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    Clinical Trial Results:
    A feasibility study investigating pravastatin for the prevention of preterm birth in women

    Summary
    EudraCT number
    2017-005021-21
    Trial protocol
    GB  
    Global end of trial date
    31 Oct 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Feb 2021
    First version publication date
    22 Feb 2021
    Other versions
    Summary report(s)
    PIPIN REPORT 23DEC2020

    Trial information

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    Trial identification
    Sponsor protocol code
    PIPIN
    Additional study identifiers
    ISRCTN number
    ISRCTN82984919
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Ethics: 18/ES/0007, Sponsors references: AC17099, CSO Funders reference: TCS/18/30
    Sponsors
    Sponsor organisation name
    The University of Edinburgh & Lothian Health Board
    Sponsor organisation address
    ACCORD OFFICE, QMRI, 47 Little France Cresent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Sonia Whyte, University of Edinburgh, +44 131 242 2693, sonia.whyte@ed.ac.uk
    Scientific contact
    Sonia Whyte, University of Edinburgh, +44 131 242 2693, sonia.whyte@ed.ac.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
    30 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Feasibility study: This study is testing whether women between 28+0 and 35+6 weeks pregnant who come to hospital with signs and/or symptoms of preterm labour would be willing to take a medication (pravastatin) or placebo in a blinded fashion for 7 days.
    Protection of trial subjects
    Participants were offered a information by a member of their clinical care team at the time of presentation. Women presenting with sign of preterm labour are often anxious and consideration was provided to ensure that they had time to consider participation. Whilst the nature of the intervention is time-critical, they will of course be offered as long as required to consider participation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Mar 2018
    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: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Seven women were recruited from a single UK participating site. Women were identified in an antenatal care setting after they had presented with symptoms of preterm labour. Recruitment commenced 03rd August 2018 and the last patient visit was 29th November 2019

    Pre-assignment
    Screening details
    Patient eligibility was assessed by research staff, following identification of patients by clinical staff. Of the 214 patients screened, 35 (16%; 95% CI 11.7-22.0) were found to be eligible. Of the 35 eligible participants, 27 (77%) had a positive fetal fibronectin, whilst 8 (23%) had a cervical dilation ≥ 3cm.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Data analyst, Subject
    Blinding implementation details
    IMP supplies were purchased and repackaged by GMP compliant company ISG (Investigational Supplies Group) who performed over encapsulation of the pravastatin, and prepared the placebo to be used. Randomisation codes were supplied to ISG separately by an independent member of the Edinburgh Clinical Trials Team. Pharmacy were supplied with sealed unblinding envelopes. No women were unblinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Pravastatin Sodium 40mg tablets
    Arm description
    The IMP (Pravastatin 40mg) will be manufactured by: Teva UK Limited and supplied to ISG (Investigational Supplies Group) who will performed over encapsulation of the pravastatin.
    Arm type
    Active comparator

    Investigational medicinal product name
    Pravastatin Sodium 40mg tablets
    Investigational medicinal product code
    PL-00289/0409
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40mg Orally 1 dose per 24 hour period +/- 6 hours for a total of 7 days.

    Arm title
    Placebo
    Arm description
    Matching Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The principal excipient in pravastatin sodium is Lactose monohydrate 286.62mg, this will be used for the placebo. It will be formulated into a Swedish Orange hard gelatin capsule, size 00.

    Number of subjects in period 1
    Pravastatin Sodium 40mg tablets Placebo
    Started
    3
    4
    Completed
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    Pregnant women

    Reporting group values
    Overall Trial Total
    Number of subjects
    7 7
    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)
    7 7
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    23.75 (18 to 29) -
    Gender categorical
    Units: Subjects
        Female
    7 7
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Pravastatin Sodium 40mg tablets
    Reporting group description
    The IMP (Pravastatin 40mg) will be manufactured by: Teva UK Limited and supplied to ISG (Investigational Supplies Group) who will performed over encapsulation of the pravastatin.

    Reporting group title
    Placebo
    Reporting group description
    Matching Placebo

    Primary: Latency to Delivery

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    End point title
    Latency to Delivery
    End point description
    End point type
    Primary
    End point timeframe
    Time from presentation to acute care and assessment services with suspected preterm delivery to delivery itself (Latency to Delivery), as well as gestation at delivery
    End point values
    Pravastatin Sodium 40mg tablets Placebo
    Number of subjects analysed
    3
    4
    Units: days
    357
    645
    Statistical analysis title
    Methods
    Statistical analysis description
    As this is a feasibility study, the quantitative data will be presented descriptively, using appropriate summary statistics with corresponding 95% confidence intervals. Additionally, the results will be summarised separately for the two population groups, and no formal comparisons will be made.
    Comparison groups
    Pravastatin Sodium 40mg tablets v Placebo
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.05 [2]
    Method
    above not applicable
    Parameter type
    Mean difference (final values)
    Point estimate
    95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    90
         upper limit
    100
    Notes
    [1] - as above note
    [2] - not applicable for this study

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events (AE) that occur after informed consent until Estimated Date of Delivery (EDD) t + 28 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only 7 women participated numbers details are in the report attached there were no adverse events in the pravastatin group

    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.
    PIPIN is a feasibility study, and by nature, sample sizes are small, limiting clinical conclusions that can be drawn from results.
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