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Trial registered on ANZCTR


Registration number
ACTRN12607000631404
Ethics application status
Approved
Date submitted
7/12/2007
Date registered
12/12/2007
Date last updated
30/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion at elective caesarean section.
Scientific title
A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion for the prevention of uterine atony and post partum haemorrhage at elective caesarean section.
Secondary ID [1] 288031 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum haemorrhage 2612 0
Elective caesarean section 2613 0
Uterine atony 2614 0
Condition category
Condition code
Reproductive Health and Childbirth 2730 2730 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the management of the third stage of labour at elective caesarean section, a single dose intravenous bolus injection of 5 IU (international units) oxytocin plus 20 IU (international units) oxytocin intravenous infusion (rate 250mls hour infused over 4 hours).
Intervention code [1] 2351 0
Treatment: Drugs
Comparator / control treatment
For the management of the third stage of labour at elective caesarean section, a single dose intravenous bolus injection of 5 IU (international units) oxytocin alone.
Control group
Active

Outcomes
Primary outcome [1] 3623 0
Requirement for additional uterotonic measures
Timepoint [1] 3623 0
24 hours postpartum
Secondary outcome [1] 6064 0
Volume of fluid (crystalloid/colloid) replacement required to correct hypovolaemia.
Timepoint [1] 6064 0
Prior to discharge
Secondary outcome [2] 6065 0
Number of women administered blood products (packed red cells, platelets, fresh frozen plasma).
Timepoint [2] 6065 0
Prior to discharge
Secondary outcome [3] 6066 0
A return to theatre within 24 hours in order to arrest bleeding/haemorrhage.
Timepoint [3] 6066 0
24 hours
Secondary outcome [4] 6067 0
A change in postnatal day 1 haemoglobin ("Hb") (compared to preoperative measurement).
Timepoint [4] 6067 0
24 hours
Secondary outcome [5] 6068 0
Composite serious maternal morbidity/mortality (Admission to High Dependency Unit/Intensive Care Unit "HDU/ITU", Prolonged postnatal stay (> 5 days), hysterectomy, haematologic dysfunction (e.g disseminated intravascular coagulation, laparotomy, blood loss >1,000mls, death
Timepoint [5] 6068 0
Prior to discharge

Eligibility
Key inclusion criteria
Pregnancy: Singleton only Fetus: Alive only Gestation: 37 weeks - 41 weeks Surgery: Elective lower segment caesarean section Anaesthesia: Regional anaesthesia (spinal, epidural, combined spinal epidural (CSE)) Past medical history: No significant maternal medical or obstetric disorders Parity: <3 (equal to or less than 3): Pre-op Haemoglobin: "Hb" > (equal to or more than) 100g/dl Language: Fluency in English Age: >18 years of age (equal to or more than)
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Active labour (presence of regular uterine activity accompanied by cervical dilation)

Emergency caesarean section

General anaesthesia

(Less than) <37 completed weeks of pregnancy

Fetal demise

Multiple pregnancy

Polyhydramnios

Macrosomic fetus (Estimated fetal weight "EFW" >4.5 kg)

Past history of post partum haemorrhage 'PPH' requiring additional measures

Antepartum haemorrhage (requiring hospitalisation)

Known abnormality of placentation (e.g. placenta praevia, vasa, praevia, accreta)
Presence of uterine leiomyoma

Classical uterine incision (Past history of or intention at this lower segment caesarean section "LUSCS").

Evidence of intrauterine infection e.g. chorioamnionitis

Significant maternal medical disorders: Cardiac disease/arrhythmias. Hypertensive disorders: chronic/essential hypertension /pregnancy induced hypertension "PIH"/Pre eclampsia +/- magnesium sulphate "MgSO4" therapy. Known inherited coagulopathies, haemorrhagic/bleeding disorders (family history/known carriers of same) or other abnormalities of coagulation. Currently prescribed anticoagulant medication. Obstetric cholestasis. Connective tissue disorders

Past history of ruptured uterus

Previous adverse reaction to oxytocin (Syntocinon®)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation - stratified for parity and hospital
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/03/2008
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
2/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
948
Accrual to date
Final
474
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 515 0
3168
Recruitment postcode(s) [2] 516 0
3175

Funding & Sponsors
Funding source category [1] 2871 0
University
Name [1] 2871 0
Monash University
Country [1] 2871 0
Australia
Primary sponsor type
Hospital
Name
Monash University
Address
Department of Obstetrics
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 2588 0
None
Name [1] 2588 0
Address [1] 2588 0
Country [1] 2588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4812 0
Southern Health Human Research and Ethics Committee
Ethics committee address [1] 4812 0
Research Directorate
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 4812 0
Australia
Date submitted for ethics approval [1] 4812 0
05/12/2007
Approval date [1] 4812 0
16/01/2008
Ethics approval number [1] 4812 0
*07212C

Summary
Brief summary
This double-blind randomised controlled trial, will assess the relative effectiveness of two different oxytocin regimens for the prevention/treatment of haemorrhage after a caesarean section
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28235 0
Prof Euan M.Wallace
Address 28235 0
Department of Obstetrics and Gynaecology
Monash University
L5 Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168, Australia
Country 28235 0
Australia
Phone 28235 0
+61 3 95945145
Fax 28235 0
Email 28235 0
[email protected]
Contact person for public queries
Name 11392 0
Ms. Joanne C. Mockler
Address 11392 0
Department of Obstetrics
Monash University
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 11392 0
Australia
Phone 11392 0
+61 3 85722840
Fax 11392 0
+61 3 95946389
Email 11392 0
[email protected]
Contact person for scientific queries
Name 2320 0
Professor Euan M. Wallace
Address 2320 0
Department of Obstetrics
Monash University
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 2320 0
Australia
Phone 2320 0
+61 3 95945145
Fax 2320 0
+61 3 95946389
Email 2320 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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