| CTRI Number |
CTRI/2013/12/004193 [Registered on: 06/12/2013] Trial Registered Prospectively |
| Last Modified On: |
05/12/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
USE OF OXYTOCIN DURING EMERGENCY CESAREAN SECTION: A STUDY COMPARING OXYTOCIN INFUSION WITH & WITHOUT OXYTOCIN BOLUS |
|
Scientific Title of Study
|
A randomized control trial comparing use of oxytocin bolus with and without oxytocin infusion in women with cesarean section after extraction of fetus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chanderdeep Sharma |
| Designation |
Senior Resident |
| Affiliation |
Dr RPGMC Kangra at Tanda (HP) |
| Address |
Set No. 112, Vivekanand Hostel, Dr RPGMC Kangra at Tanda (HP)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Verma |
| Designation |
Proffessor & Head |
| Affiliation |
Dr RPGMC Kangra at Tanda (HP) |
| Address |
Dr RPGMC Kangra at Tanda (HP)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418080404 |
| Fax |
|
| Email |
sureshsverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chanderdeep Sharma |
| Designation |
Senior Resident |
| Affiliation |
Dr RPGMC Kangra at Tanda (HP) |
| Address |
Set No. 112, Vivekanand Hostel, Dr RPGMC Kangra at Tanda (HP)
HIMACHAL PRADESH
176001
India |
| Phone |
9218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra at Tanda HP |
| Address |
Dr RPGMC Kangra at Tanda (HP) |
| 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 Chanderdeep Sharma |
Dr RPGMC Kangra at Tanda (HP) |
Labor room operation theatre, department of Obstetrics & Gynecology, Dr Rajendra Prasad Government Medical College, Kangra at Tanda (HP)
Kangra
HIMACHAL PRADESH |
9218925471
cdsharma2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr RPGMC Kangra at Tanda (HP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
women for emergency cesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal saline bolus of 3 ml after delivery of fetus in emergency cesarean section and umbilical cord is clamped |
Women in this group will receive 3 ml of placebo solution (normal saline alone) bolus over 15 seconds after delivery of the fetus, which will be followed immediately by continous infusion of oxytocin 10 IU in 500 of 0.9% normal saline at the rate of 40 mU/min for a period of at least two hours after caesarean section. |
| Intervention |
oxytocin bolus 3 IU after delivery of fetus in emergency cesarean section and umbilical cord is clamped |
Women in this group will receive 3 IU of oxytocin (diluted as 3 ml of solution in normal saline) bolus over 15 seconds after delivery of the fetus, which will be followed immediately by continous infusion of oxytocin 10 IU in 500 of 0.9% normal saline at the rate of 40 mU/min for a period of at least two hours after caesarean section. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
• Singleton pregnancy/Woman for emergency caesarean section as per obstetrical indication/Period of gestation between 36 to 41 weeks |
|
| ExclusionCriteria |
| Details |
• Twin pregnancy /severe pre-eclampsia/ HELLP syndrome/Co-agulopathy/Abruptio placentae/Intra-uterine fetal death/Malformed fetus/Uncontrolled diabetes mellitus/Chorio-amniotis/Known case of thrombophilia/ Known case of chronic Renal or liver disease /previous classical caesarean section/ hysterotomy/previous uterine surgery (caesarean section, myomectomy, hysterotomy, polypectomy, lysis of uterine synechia, or hysteroscopic metroplasty) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME
The primary outcome is major obstetrical hemorrhage following caesarean section. (defined as blood loss 1000ml ).
|
24 hours after LSCS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Hemodynamic profile ( BP, mean arterial pressure, pulse rate)
• Severe anemia ( 20% fall in Hb post operative)
• Need of blood transfusion
• Side effect profile
• Duration of surgery
• Need for manual removal of placenta
|
24 hours after LSCS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2013 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
80 women for emergency cesarean section will be randomized in to two groups after fulfillment of inclusion and exclusion criteria. Group 1 will receive 3 IU oxytocin bolus and group 2 will receive 3 ml of placebo (0.9% normal saline solution), after delivery of fetus and clamping of umbilical cord. All women will receive oxytocin infusion @ 40 mU/min. All women will receive 2 ml (0.5%) bupivacaine intra-thecally in L3-L4. These women will be compared for obstetrical hemorrhage, hemodynamic profile (BP, Pulse rate, Mean arterial pressure), > 20% fall in hematocrit, need for blood transfusion, side effect profile, duration of surgery and need for manual removal of placenta. |