| CTRI Number |
CTRI/2024/02/062831 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A0 study to assess safety and effectiveness of carbetocin vs oxytocin after delivery of baby in cesarean section to prevent excessive bleeding |
|
Scientific Title of Study
|
A double blinded randomized controlled study to assess safety and effectiveness of carbetocin vs oxytocin during active management of third stage, for prevention of PPH in patients undergoing 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 |
RAJANI SOMANATHAN |
| Designation |
Assistant Professor |
| Affiliation |
siddaganga medical college and research institute |
| Address |
Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute,
Tumkur, Karnataka
Tumkur KARNATAKA 572101 India |
| Phone |
8606605516 |
| Fax |
|
| Email |
kuttu2412@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
RAJANI SOMANATHAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
siddaganga medical college and research institute |
| Address |
Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute,
Tumkur, Karnataka
Tumkur KARNATAKA 572101 India |
| Phone |
8606605516 |
| Fax |
|
| Email |
kuttu2412@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
RAJANI SOMANATHAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
siddaganga medical college and research institute |
| Address |
Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute,
Tumkur, Karnataka
Tumkur KARNATAKA 572101 India |
| Phone |
8606605516 |
| Fax |
|
| Email |
kuttu2412@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology,
SIDDAGANGA medical college and research institute,
Tumkur, Karnataka |
|
|
Primary Sponsor
|
| Name |
siddaganga medical college and research institute |
| Address |
Siddaganga medical college and research institute
Tumkur, karnataka 572101 |
| 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 S RAJANI |
SIDDAGANGA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Room number 1,Out patient department, Department of Obstetrics and Gynaecology,Siddaganga medical college and research institute,
Tumkur, Karnataka 572101 Tumkur KARNATAKA |
8606605516
kuttu2412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Siddaganga Medical College and Research Institute, Tumakuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CARBETOCIN |
100mcg of IV Carbetocin slowly over one minute, during active management of third stage of labour. Blood loss, need for additional uterotonics ,side effects will be noted for the next 24 hours. |
| Comparator Agent |
OXYTOCIN |
10 Units of oxytocin slow IV during active management of third stage of labour.Blood loss, need for additional uterotonics, side effects will be noted for the next 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
willing to participate
gestational age 36 weeks-41 weeks
patients undergoing cesarean section |
|
| ExclusionCriteria |
| Details |
hypertensive
pre eclampsia
eclampsia
ante partum hemorrhage
bleeding disorders
thrombocytopenia
blood coagulation abnormalities
cardiovascular disorders
epilepsy
asthma
migraine
renal disease
liver disease
general anesthesia
retained placenta
placenta accreta
placenta previa
previous pph
grand multipara
fibroid with pregnancy
prolonged labour
hypersensitivity to oxytocin or carbetocin
traumatic pph |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO compare the safety and efficacy of carbetocin with oxytocin to prevent PPH during active management of third stage of labour. |
blood loss assesment intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the requirement for additional uterotonics in both groups |
need for additional uterotonics assesed intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour. |
| To compare adverse effects among both groups. |
adverse effects noted intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour. |
|
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
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)
|
27/02/2024 |
| 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="2" Months="0" Days="0" |
|
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 American College of Obstetricians and Gynecologists (ACOG) defines PPH as blood loss of more than or equal to 1000 ml, or blood loss that was accompanied by signs or symptoms of hypovolemia occurring within 24 h after birth, regardless of the mode of deliveryâ€1 PPH is the leading cause of maternal mortalityÙ°,currently accounting for approximately 25% of pregnancy-associated deaths worldwide.80% of PPH is due to uterine atonicity which is preventable.Active management of the third stage of labor(AMTSL) is done to prevent atonic PPH.This involves the use of interventions (including the use of uterotonics, early clamping of the umbilical cord and controlled cord traction). Uterotonics are oxytocin, methyl ergometrine, carbetocin, carboprost and misoprostol.2 Carbetocin is a heat stable analogue of oxytocin with a longer half life. WHO and FIGO recommends the use of oxytocin (10 IU, IM/IV) for the prevention of PPH for all births.The use of carbetocin (100 μg, IM/IV) is recommended for the prevention of PPH for all births in contexts where its cost is comparable to other effective uterotonics, and also in settings where oxytocin is unavailable (or its quality cannot be guaranteed).1,3 Our study aims to compare the effectiveness of oxytocin vs carbetocin in the active management of the third stage of labor among patients undergoing LSCS in a tertiary care centre by a randomized controlled double blinded study. 240 Antenatal women who are admitted for safe confinement and fulfilling the inclusion and exclusion criteria and giving informed written will be enrolled for the study. Routine obstetric examination and investigations will be done. Randomisation will be done by the sealed opaque envelope method.240 randomly generated treatment allocations within sealed opaque envelopes into either group A (OXYTOCIN 10 IU IV) or Group B(Carbetocin 100 mcg IV) will be placed in the OT in a box. In the Operation theater,the Anesthetist will take one of the envelopes and open it and the drug as per the group alloted will be loaded in the syringe.If general anesthesia is required, she will be excluded from the study.Under regional anesthesia, under aseptic precautions , LSCS will be done. Immediately after the delivery of the baby,AMTSL will be done.Either 100mcg of IV carbetocin slowly over a minute or 10 units of oxytocin slow IV as per the group allotted will be administered. Once the uterus is well contracted, Uterus will be closed in a single layer with non interlocking sutures using no 1 vicryl. If uterine atonicity is noted at any point during the intraoperative or postpartum period, additional oxytocics will be given as per need. The doses of these required will be recorded.Surgical methods of control of PPH will be resorted to if required.Any instances of traumatic PPH will be excluded from the study. Blood loss will be assessed by: A+B-C11 A. The difference in the dry and wet weight of the steripads,mops, packs used.1gm of difference will be considered as 1 ml of blood loss. B.The volume of the suction bottle.(ml) C.Amniotic fluid volume in ml.(AFI X 30) The vitals will be assessed immediately following delivery of the baby and then hourly for 2 hours. The subject will be assessed for adverse effects of metallic taste, fever, nausea, vomiting, headache, raise/fall in Blood Pressure, shivering, diarrhoea.Any other adverse reactions will be noted.Monitoring will be continued 6 th hourly for the first 24 hrs. Hb will be reassessed on post operative day 3 and recorded. The difference in the pre op and postoperative Hb will be noted. Patient will be discharged on post operative day 4 if stable. The details filled in the proforma will be statistically analyzed to reach a conclusion at the end of the study period. |