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    Clinical Trial Results:
    Intramuscular oxytocics: A multi-centre randomised comparison study of intramuscular Carbetocin, Syntocinon and Syntometrine for the third stage of labour following vaginal birth

    Summary
    EudraCT number
    		 2014-001948-37
    Trial protocol
    		 GB  
    Global end of trial date
    24 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2020
    First version publication date
    15 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3344
    Additional study identifiers
    ISRCTN number
    		 ISRCTN10232550
    US NCT number
    		 NCT02216383
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    North Bristol NHS Trust
    Sponsor organisation address
    Southmead Hospital, Bristol, United Kingdom, BS10 5NB
    Public contact
    Helen Lewis-White, North Bristol NHS Trust, 0117 41 49333, Helen.Lewis-White@nbt.nhs.uk
    Scientific contact
    Prof Tim Draycott, North Bristol NHS Trust, 0117 41 46764, tim.draycott@nbt.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Is Carbetocin as least as effective as Syntometrine, and more effective than Syntocinon, at preventing post partum haemorrhage after vaginal birth?
    Protection of trial subjects
    Labouring women are a vulnerable population. Plans for recruitment were developed in line with Royal College of Obstetrician and Gynaecologist Clinical Governance Advice 6a (August 2010): “Obtaining valid consent to participate in research while in labour”. To try and ensure that patients had as much time as possible to consider the study and whether they would like to participate, information was given to patients antenatally at ~20 weeks gestation when they attended antenatal clinic for their routine anomaly scan. If a woman was invited to take part a sticker was placed in the front of the notes. This sticker helped avoid situations in which patients who did not want to participate were not repeatedly asked. In labour, midwives were an advocate for the patient and acted as their “gatekeeper”, having established the patient’s birth preferences. Exclusion criteria was in place (e.g. stillbirth, prisoners, women aged under 18years, those unable to read and comprehend the study) to ensure that the most vulnerable were not recruited as it was felt not appropriate.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 5717
    Worldwide total number of subjects
    5717
    EEA total number of subjects
    5717
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    5717
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Opportunistically invited women from 20 weeks gestation onwards. This was "opportunistic", as it mainly involved women who happened to attend the hospital antenatal ward, antenatal clinic, and Maternity Assessment Unit in their last few weeks of pregnancy.

    Pre-assignment
    Screening details
    		 Screening was completed by a research midwife. Inclusion criteria; <18 years old at the time of birth, Vaginal birth (spontaneous/instrumental), singleton pregnancy, any gestation.

    Period 1
    Period 1 title
    Overall Trial Period (All trial) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Carbetocin
    Arm description
    		 This group were randomised to receive Carbetocin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carbetocin
    Investigational medicinal product code
    ATC H01BB03 PR1
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100μg given once. Formula; (2S)1[(3S,6S,9S,12S,15S)12[(2S)butan2yl]9(2carbamoylethyl)6(carbamoylmethyl)15[(4hydroxyphenyl)methyl]16methy l5,8,11,14,17pentaoxo1thia4,7,10,13,16pentazacycloicosane3carbonyl]N[(1S)1(carbamoylmethylcarbamoyl)3methylbutyl]pyrrolidine2carboxamide

    Arm title
    		 Syntocinon
    Arm description
    		 The group was randomised to receive Syntocinon
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Syntocinon
    Investigational medicinal product code
    ATC H01BB02 PR2
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10iU. Given once.

    Arm title
    		 Syntometrine
    Arm description
    		 The group was randomised to receive Syntometrine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Syntometrine
    Investigational medicinal product code
    ATC G02AC PR3
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    5iU given once. Formula; c19h23n3o2

    Number of subjects in period 1
    		Carbetocin Syntocinon Syntometrine
    Started
    1909
    1896
    1912
    Completed
    1909
    1896
    1912

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial Period (All trial)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Period (All trial) Total
    Number of subjects
    		 5717 5717
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5717 5717
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5717 5717
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Carbetocin
    Reporting group description
    		 This group were randomised to receive Carbetocin

    Reporting group title
    Syntocinon
    Reporting group description
    		 The group was randomised to receive Syntocinon

    Reporting group title
    Syntometrine
    Reporting group description
    		 The group was randomised to receive Syntometrine

    Subject analysis set title
    PP Population - Carbetocin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In supplementary analyses we report results per protocol (PP; i.e. participants who were randomised, remained eligible, received uterotonic which first randomised to, analysed according to uterotonic received).

    Subject analysis set title
    PP Population - Syntocinon
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In supplementary analyses we report results per protocol (PP; i.e. participants who were randomised, remained eligible, received uterotonic which first randomised to, analysed according to uterotonic received).

