| CTRI Number |
CTRI/2021/02/031583 [Registered on: 26/02/2021] Trial Registered Prospectively |
| Last Modified On: |
13/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Two different Oxytocin dosage given to reduce bleeding for cesarean operation .
Note: oxytocin is commonly used drug, given to make the uterus contract after baby delivery |
|
Scientific Title of Study
|
“A comparative study between oxytocin bolus with infusion versus oxytocin infusion in minimizing uterine bleeding following Caesarean section: A randomized control trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harish Karanth |
| Designation |
Assosciate professor |
| Affiliation |
A.J Institute of Medical Sciences and Research Centre |
| Address |
A.J Institute of Medical Sciences and Research Centre
Department of Anaesthesia,
3rd floor
Kuntikana, Mangalore
Department of Anaesthesia,
Kuntikana, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09900910374 |
| Fax |
|
| Email |
harishkrnth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harish Karanth |
| Designation |
Assosciate professor |
| Affiliation |
A.J Institute of Medical Sciences and Research Centre |
| Address |
A.J Institute of Medical Sciences and Research Centre
Department of Anaesthesia,
Kuntikana, Mangalore
Department of Anaesthesia,
Kuntikana, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09900910374 |
| Fax |
|
| Email |
harishkrnth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harish Karanth |
| Designation |
Assosciate professor |
| Affiliation |
A.J Institute of Medical Sciences and Research Centre |
| Address |
A.J Institute of Medical Sciences and Research Centre
Department of Anaesthesia,
Kuntikana, Mangalore
Department of Anaesthesia,
Kuntikana, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09900910374 |
| Fax |
|
| Email |
harishkrnth@gmail.com |
|
|
Source of Monetary or Material Support
|
| A J Institute Of Medical Sciences And Research Centre, Mangalore. |
|
|
Primary Sponsor
|
| Name |
AJ Institute Of Medical Sciences And Research Centre |
| Address |
Kuntikana
Mangalore 575004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Harish Karanth |
A.J Institute of Medical Sciences & Research Centre |
1st floor operation theatre complex
Kuntikana
Mangalore
Dakshina Kannada
KARNATAKA |
9900910374
harishkrnth@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: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
iv oxytocin bolus with infusion |
i.v slow bolus of oxytocin 3 IU (3 IU diluted to 3ml with sterile water) over 1 minute and 15 IU oxytocin in 500 mL of 0.9% saline solution infused at 100ml/hr (bolus and infusion),for 24hours following delivery. |
| Intervention |
iv oxytocin infusion |
3ml of sterile water over 1minute and oxytocin infusion, 15 IU oxytocin in 500 ml saline 0.9% solution at a rate of 100 ml/h for 24hours following delivery |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
38.00 Day(s) |
| Gender |
Female |
| Details |
singleton/Twin pregnancies (>34 weeks) posted for elective caesarean section |
|
| ExclusionCriteria |
| Details |
Women with placenta previa, thrombocytopenia, coagulopathies, previous major obstetric haemorrhage (>1000 mL), fibroids, or women who are receiving anticoagulant treatment |
|
|
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 |
1. To compare the uterine tonicity between the group receiving oxytocin bolus with infusion and the group receiving oxytocin infusion only.
2. To determine the need for additional uterotonic agents between the group receiving oxytocin bolus with infusion and the group with oxytocin infusion only.
|
1. intra-operative; after the extraction of foetus, till the completion of surgery.
2. post-operative period, up to 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the amount of blood loss in women undergoing cesarean sections between the two groups.
2. To assess the need for additional blood transfusion perioperatively between the two groups.
|
Intraoperative and 24hrs Postoperative period |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/03/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Murphy DJ, MacGregor H, Munishankar B, McLeod G. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section—pilot study. ISRCTN 40302163. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2009 Jan 1;142(1):30-3.
2. Sartain JB, Barry JJ, Howat PW, McCormack DI, Bryant M. Intravenous oxytocin bolus of 2 units is superior to 5 units during elective Caesarean section. British journal of anaesthesia. 2008 Dec 1;101(6):822-6.
3. King KJ, Douglas MJ, Unger W, Wong A, King RA. Five unit bolus oxytocin at cesarean delivery in women at risk of atony: a randomized, double-blind, controlled trial. Anesthesia & Analgesia. 2010 Dec 1;111(6):1460-6.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oxytocin is routinely administered by intravenous bolus and infusion at caesarean section following delivery of the fetus. Oxytocin promotes uterine contraction and minimizes bleeding from placental site. Various oxytocin regimens have been suggested including only bolus dose, bolus with infusion of different doses,but till now no randomized trial being conducted for oxytocin infusion alone vs oxytocin bolus with infusion at low dose to see the effectiveness of uterine contraction and maternal side effects. |