Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001811291p
Ethics application status
Submitted, not yet approved
Date submitted
2/11/2018
Date registered
7/11/2018
Date last updated
7/11/2018
Date data sharing statement initially provided
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
SECTION Study: Syntometrine versus placebo during Emergency Caesarean secTION
Scientific title
SECTION Study: Syntometrine versus placebo during Emergency Caesarean secTION for the prevention of postpartum haemorrhage.
Secondary ID [1] 296495 0
N/S
Universal Trial Number (UTN)
Trial acronym
SECTION Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum haemorrhage
 310279 0
Condition category
Condition code
Reproductive Health and Childbirth 309013 309013 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm: Single dose of intramuscular Syntometrine (500 mcg Ergometrine, 5 IU Oxytocin, 1mL, Thigh) in addition to standard care of 5 IU oxytocin IV plus IV infusion of 10 IU oxytocin per hour for 4 hours.
Administered immediately after Emergency caesarean section.
Intervention code [1] 312816 0
Treatment: Drugs
Comparator / control treatment
Control arm: Single dose of intramuscular 0.9% sodium chloride (placebo, 1mL, Thigh) in addition to standard care of 5IU oxytocin IV plus IV infusion of 10 IU oxytocin per hour for 4 hours.
Administered after Emergency caesarean section.
Control group
Placebo

Outcomes
Primary outcome [1] 307971 0
Postpartum haemorrhage.
500mls
PPH will be assessed clinically by the obstetrician as per standard practice (through clinical estimation or objective quantification via suction volume and weighing of packs). Recording of this outcome will occur prospectively through the study-specific case report form.
Timepoint [1] 307971 0
Within 24 hours of delivery.
Secondary outcome [1] 353530 0
Massive postpartum haemorrhage.
1000mls
PPH will be assessed clinically by the obstetrician as per standard practice (through clinical estimation or objective quantification via suction volume and weighing of packs). Recording of this outcome will occur prospectively through the study-specific case report form.
Timepoint [1] 353530 0
within 24 hours of delivery
Secondary outcome [2] 353531 0
A change in Haemoglobin levels, assessed via pathology services measured in grams/Litre from baseline to day 2. This will be assessed as a continuous variable and collected prospectively using a study-specific case report form after the treating team have looked up the pathology result.
Timepoint [2] 353531 0
Day 2 post delivery
Secondary outcome [3] 353532 0
In-hospital secondary postpartum haemorrhage
Defined as greater than or equal to 500 mLs estiamted or measured blood loss that starts greater than 24 hours after delivery, whilst still in hospital.
PPH will be assessed clinically by the obstetrician as per standard practice (through clinical estimation or objective quantification via suction volume and weighing of packs). Recording of this outcome will occur prospectively through the study-specific case report form.
Timepoint [3] 353532 0
Until discharge from hospital
Secondary outcome [4] 353533 0
Blood transfusions, assessed by timing of and number of units of packed red blood cells received. Recording of this outcome will occur prospectively through the study-specific case report form.
Timepoint [4] 353533 0
Until discharge from hospital
Secondary outcome [5] 353534 0
Adjunct postpartum haemorrhage management defined as any of" Fundal massage, Bimanual compression, return to theatre, uterine packing, B-lynch suture, Bilateral ligation of uterine arteries, bilateral ligation of internal iliac arteries, selective arterial embolisation, hysterectomy.
Recording of this outcome will occur prospectively through the study-specific case report form. The time point for this outcome is until discharge from hospital
Timepoint [5] 353534 0
until discharge from hospital
Secondary outcome [6] 353535 0
Length of stay, assessed in hours from admission to time of discharge. Recording of this outcome will occur prospectively through the study-specific case report form.
Timepoint [6] 353535 0
Until discharge
Secondary outcome [7] 353536 0
ICU admission, assessed as a binary variable, defined by whether or not the patient during their in-hospital stay required admission to intensive care unit. Recording of this outcome will occur prospectively through the study-specific case report form.
Timepoint [7] 353536 0
Until discharge
Secondary outcome [8] 353537 0
Adverse effects of study medication, defined as any of the following:
o Anaphylactic/anaphylactoid reaction
o Cerebrovascular accident
o Headache
o Dizziness
o Myocardial infarction
o Coronary arteriospasm
o Bradycardia
o Cardiac arrhythmias
o Chest pain
o Hypertension
o Vomiting
o Nausea
o Abdominal pain
o Rash
o Angioedema
These will be recorded prospectively using the study-specific Case Report Form. These will be specifically checked and asked for prospectively using both clinical judgement of the clinical team, and patient report.
Timepoint [8] 353537 0
Until discharge from hospital