    Subject analysis set title
    PP Population - Syntometrine
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In supplementary analyses we report results per protocol (PP; i.e. participants who were randomised, remained eligible, received uterotonic which first randomised to, analysed according to uterotonic received).

    Primary: Requirement for additional uterotonic drug - (mITT population)

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    End point title
    		 Requirement for additional uterotonic drug - (mITT population)
    End point description
    End point type
    Primary
    End point timeframe
    From the IMP administration to discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: Number
    1909
    1896
    1912
    Attachments
    		 Logistic Regression
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Statistical analysis description
    The primary outcome variable is the need for additional uterotonic drugs. An omnibus test for differences in the proportions needing (not needing) additional uterotonic drugs with be examined using the chi-square test of association.
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.004
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.93
    Notes
    [1] - o Superiority comparison between Syntometrine and Syntocinon o Superiority comparison between Carbetocin and Syntocinon o Non-inferiority comparison between Carbetocin and Syntometrine
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Statistical analysis description
    The primary outcome variable is the need for additional uterotonic drugs. An omnibus test for differences in the proportions needing (not needing) additional uterotonic drugs with be examined using the chi-square test of association.
    Comparison groups
    Syntocinon v Syntometrine
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.91
    Notes
    [2] - o Superiority comparison between Syntometrine and Syntocinon o Superiority comparison between Carbetocin and Syntocinon o Non-inferiority comparison between Carbetocin and Syntometrine
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Statistical analysis description
    The primary outcome variable is the need for additional uterotonic drugs. An omnibus test for differences in the proportions needing (not needing) additional uterotonic drugs with be examined using the chi-square test of association.
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.78
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.2
    Notes
    [3] - o Superiority comparison between Syntometrine and Syntocinon o Superiority comparison between Carbetocin and Syntocinon o Non-inferiority comparison between Carbetocin and Syntometrine

    Primary: Requirement for additional uterotonic drug - (PP population)

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    End point title
    		 Requirement for additional uterotonic drug - (PP population)
    End point description
    End point type
    Primary
    End point timeframe
    From the IMP administration to discharge
    End point values
    		 PP Population - Carbetocin PP Population - Syntocinon PP Population - Syntometrine
    Number of subjects analysed
    1885
    1869
    1912
    Units: Number
    359
    359
    293
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    PP Population - Carbetocin v PP Population - Syntometrine
    Number of subjects included in analysis
    3797
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.004
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.93
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    PP Population - Syntocinon v PP Population - Syntometrine
    Number of subjects included in analysis
    3781
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.92
    Statistical analysis title
    		 Oxytocin v Carbetocin
    Comparison groups
    PP Population - Syntocinon v PP Population - Carbetocin
    Number of subjects included in analysis
    3754
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.89
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.19

    Secondary: Median Blood Loss (ml)

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    End point title
    		 Median Blood Loss (ml)
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of IMP until discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: milliequivalent(s)/millilitre
        number (not applicable)
    500
    500
    483
    No statistical analyses for this end point

    Secondary: Estimated Blood Loss ≥500ml

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    End point title
    		 Estimated Blood Loss ≥500ml
    End point description
    End point type
    Secondary
    End point timeframe
    IMP administration to discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: millicurie(s)/millilitre
        number (not applicable)
    961
    949
    483
    Attachments
    		 Logistic Regression
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.16
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.04
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.05
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.12

    Secondary: Estimated Blood Loss ≥ 1000ml

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    End point title
    		 Estimated Blood Loss ≥ 1000ml
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of IMP until discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: millicurie(s)/millilitre
        number (not applicable)
    330
    355
    352
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.37
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.27
    Statistical analysis title
    		 Syntometrine v Synocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.82
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.16
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.3

    Secondary: Estimated Blood Loss ≥ 2000ml

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    End point title
    		 Estimated Blood Loss ≥ 2000ml
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of IMP until discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: millicurie(s)/millilitre
        number (not applicable)
    56
    74
    59
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Syntometrine v Carbetocin
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.79
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.53
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.11
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.9

    Secondary: Blood Transfusion

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    End point title
    		 Blood Transfusion
    End point description
    End point type
    Secondary
    End point timeframe
    IMP administration until discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: Adverse Events
    54
    58
    51
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Syntometrine v Carbetocin
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.09
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.34
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntocinon v Syntometrine
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.27
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.58

    Secondary: Manual removal of placenta

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    End point title
    		 Manual removal of placenta
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of IMP until discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: Yes/No
    57
    43
    49
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Syntometrine v Carbetocin
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.63
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.26
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.72
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Syntocinon v Carbetocin
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.13

    Secondary: Other Surgical/mechanical methods to treat PPH

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    End point title
    		 Other Surgical/mechanical methods to treat PPH
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of IMP until discharge
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: Number of Incidence
    42
    58
    38
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.64
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.4
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.97
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 2.1

