| CTRI Number |
CTRI/2025/05/087071 [Registered on: 19/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison study Between Oxytocin and Carbetocin for Preventing Heavy Bleeding After Cesarean Delivery |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF OXYTOCIN VERSUS CARBETOCIN IN THE PREVENTION OF POST PARTUM HEMMORHAGE IN 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 |
Lavanya S |
| Designation |
Postgraduate |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Obstetrics and Gynaecology, ACS Medical College, Velappanchavadi , Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9940104255 |
| Fax |
|
| Email |
lavdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi Gnanasekaran |
| Designation |
Professor and Unit chief |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
ACS MEDICAL COLLEGE AND HOSPITAL, Velappanchavadi, Chennai, Tamilnadu, India
Thiruvallur
TAMIL NADU
600030
India |
| Phone |
9003166440 |
| Fax |
|
| Email |
sekaran.viji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lavanya S |
| Designation |
Postgraduate |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Obstetrics and Gynaecology, ACS medical college and hospital, Velappanchavadi, Chennai,Tamilnadu, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9940104255 |
| Fax |
|
| Email |
lavdoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACS MEDICAL COLLEGE, Vellapanchavadi, Chennai, Tamilnadu, India. Pincode - 600077 |
|
|
Primary Sponsor
|
| Name |
Lavanya S |
| Address |
IHFD Abodes, 3rd main road, Shenoy nagar, Chennai, Tamilnadu, India -600030 |
| Type of Sponsor |
Other [Self] |
|
|
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 Lavanya S |
ACS MEDICAL COLLEGE AND HOSPITAL |
Department of Obstetrics and Gynaecology,ACS MEDICAL COLLEGE AND HOSPITAL, POONAMALLE HIGH ROAD, VELAPPANCHAVADI, CHENNAI - 77
Thiruvallur
TAMIL NADU |
9940104255
lavdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGR INSTITUTE (ACS MEDICAL COLLEGE AND HOSPITAL) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carbetocin |
A total of 252 women with term singleton pregnancies undergoing Caesarean will be randomized into 2 groups. Group A includes 126 women who will receive 100μg (room temperature stable) Carbetocin diluted in 10 ml normal saline injected intravenously over 1-2 minutes immediately after birth of the baby during the active management of third stage of labour as per WHO criteria. Group B included 126 women who will receive 10 IU Oxytocin (stored at 2-8ºC) in 500 ml normal saline intravenously at 20-100 drops/minute immediately after birth of the baby during the active management of third stage of labour as per WHO criteria. To study the efficacy of Carbetocin as compared to Oxytocin in the prevention of postpartum hemorrhage. |
| Comparator Agent |
Oxytocin |
A total of 252 women with term singleton pregnancies undergoing Caesarean will be randomized into 2 groups.
Group A includes 126 women who will receive 100μg (room temperature stable) Carbetocin diluted in 10 ml normal saline injected intravenously over 1-2 minutes immediately after birth of the baby during the active management of third stage of labour as per WHO criteria.
Group B included 126 women who will receive 10 IU Oxytocin (stored at 2-8ºC) in 500 ml normal saline intravenously at 20-100 drops/minute immediately after birth of the baby during the active management of third stage of labour as per WHO criteria.
To study the efficacy of Carbetocin as compared to Oxytocin in the prevention of postpartum hemorrhage.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
Term gestation (37-40 weeks of gestation)
Elective / Emergency Cesarean section
Patients willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Spontaneous / Assisted vaginal delivery
High risk factors predisposing for Atonic Post partum hemorrhage like:
Multiple pregnancy
Polyhydramnios
Antepartum Hemorrhage
Large for gestational age (more than 4 kg)
Known allergy to Carbetocin / Oxytocin
Patients not willing to sign informed consent.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of Carbetocin as compared to Oxytocin in the prevention of postpartum hemorrhage.
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time required for placental separation in both groups.
To assess the amount of blood loss in both groups during the third stage of labour.
To assess the need for the use of additional uterotonic agents in both groups in the event of post-partum hemorrhage.
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2025 |
| 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 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
|
ØWritten informed consent shall be
obtained from all patients.
ØPatients’ demographic data, including
age, parity, gestation age will be noted. Complete history, physical and obstetric
examination of all participants shall be done. Routine blood investigations and obstetric
ultrasound shall be performed.
ØA
total of 252 women with term singleton pregnancies undergoing Caesarean will be
randomized into 2 groups.
ØGroup
A includes 126 women who will receive 100μg
(room temperature stable) Carbetocin diluted in 10 ml normal saline injected intravenously over 1-2 minutes immediately after birth of the baby during the active management of
third stage of labour as per WHO criteria.
ØGroup
B included 126 women who will receive 10
IU Oxytocin (stored at 2-8ºC) in 500 ml normal saline intravenously at 20-100
drops/minute immediately after birth of the
baby during the active management of third stage of labour as per WHO criteria.
OUTCOME MEASURES: qTo
assess the number of cases developing atonic PPH inspite of administering Oxytocin / Carbetocin.
qTo compare the time required for
placental separation in both groups.
qTo assess the need for use of additional
uterotonic drugs in both groups in the event of post-partum haemorrhage.
1. Carboprost (PGF2alpha)
2. Misoprostol
3. Methylergometrine
qTo assess the amount blood loss during
the third stage of labour in both groups.
â–ªIt
is assessed by measuring the Pre and Post operative Haemoglobin and
Haematocrits. The following formulas are employed in calculating the blood loss
 Calculated
pregnancy blood volume = 0.75 [maternal height (inches) (x) 50] + [maternal
weight in
pounds (x) 25] Percent
of blood volume lost = Predelivery Hematocrit –Postdelivery Hematocrit /
Predelivery Hematocrit  Calculated
estimated blood loss (cEBL)=Calculated
pregnancy blood volume-Percent of blood volume lost. |