Eligibility
Key inclusion criteria
- Adult patients (greater than or equal to 18 years of age)
- Women
- Singleton Pregnancy
- Undergoing an Emergency Caesarean section
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Planning an elective caesarean section delivery
- Current use of anticoagulant agents
- Past history of a bleeding diathesis
- Contraindications to study drug
o Known allergy to Syntometrine, oxytocin, ergometrine, acetic acid, chlorobutanol hemihydrate, maleic acid, or sodium acetate trihydrate
o Severe hypertension, pre-eclampsia, or eclampsia
o Severe cardiac disorders
o Hepatic or renal impairment
o Occlusive vascular disease
o Sepsis
o Concurrent use of clarithromycin, erythromycin, HIV protease or reverse transcriptase inhibitors, or azole antifungals

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)
Allocation will be concealed. Participants will be enrolled during antenatal clinics/consultations. The randomisation will take place when/if they present for an emergency caesarean section. Thus the chronology conceals the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation was performed assuming a 21% rate of PPH following emergency caesarean section, and a clinically significant benefit reducing that rate to 10%.
This produced a sample size of 220 per arm, with some inflation for potential missing data.

Data analysis:
The primary outcome (Presence of PPH) will be assessed between the intervention and control groups using a chi-squared statistic. Other statistical analyses will be as follows:
Continuous variables will be summarised as mean and standard deviation (SD) for normally distributed variables, and median and interquartile range (IQR) in cases of non-parametric distribution. Categorical variables will be presented as frequencies (n) and proportions (%).
Continuous variables will be assessed using the Student’s t-test, whilst skewed or categorical data will use the chi-squared test or Fisher’s exact test (if any cell is <5). Non-parametric ordinal and continuous data will be assessed with Mann Whitney U Test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2019
Actual
Date of last participant enrolment
Anticipated
31/05/2021
Actual
Date of last data collection
Anticipated
31/07/2021
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301084 0
Hospital
Name [1] 301084 0
Department of Obstetrics & Gynaecology,Ballarat Base Hospital
Country [1] 301084 0
Australia
Primary sponsor type
Individual
Name
Dr Russell Dalton
Address
Obstetrics & Gynaecology Ballarat
1105 Howitt Street, Wendouree VIC 3355
Country
Australia
Secondary sponsor category [1] 300693 0
None
Name [1] 300693 0
N/A
Address [1] 300693 0
N/A
Country [1] 300693 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301834 0
Ballarat Health Services & St John of God Human Research Ethics Committee
Ethics committee address [1] 301834 0
Ethics committee country [1] 301834 0
Australia
Date submitted for ethics approval [1] 301834 0
05/11/2018
Approval date [1] 301834 0
Ethics approval number [1] 301834 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88266 0
Dr Russell Dalton
Address 88266 0
Obstetrics & Gynaecology Ballarat
1105 Howitt Street, Wendouree VIC 3355
Country 88266 0
Australia
Phone 88266 0
+61 03 5339 8100
Fax 88266 0
Email 88266 0
[email protected]
Contact person for public queries
Name 88267 0
Jeremy Abetz
Address 88267 0
Ballarat Health Services
1 Drummond St North, Ballarat Central, VIC 3500
Country 88267 0
Australia
Phone 88267 0
+61 03 5320 4000
Fax 88267 0
Email 88267 0
[email protected]
Contact person for scientific queries
Name 88268 0
Jeremy Abetz
Address 88268 0
Ballarat Health Services
1 Drummond St North, Ballarat Central, VIC 3500
Country 88268 0
Australia
Phone 88268 0
+61 03 5320 4000
Fax 88268 0
Email 88268 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are not seeking ethics approval for this use of the data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.