| CTRI Number |
CTRI/2025/08/092610 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 3 medicines oxytocin ,syntometrine and carbetocin control of post partum hemorrhage after delivery in women of reproductive age |
|
Scientific Title of Study
|
OXYTOCIN VERSUS SYNTOMETRINE VERSUS CARBETOCIN IN CONTROL OF POST PARTUM HEMORRHAGE : AN OPEN LABEL RANDOMISED CONTROL TRIAL |
| 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 Gagandeep Kaur |
| Designation |
First year Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, AIIMS BATHINDA
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, AIIMS BATHINDA
Bathinda
PUNJAB
151001
India |
| Phone |
9464446120 |
| Fax |
|
| Email |
gkbedi17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gagandeep Kaur |
| Designation |
First year Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, AIIMS BATHINDA
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, AIIMS BATHINDA
Bathinda
PUNJAB
151001
India |
| Phone |
9464446120 |
| Fax |
|
| Email |
gkbedi17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Garg |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, AIIMS BATHINDA
DEAPRTMENT OF OBSTETRICS AND GYNAECOLOGY, AIIMS BATHINDA
Bathinda
PUNJAB
151001
India |
| Phone |
6280628137 |
| Fax |
|
| Email |
priyanka.garg.u@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA, PUNJAB ,INDIA (PIN CODE- 151001) |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Gagandeep Kaur |
All India Institute of Medical Sciences, Bathinda |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Bathinda
Bathinda
PUNJAB |
9464446120
gkbedi17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O721||Other immediate postpartum hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARM 1- OXYTOCIN |
OXYTOCIN IN CONTROL OF POST PARTUM HEMORRHAGE AFTER DELIVERY IN WOMEN OF REPRODUCTIVE AGE |
| Intervention |
ARM2- SYNTOMETRINE |
SYNTOMETRINE IN CONTROL OF POST PARTUM HEMORRHAGE IN WOMEN OF REPRODUCTIVE AGE |
| Intervention |
ARM3- CARBETOCIN |
CARBETOCIN IN CONTROL OF POST PARTUM HEMORRHAGE IN WOMEN OF REPRODUCTIVE AGE |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with singleton pregnancy of more than 28 weeks of gestation undergoing vaginal delivery or cesarean section and giving consent to participate |
|
| ExclusionCriteria |
| Details |
1. Women with hypersensitivity or allergy to oxytocin , syntometrine or carbetocin.
2. Women with chronic hypertension, gestational hypertention, pre-eclampsia or ante-partum blood loss of more than 50ml.
3. Women with medical conditions like severe anemia and severe heart disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare incidence of Postpartum hemorrhage by the use of oxytocin versus
syntometrine versus carbetocin |
To compare incidence of Postpartum hemorrhage by the use of oxytocin versus
syntometrine versus carbetocin on day of operation and post op day 2 hemoglobin |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the intrapartum blood loss in oxytocin versus syntometrine versus
carbetocin group.
• To compare proportion of women who will require additional uterotonic drugs
after administration of oxytocin versus syntometrine versus carbetocin group
• Comparison of adverse effects (nausea, vomiting & hypotension) among
oxytocin versus syntometrine versus carbetocin group. |
• To compare the intrapartum blood loss in oxytocin versus syntometrine versus
carbetocin group.
• To compare proportion of women who will require additional uterotonic drugs
after administration of oxytocin versus syntometrine versus carbetocin group
• Comparison of adverse effects (nausea, vomiting & hypotension) among
oxytocin versus syntometrine versus carbetocin group. |
• To compare the intrapartum blood loss in oxytocin versus syntometrine versus
carbetocin group.
• To compare proportion of women who will require additional uterotonic drugs
after administration of oxytocin versus syntometrine versus carbetocin group
• Comparison of adverse effects (nausea, vomiting and hypotension) among
oxytocin versus syntometrine versus carbetocin group. |
• To compare the intrapartum blood loss in oxytocin versus syntometrine versus
carbetocin group.
• To compare proportion of women who will require additional uterotonic drugs
after administration of oxytocin versus syntometrine versus carbetocin group
• Comparison of adverse effects (nausea, vomiting and hypotension) among
oxytocin versus syntometrine versus carbetocin group. |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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)
|
18/08/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After a detailed history and physical examination of a pregnant female more than 28 weeks period of gestation and considering inclusion and exclusion critertia, patients will be recruited for the study. A participant information sheet will be given to the patients and after a verbal explanation about the study , written informed consent in patient’s vernacular language will be taken. A case record form will be used for collecting the data. The demographic history, menstrual history, contraceptive history, obstetric history, personal and family history of the participant will be taken A detailed examination of the patient will be done which will include general physical examination, respiratory, cardiovascular, abdominal examination and pelvic examination which will include per speculuim, per vaginum examination, if required. All routine investigations like complete blood count (CBC), Random blood sugar (RBS), urine routine and microscopy (URINE R/M), serum electrolytes (SE), liver function test (LFT), blood group (ABORH), prothrombin tine/international normalized ratio (PT/INR), viral markers, and obstetric ultrasonography if required will be done. 10 Randomisation will be done by using computer generated random number tables. All eligible participants who will give consent for the study will be randomly allocated to group A (receiving oxytocin) or group B (receiving syntometrine) or Group C (receiving carbetocin). Women in group A will receive 10 IU IM injection of oxytocin , women in group B will receive 5 IU of oxytocin +0.5mg of ergometrine (i.e. 1ml of syntometrine) and women in group C will receive 100 micrograms of carbetocin after delivery of baby .The hemoglobin levels of the participant will be compared from the day of admission in labour room to 24 hours after delivery. The following will be taken into account amongst three groups. 1) The use of additional uterotonic agents 2) Weighed blood loss (by comparing dry weight and weight of pad soaked with blood) 3) Duration of third stage of labour 4) Transfusion of blood products 5) Use of other non-medical measures to treat PPH (like intrauterine balloon tamponade, uterine compression suture) . |