    Secondary: Hypertension in first two postnatal hours

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    End point title
    		 Hypertension in first two postnatal hours
    End point description
    Defined as SBP ≥140mmHg or DBP ≥90mmHg in the first two postnatal hours
    End point type
    Secondary
    End point timeframe
    Administration of the IMP until two hours postnatal
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    132
    134
    233
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.51
         upper limit
    		 2.37
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.48
         upper limit
    		 2.32
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.88
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.31

    Secondary: Hypotension in first two postnatal hours

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    End point title
    		 Hypotension in first two postnatal hours
    End point description
    Defined as DBP <90mmHg in the first two postnatal hours
    End point type
    Secondary
    End point timeframe
    Administration of the IMP until2 hours postnatal
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    31
    47
    30
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.91
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.7
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntocinon v Syntometrine
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.83
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.06
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.43

    Secondary: Nausea

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    End point title
    		 Nausea
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of the IMP until 14 day follow up
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    153
    169
    458
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.98
         upper limit
    		 4.4
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntocinon v Syntometrine
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.67
         upper limit
    		 3.9
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.41

    Secondary: Vomiting

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    End point title
    		 Vomiting
    End point description
    Vomiting in those not already vomiting in labour
    End point type
    Secondary
    End point timeframe
    Administration of IMP until 14 day follow up
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    91
    92
    337
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.36
         upper limit
    		 5.45
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntocinon v Syntometrine
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 5.35
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.91
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.37

    Secondary: Headache

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    End point title
    		 Headache
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of the IMP to 14 days follow up
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    28
    26
    65
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Syntocinon v Carbetocin
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.51
         upper limit
    		 3.7
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntocinon v Syntometrine
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 4.02
    Statistical analysis title
    		 Synotcinon v Carbetocin
    Comparison groups
    Syntocinon v Carbetocin
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.6

    Secondary: Dizziness

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    End point title
    		 Dizziness
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of the IMP until 14 day follow up
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    123
    163
    188
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 2.01
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.45
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Syntocinon v Carbetocin
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.74

    Secondary: Abdominal pain

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    End point title
    		 Abdominal pain
    End point description
    End point type
    Secondary
    End point timeframe
    Administration of the IMP until 14 days follow up
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    99
    129
    162
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Carbetocin v Syntometrine
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.31
         upper limit
    		 2.19
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntometrine v Syntocinon
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.62
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Carbetocin v Syntocinon
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.75

    Secondary: Self-reported ability to bond with/care forbaby infirst two postnatal hours

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    End point title
    		 Self-reported ability to bond with/care forbaby infirst two postnatal hours
    End point description
    End point type
    Secondary
    End point timeframe
    Administration to the IMP up to two hours postnatal
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: number of incidence
    56
    83
    160
    Statistical analysis title
    		 Syntometrine v Carbetocin
    Comparison groups
    Syntometrine v Carbetocin
    Number of subjects included in analysis
    3821
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.22
         upper limit
    		 4.13
    Statistical analysis title
    		 Syntometrine v Syntocinon
    Comparison groups
    Syntocinon v Syntometrine
    Number of subjects included in analysis
    3808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.52
         upper limit
    		 2.62
    Statistical analysis title
    		 Syntocinon v Carbetocin
    Comparison groups
    Syntocinon v Carbetocin
    Number of subjects included in analysis
    3805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 2.15

    Secondary: Mean EQ-5D Utility Score: all returned questionaires

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    End point title
    		 Mean EQ-5D Utility Score: all returned questionaires
    End point description
    Standard deviations not given
    End point type
    Secondary
    End point timeframe
    Conducted at recruitment, Day 1 and Day 14
    End point values
    		 Carbetocin Syntocinon Syntometrine
    Number of subjects analysed
    1909
    1896
    1912
    Units: EQ-5D Index Scores
    arithmetic mean (standard deviation)
        Antenatal
    0.8115 ± .16954
    0.8107 ± .17524
    0.8104 ± .16954
        Day One
    0.7578 ± .17879
    0.7553 ± 17460
    0.7470 ± .17879
        Day 14
    0.8998 ± .12427
    0.9031 ± .12520
    0.8910 ± .12556
        Participants with a complete EQ-5D dataset
    0.8995 ± 0
    0.9034 ± 0
    0.8995 ± 0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Event: Report to Sponsor and CI within 24 hours Suspected Unexpected Serious Adverse Reaction: Record, assess and report to Sponsor and CI within 24 hours. Report to Reg Authorities within 7 (if fatal/life threatening) / 15 days.
    Adverse event reporting additional description
    Please note that many Non-Serious Adverse Events were routinely collected and have been reported as secondary outcome measures. Please refer to End Points for further details. Only those AEs not collected as secondary outcomes have been listed here here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Carbetocin
    Reporting group description
    		 This group were randomised to receive Carbetocin

