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    Clinical Trial Results:
    Induction of Labour with a Foley catheter or oral Misoprostol at Term

    Summary
    EudraCT number
    		 2011-000026-30
    Trial protocol
    		 NL  
    Global end of trial date
    10 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 May 2021
    First version publication date
    09 May 2021
    Other versions
    Summary report(s)
    		 Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial

    Trial information

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    Trial identification
    Sponsor protocol code
    ABR35278
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 The Netherlands Trial Register : NTR3466
    Sponsors
    Sponsor organisation name
    AMC
    Sponsor organisation address
    Meibergdreef 9, Amsterdam, Netherlands, 1105AZ
    Public contact
    Verloskundig consortium, Academic medical centre, b.w.mol@amc.uva.nl
    Scientific contact
    Verloskundig consortium, Academic medical centre, b.w.mol@amc.uva.nl
    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
    02 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess in term pregnant women with an unfavourable cervix (Bischop score <6) the effectiveness of induction of labor with a transcervical Foley catheter or oral misoprostol
    Protection of trial subjects
    Through insurrance/ IDMC rules - not sure what this question intends
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jul 2012
    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
    Netherlands: 1859
    Worldwide total number of subjects
    1859
    EEA total number of subjects
    1859
    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)
    1859
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients with a reason for induction of labour at term where screened if they where eligible

    Period 1
    Period 1 title
    baseline period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oral misoprostol
    Arm description
    		 -
    Arm type
    		 See article

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Foley catheter
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Foley catheter
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Vaginal use
    Dosage and administration details
    See article

    Investigational medicinal product name
    misoprostol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    See article

    Number of subjects in period 1
    		Oral misoprostol Foley catheter
    Started
    932
    927
    Completed
    932
    927

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Oral misoprostol
    Reporting group description
    		 -

    Reporting group title
    Foley catheter
    Reporting group description
    		 -

    Primary: Primairy outcome for composite of neonatal asphyxia (arterial umbilical cord pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (estimated blood loss ≥1000 mL ascertained over 24 h post partum

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    End point title
    		 Primairy outcome for composite of neonatal asphyxia (arterial umbilical cord pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (estimated blood loss ≥1000 mL ascertained over 24 h post partum
    End point description
    See article
    End point type
    Primary
    End point timeframe
    inclusion period
    End point values
    		 Oral misoprostol Foley catheter
    Number of subjects analysed
    924 [1]
    921 [2]
    Units: 219
        number (not applicable)
    113
    106
    Notes
    [1] - See article
    [2] - See article
    Statistical analysis title
    		 See article
    Comparison groups
    Oral misoprostol v Foley catheter
    Number of subjects included in analysis
    1845
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.4
    Method
    		 t-test, 2-sided
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.06
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.31
    Notes
    [3] - See article

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    inclusion period untill 6 weeks after last recruitment
    Adverse event reporting additional description
    52 serious adverse events were reported: 27 in the misoprostol group and 25 in the Foley catheter group
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 unknown
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Oral misoprostol
    Reporting group description
    		 52 serious adverse events were reported: 27 in the misoprostol group and 25 in the Foley catheter group (appendix p 2). None were directly related to study procedures. 49 babies were admitted to neonatal intensive care units. Four babies died (one in the misoprostol group vs three in the Foley group): three because of lethal congenital malformations diagnosed after delivery (one vs two), and one because of asphyxia (none vs one). The mother of the child who died by asphyxia was induced because of polyhydramnios and gestational diabetes. After amniotomy, fetal bradycardia occurred, for which an emergency caesarean section was done. There was no hyperstimulation, no use of oxytocinno cord prolapse, and no blood loss. Apgar score was 1 after 1 min, 0 after 5 min, and 1 after 10 min. Arterial umbilical cord pH was 6·99, base excess –16, and venous umbilical cord pH was 7·15, base excess –7·8. The child was admitted to neonatal intensive care for whole-body cooling. MRI 5 days after bbirth

    Serious adverse events
    		 Oral misoprostol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1845 (0.05%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Product issues
    See table 3, appendix p2
    Additional description: see table 3, appendix p2
         subjects affected / exposed
    1 / 1845 (0.05%)
         occurrences causally related to treatment / all
    0 / 1845
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Oral misoprostol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1845 (0.05%)
    Product issues
    see appendix article
    Additional description: see appendix published artikel
         subjects affected / exposed
    1 / 1845 (0.05%)
         occurrences all number
    1845

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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