Home » Trials » SLCTR/2013/019
Effectiveness of 5-IU oxytocin bolus and 20 IU infusion compared to 5-IU oxytocin bolus and placebo infusion in the control of blood loss during and after ante-partum lower segment caesarean section.
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SLCTR Registration Number
SLCTR/2013/019
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Effectiveness of 5-IU oxytocin bolus and 20 IU infusion compared to 5-IU oxytocin bolus and placebo infusion in the control of blood loss during and after ante-partum lower segment caesarean section.
Public Title of Trial
Study on the use of oxytocin bolus and infusion to prevent blood loss during caesarean section
Disease or Health Condition(s) Studied
Blood loss during and after caesarean section
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
IIs 5 IU oxytocin bolus followed by 20 IU oxytocin infusion more effective than 5 IU oxytocin bolus alone in the control of blood loss during and after ante partum lower segment caesarean section?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Prevention
Study Phase
Not Available
Intervention(s) planned
Consenting participants will be randomized into 2 arms. Women in the intervention arm will receive a 5IU IV bolus of oxytocin will be given over 5–10 s to each women when the umbilical cord was clamped. Then in group A patients, 500 mL of isotonic saline solution at a rate of 125 mL/ h which will be continued for four hours and in group B patients, 20 IU oxytocin in 500 mL isotonic saline solution at a rate of 125 mL/h which will continued for four hours were given.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Mean blood loss in mililiters 2. Post partum haemorrhage (no PPH -500-1000ml -1000-3000ml ->3000ml) 3. Maternal Hb and PCV 4. Need for blood transfusion 5. Need for therapeutic uterotonics |
[
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Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
92
Countries of recruitment
Sri Lanka
Anticipated start date
2013-05-29
Anticipated end date
2013-08-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-03-20
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.J.Kajendran
Registrar (Obstetrics & Gynaecology)
Teaching Hospital, Peradeniya
0772616255
kajendranj@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