    Reporting group title
    Syntocinon
    Reporting group description
    		 The group was randomised to receive Syntocinon

    Reporting group title
    Syntometrine
    Reporting group description
    		 The group was randomised to receive Syntometrine

    Serious adverse events
    		 Carbetocin Syntocinon Syntometrine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    63 / 1885 (3.34%)
    73 / 1869 (3.91%)
    63 / 1884 (3.34%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Tachycardia
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    0 / 1885 (0.00%)
    1 / 1869 (0.05%)
    0 / 1884 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Laporatomy
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    0 / 1885 (0.00%)
    0 / 1869 (0.00%)
    1 / 1884 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Postpartum haemorrhage
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    53 / 1885 (2.81%)
    68 / 1869 (3.64%)
    57 / 1884 (3.03%)
         occurrences causally related to treatment / all
    17 / 53
    15 / 68
    10 / 57
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Stroke
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    2 / 1885 (0.11%)
    1 / 1869 (0.05%)
    0 / 1884 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    2 / 1885 (0.11%)
    2 / 1869 (0.11%)
    1 / 1884 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 1885 (0.11%)
    1 / 1869 (0.05%)
    1 / 1884 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    1 / 1885 (0.05%)
    0 / 1869 (0.00%)
    0 / 1884 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Numbness
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    0 / 1885 (0.00%)
    1 / 1869 (0.05%)
    1 / 1884 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    0 / 1885 (0.00%)
    0 / 1869 (0.00%)
    1 / 1884 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy
    Additional description: 'Occurrences causally related to treatment number', refers to Severe Adverse Events that were deemed to have been 'possibly' related to study drug.
         subjects affected / exposed
    0 / 1885 (0.00%)
    0 / 1869 (0.00%)
    1 / 1884 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Carbetocin Syntocinon Syntometrine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 1885 (0.11%)
    7 / 1869 (0.37%)
    1 / 1884 (0.05%)
    General disorders and administration site conditions
    Cough
    Additional description: Coughing/tickly chest
         subjects affected / exposed
    0 / 1885 (0.00%)
    0 / 1869 (0.00%)
    1 / 1884 (0.05%)
         occurrences all number
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 1885 (0.05%)
    0 / 1869 (0.00%)
    0 / 1884 (0.00%)
         occurrences all number
    1
    0
    0
    Fainting
         subjects affected / exposed
    0 / 1885 (0.00%)
    4 / 1869 (0.21%)
    1 / 1884 (0.05%)
         occurrences all number
    0
    4
    1
    Ear and labyrinth disorders
    Crackling Sensation
         subjects affected / exposed
    1 / 1885 (0.05%)
    0 / 1869 (0.00%)
    0 / 1884 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Twitch
         subjects affected / exposed
    1 / 1885 (0.05%)
    1 / 1869 (0.05%)
    0 / 1884 (0.00%)
         occurrences all number
    1
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2015
    Amendment 1 1. Sending post-natal follow up questionnaire to participants by post, if not able to contact participant by telephone 2. Prolongation of total predicted recruitment period to 24 months (from 16-18 months) 3. Recruiting participants from 20+ weeks gestation (instead of 36+ weeks), providing the woman feels she has had adequate time to read and consider information contained within the Patient Information Leaflet).
    18 Aug 2015
    Amendment 2 Alteration of exclusion criteria Alteration of intrapartum blood pressure threshold at which participant is withdrawn from study Addition of epilepsy as an exclusion criterion Addition of The Great Western Hospital, Swindon, as a participating site
    19 Oct 2015
    Amendment 3 Slight alteration of the phrasing of one part of Patient Information Sheet to ensure that the leaflet also accurately reflects “routine clinical care” at University Hospitals Bristol NHS Foundation Trust. Change in the name of Principal Investigator at North Bristol NHS Trust, to cover a period of absence for maternity leave.
    15 Sep 2016
    Amendment 4 Change to the recruitment strategy to include the use of participant identification centres (PIC) Addition of Weston Area Health NHS Trust as a PIC for University Hospitals Bristol
    18 Apr 2018
    Amendment 5 Change in the name of principal Investigator at Royal United Hospitals, Bath. Change to the Patient Information Sheet and Patient Information Leaflet to reflect that the injection can be also given in the arm. Addition of more information to the protocol with regards to the statistical analysis plan, health economics evaluation, variables and secondary outcomes. The use of oxytocin infusion to augment or induce labour and the administration of terbutaline during the 2nd stage of labour has been changed from secondary outcomes to variables.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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