 India |
| Phone |
9535208686 |
| Fax |
|
| Email |
mamatha750@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Revathi Mallikarjuna |
| Designation |
Post graduate |
| Affiliation |
Ramaiah Medical College and teaching hospital |
| Address |
Junior resident, Ramaiah medical college and teaching hospital, department of OBG,
Bangalore KARNATAKA 560054 India |
| Phone |
9480708128 |
| Fax |
|
| Email |
revathi8205@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical College and hospital
Department of Obstetrics and Gynaecology |
|
|
Primary Sponsor
|
| Name |
Ramaiah medical college |
| Address |
MSR Nagar Bangalore |
| 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 Revathi |
Ramaiah medical college and hospital |
Department of OBG, labour room, Msr nagar, Bangalore Bangalore KARNATAKA |
9480708128
revathi8205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O720||Third-stage hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Carbetocin for management of third stage of labour |
Injection Carbetocin 100 micrograms Single dose, intravenous route will be administered without any other confounding factor to subjects and then compared with the subjects who have been administered injection oxytocin 10 international units IV with or without additional uterotonic agents.
The study is done for a period of 18 months |
| Intervention |
Intravenous Administration of injection Carbetocin |
Injection Carbetocin 100 micrograms single dose intravenous route will be administered without any other confounding factor to subjects and then compared with the subjects who have been administered injection oxytocin 10IU with or without additional uterotonic agents. The study is done for a period of 18 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
(1) at or beyond 28 gestational weeks; (2) 18–45 years old; (2) at least one risk factor for developing atony.
|
|
| ExclusionCriteria |
| Details |
Participants with cardiovascular disorders, hepatic or renal disease, epilepsy, known allergies to oxytocin or carbetocin.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The aim of the study is to compare the effects of carbetocin with those of oxytocin in several dosing regimens for the prevention of uterine atony in patients undergoing full term vaginal delivery. The outcome is assessed in terms of blood loss, need for additional uterotonic agents, fall in blood pressure, side effects of the drug Carbetocin if any
|
Outcome is assessed immediately after delivery and 12 hours, 24 hours after delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study is aimed at comparing the effects of carbetocin vs oxytocin in prevention of postpartum hemorrhage following vaginal delivery in terms of:
Secondary outcomes -
Fall in hb
Requirement of additional uterotonic agents
Adverse effects
Need for blood transfusion |
Outcome is assessed immediately after delivery, 12 hours & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="116" Sample Size from India="116"
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)
|
10/09/2023 |
| 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="1" Months="5" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study includes all women who have delivered vaginally . Quantification of blood loss is done by making a list of dry weights for delivery items that may become blood soaked with directions on how to calculate blood loss. Quantification of blood loss is begun immediately after the infant’s birth (before delivery of the placenta) and the amount of fluid collected in a calibrated under-buttocks drape is assessed and recorded. Most of the fluid collected before delivery of the placenta is amniotic fluid, urine, and feces. If irrigation is used, the amount of irrigation from the total fluid that was collected is subtracted. The total volume of fluid collected in the under-buttocks drape is recorded. The preplacental fluid volume is subtracted from the post placental fluid volume to more accurately determine the actual blood loss. Most of the fluid collected after the delivery of the placenta is blood. The fluid volume collected in the drapes is added to the blood volume measured by weighing soaked items to determine the cumulative volume of blood loss or quantification of blood loss. All blood-soaked materials and clots are weighed to determine cumulative volume. 1 gram weight=1 milliliter blood loss volume. The equation* used when calculating blood loss of a blood-soaked item is WET Item Gram Weight - DRY Item Gram Weight=Milliliters of Blood Within the Item.. [10, 11, 12] Randomized controlled trials with outcome measure of blood loss ≥500ml are eligible if they compared carbetocin with oxytocin to prevent postpartum hemorrhage during prophylaxis of PPH in women following vaginal delivery. The primary outcome is blood loss of at least 500ml after vaginal delivery. The secondary outcomes will be blood loss of at least 1000ml; use of additional uterotonic agents; blood transfusion; uterine massage; flushing; vomiting; abdominal pain; nausea; dizziness; headache; palpitation; itching; shivering. Side-effects are also an important concern when choosing uterotonic agents. Although carbetocin seems to be an ideal agent compared to other uterotonic agents, some side-effects, such as vomiting, nausea, and dysarteriotony, are still concerning. Side-effects are also considered as secondary outcomes in these trials. Clinicians do not fully understand the side-effects of carbetocin to PPH, particularly the unanticipated ones. There seems to be a gap in the detailed presentation of the side-effects of carbetocin. Therefore, this study also aims to assess the side-effects of carbetocin compared to oxytocin in the prevention of PPH Carbetocin 100mcg IV will be administered without any other confounding factor to subjects and then compared with the subjects who have been administered oxytocin 10IU with additional uterotonic agents. |