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Trial registered on ANZCTR


Registration number
ACTRN12612000466842
Ethics application status
Not yet submitted
Date submitted
24/04/2012
Date registered
27/04/2012
Date last updated
24/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Carbetocin vs Oxytocin at Emergency Caesarean Section
Scientific title
Carbetocin vs Oxytocin (Syntocinon) to Improve Uterine Tone at Emergency Caesarean Section
Secondary ID [1] 280384 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post partum haemorrhage at emergency caesarean section 286363 0
Condition category
Condition code
Reproductive Health and Childbirth 286607 286607 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
100 microgram intravenous(IV) injection of carbetocin will be given immediately after delivery of the baby at emergency caesarean section.
Intervention code [1] 284749 0
Treatment: Drugs
Intervention code [2] 284765 0
Prevention
Comparator / control treatment
two groups will be included in the trial. both will receive treatment immediately after the baby is born at emergency caesarean section. control: 5 unit syntocinon bolus IV Intervention: 100 micrograms carbetocin IV
Control group
Active

Outcomes
Primary outcome [1] 287021 0
Need for further uterotonics: which ones.
the operator will subjectively judge if the uterus is atonic. when atony is identified the normal protocol for post partum haemorrhage will be initiated.
Timepoint [1] 287021 0
after delivery of the fetus and administration of the chosen oxytocic, before closure of the rectal sheath at caesarean section
Secondary outcome [1] 297220 0
Post-operative haemoglobin compared to pre-op
Timepoint [1] 297220 0
day 1 post caesarean section
Secondary outcome [2] 297221 0
Need for uterine massage for >5minutes
This will be subjectively asessd by the operator
Timepoint [2] 297221 0
after delivery of the fetus and administration of the chosen oxytocic, bofore closure of the rectal sheath at caesarean section
Secondary outcome [3] 297222 0
Total subjective estimated blood loss in theatre. Suction is used to suck the excess blood into a measuring container. this amount will be recorded and any swabs soaked with blood will be weighed. this amount will be added to the suction amount to give the estimated blood loss
Timepoint [3] 297222 0
after closure of the skin at caesarean section
Secondary outcome [4] 297223 0
Post-op blood loss (ie not from EBL in theatre).
any swabs/pads will be weighed to estimate the amount of blood lost.
Timepoint [4] 297223 0
from leaving theatre post caesarean section until 24 hours post caesarean section ( ie primary post partum haemorrhage)
Secondary outcome [5] 297224 0
Fundal height above/below the umbilicus day 1
Timepoint [5] 297224 0
day 1 post caesarean section

Eligibility
Key inclusion criteria
anyone having an emergency caesarean section at Frankston Hospital who have given consent to be part of the trial. Age>16. >37 weeks gestation. <3 previous caesarean sections. epidural or spinal anaesthesia
Minimum age
17 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
previous adverse reaction to carbetocin/syntocinon. History of vascular, hepatic or renal problems. Lack of consent. <37 weeks gestation. Placenta praevia. Placental abruption. >2 caesarean sections. Patients having an elective caesarean section. general anaesthetic

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
a list of numbers which are randomly assigned either syntocinon or carbetocin will be generated by a computer programme. patients will receive each number in consecutive order. the patient will receive the corresponding vial which has been blinded at pharmacy level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the sequence will be produced from a computer programme that generates random lists. this will be done at pharmacy level and none of the oprating or anaesthetic doctors will have access to this.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285153 0
Hospital
Name [1] 285153 0
Frankston Hospital
Address [1] 285153 0
Hastings Road
Frankston
3199
Victoria
Country [1] 285153 0
Australia
Primary sponsor type
Individual
Name
Carole-anne Whigham
Address
Womens Health Unit
Frankston Hospital
Hastings Road
Frankston
3199
Vic
Country
Australia
Secondary sponsor category [1] 284015 0
Individual
Name [1] 284015 0
Professor A Trivedi
Address [1] 284015 0
Womens Health Unit
Frankston Hospital
Hastings Road
Frankston
3199
Vic
Country [1] 284015 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287169 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 287169 0
Mount Eliza Centre
Jacksons Road
Mt Eliza VIC 3930
Ethics committee country [1] 287169 0
Australia
Date submitted for ethics approval [1] 287169 0
17/04/2012
Approval date [1] 287169 0
Ethics approval number [1] 287169 0
HREC/12/PH/28

Summary
Brief summary
Reducing maternal mortality rates has been a worldwide goal for many years. Post partum haemorrhage is the main cause of obstetric haemorrhage accounting for 14 million cases worldwide. It is the leading cause of maternal death throughout the world. In Victoria, Australia, in 2002 the post partum haemorrhage rate was 9.2%. Post partum haemorrhage is associated with ICU admission, the need for blood transfusion and a longer hospital stay, which is at considerable cost. The majority of post partum haemorrhage is caused by uterine atony, so finding an effective agent to prevent uterine atony is paramount in reducing maternal morbidity and mortality. Operative delivery is a known risk factor for PPH therefore improving uterine tone at caesarean section is an important parameter if rates are to be reduced. Carbetocin is a synthetic long-acting analogue of oxytocin used to improve uterine tone. Studies have shown that a single intra-muscular injection of carbetocin is more effective than syntocinon infusion for preventing uterine atony at elective caesarean section, and this is the current practice at Frankston Hospital. Carbetocin is currently licensed in Australia to reduce uterine atony at elective caesarean section, however the efficacy at emergency caesarean section is unclear. In this prospective randomised trial we aim to discover if carbetocin 100 micrograms iv or Syntocinon 5 unit iv bolus, is more effective at improving post partum haemorrhage rates in emergency caesarean sections, by measures of need for further uterotonics, need for >5 minutes uterine massage and haemoglobin drop.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 34105 0
Address 34105 0
Country 34105 0
Phone 34105 0
Fax 34105 0
Email 34105 0
Contact person for public queries
Name 17352 0
Professor Amar Trivedi
Address 17352 0
Womens Health Unit
Frankston Hospital
Hastings Road
Frankston
3199
Vic
Country 17352 0
Australia
Phone 17352 0
+61427215515
Fax 17352 0
Email 17352 0
ATrivedi@phcn.vic.gov.au
Contact person for scientific queries
Name 8280 0
Carole-Anne Whigham
Address 8280 0
Womens Health Unit
Frankston Hospital
Hastings Road
Frankston
3199
Vic
Country 8280 0
Australia
Phone 8280 0
+61404644029
Fax 8280 0
Email 8280 0
c.a.whigham@doctors.net.uk

No information has been provided regarding IPD availability
Summary results
No Results