| CTRI Number |
CTRI/2024/07/071389 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Carbetocin and Oxytocin for preventing bleeding in Postpartum women |
|
Scientific Title of Study
|
Comparison of efficacy of Carbetocin versus Oxytocin in the prevention of Postpartum hemorrhage An open label randomized controlled 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 |
Yukta Dhingra |
| Designation |
Postgraduate student |
| Affiliation |
AIIMS Bathinda |
| Address |
Labour room, ground floor D block, Department of Obstetrics and Gynaecology, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8010927847 |
| Fax |
|
| Email |
yukta.yd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lajya Devi Goyal |
| Designation |
Head of department |
| Affiliation |
AIIMS Bathinda |
| Address |
Room no. Department of Obstetrics and Gynaecology, AIIMS, Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9417658846 |
| Fax |
|
| Email |
lajja.goyal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yukta Dhingra |
| Designation |
Postgraduate student |
| Affiliation |
AIIMS BAthinda |
| Address |
Labour room, ground floor, D block, Department of Obstetrics and Gynaecology, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8010927847 |
| Fax |
|
| Email |
yukta.yd@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda, Mandi Dabwali Road, Bathinda, Punjab, India, Pin 151001 |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynaecology AIIMS Bathinda |
| Address |
Department of Obstetrics and Gynaecology, AIIMS Bathinda, Mandi Dabwali Road, Bathinda, Punjab, India - 151001 |
| 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 Yukta Dhingra |
AIIMS Bathinda |
Department of Obstetrics and Gynaecology, AIIMS Bathinda
Bathinda
PUNJAB |
8010927847
yukta.yd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bathinda, Bathinda, 151001 |
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 |
IV Carbetocin |
Inj Carbetocin 100mcg IV bolus after delivery of placenta |
| Comparator Agent |
IV Oxytocin |
10IU IV oxytocin in 500ml NS in 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women at 34 to 40 weeks of gestation undergoing vaginal delivery or cesarean section giving consent to participate |
|
| ExclusionCriteria |
| Details |
1.Known case of hypersensitivity to oxytocin and carbetocin13
2.Women with coagulation defects
3.Women with medical conditions (pulmonary, hepatic, renal or cardiovascular disease) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To compare incidence of Postpartum hemorrhage by the use of Carbetocin versus oxytocin |
1.Less than 24 hours of delivery
2.24 hours to 6 weeks postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the intrapartum blood loss in carbetocin versus oxytocin group
To compare proportion of women requiring additional uterotonic drugs after administration of carbetocin versus oxytocin
Comparison of adverse effects (nausea, vomiting & hypotension) among carbetocin versus oxytocin group |
Less than 24 hours of delivery |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
10/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
According to American College of Obstetrician and Gynecology, Postpartum hemorrhage is defined as a cumulative blood loss of more than 1000ml with signs and symptoms of hypovolemia within 24 hours of birth process, regardless of route of delivery. Primary PPH is defined as blood loss of more than 500ml after vaginal delivery and more than 1000ml after cesarean section which occurs in first 24 hours after delivery. It constitutes a major cause of maternal morbidity and mortality and complicates approximately 6% of all deliveries. It is the leading cause of maternal mortality and account for 1,25,000 deaths per year worldwide. PPH incidence in India is 2-2.5% of vaginal deliveries, 6% of cesarean section. About 1 woman dies in every 2 minutes, most of these deaths are preventable. Causes of PPH- 1. Tone (uterine atony)- 70% cases 2. Trauma (laceration,rupture) 3. Tissue (Retained tissue)- causes secondary PPH due to improper uterine retraction $. Thrombin deficiency (Coagulopathy) Treatment modalities available for management of PPH- First line- Medical management- Uterotonics- Inj Oxytocin, Inj Carbetocin, Inj methergine, Tab misoprostol Uterine tamponade (foley catheter, condom catheter, bakri balloon) Second line- Surgical management- B lynch sutures, uterine artery ligation, anterior division of internal iliac artery ligation Arterial embolization hysterectomy Oxytocin is frequently used as first choice in cesarean section. Due to its short half life (4-10 minutes), it requires continuous or repeated ad inistration whereas Carbetocin is a long acting analogue of oxytocin having half life of 40 minutes Oxytocin is susceptible to heat whereas, Carbetocin is heat stable There is a paucity of literature regarding comparison of oxytocin and carbetocin, thereforre we plan to conduct a study comp[aring incidence of PPH in postpartum period. The literature review does not clearly depict the superiority of one study method over other. Hence, we hypothesize that Carbetocin is equivalent to Oxytocin in prevention of PPH after delivery. The present hypothesis will be tested using an open label randomized controlled trial (RCT) study design. |