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    Clinical Trial Results:
    HEPARINA DE BAJO PESO MOLECULAR (HBPM) para la prevención de complicaciones derivadas de la insuficiencia placentaria en las pacientes de riesgo sin trombofilia: ensayo clínico multicéntrico randomizado

    Summary
    EudraCT number
    		 2010-023597-39
    Trial protocol
    		 ES  
    Global end of trial date
    21 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2021
    First version publication date
    14 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOPPE-Trial
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, +34 934894779, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Academic Research Organization, VHIR, aro@vhir.org
    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
    21 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of treating patients in risk of maternofetal complications
    Protection of trial subjects
    Blood analytics were done on 1st, 2nd and 3rt trimester of gestation. In the HBPM griup, an additional analytics was done one week after starting treatment. Ecographies were done at 20 and 30-34 weeks of gestation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 278
    Worldwide total number of subjects
    278
    EEA total number of subjects
    278
    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)
    278
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 278
    Number of subjects completed
    		 278

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The proposal intervention (subcutaneous administration) did not make possible to blind the study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LMWH administration
    Arm description
    		 Low Molecular Weight Heparin administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    Heparin
    Investigational medicinal product code
    Other name
    Sodium Enoxaparin, Clexane
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Daily dose of 40 mg (patients under 80Kg) or 60 mg (patients over 80Kg body weight at inclusion time). Dose was adjusted over the period, if necessary

    Arm title
    		 Control no treatment
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		LMWH administration Control no treatment
    Started
    144
    134
    Completed
    108
    116
    Not completed
    36
    18
         Lost to follow-up
    31
    18
         Protocol deviation
    5
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 278 278
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 278 278
    Gender categorical
    Units: Subjects
        Female
    		 278 278
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    LMWH administration
    Reporting group description
    		 Low Molecular Weight Heparin administration

    Reporting group title
    Control no treatment
    Reporting group description
    		 -

    Primary: Incidence of gestational complications

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    End point title
    		 Incidence of gestational complications
    End point description
    End point type
    Primary
    End point timeframe
    End of gestations
    End point values
    		 LMWH administration Control no treatment
    Number of subjects analysed
    144
    134
    Units: percent
        number (not applicable)
    32.0
    34.7
    Statistical analysis title
    		 Overall complications
    Comparison groups
    LMWH administration v Control no treatment
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.64
    Method
    		 t-test, 2-sided
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.85

    Secondary: Preeclampsia incidence

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    End point title
    		 Preeclampsia incidence
    End point description
    End point type
    Secondary
    End point timeframe
    All the study
    End point values
    		 LMWH administration Control no treatment
    Number of subjects analysed
    144
    134
    Units: percent
        number (not applicable)
    7.64
    9.70
    Statistical analysis title
    		 Preeclampsia
    Comparison groups
    LMWH administration v Control no treatment
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.54
    Method
    		 t-test, 2-sided
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.78

    Secondary: RCIU incidence

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    End point title
    		 RCIU incidence
    End point description
    End point type
    Secondary
    End point timeframe
    All the study
    End point values
    		 LMWH administration Control no treatment
    Number of subjects analysed
    144
    134
    Units: percent
        number (not applicable)
    12.5
    11.2
    Statistical analysis title
    		 RCIU incidence
    Comparison groups
    LMWH administration v Control no treatment
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.736
    Method
    		 t-test, 2-sided
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 2.35

    Secondary: Small foetus

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    End point title
    		 Small foetus
    End point description
    End point type
    Secondary
    End point timeframe
    All the study
    End point values
    		 LMWH administration Control no treatment
    Number of subjects analysed
    144
    134
    Units: percent
        number (not applicable)
    10.42
    11.19
    Statistical analysis title
    		 Small foetus
    Comparison groups
    LMWH administration v Control no treatment
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.834
    Method
    		 t-test, 2-sided
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.97

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 278 (2.88%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Intracranial venous thromboembolism
         subjects affected / exposed
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    HELLP syndrome
         subjects affected / exposed
    3 / 278 (1.08%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Thromboembolectomy
         subjects affected / exposed
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    UCI ingress
         subjects affected / exposed
    1 / 278 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    2 / 278 (0.72%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 278 (0.72%)
    Blood and lymphatic system disorders
    Epistaxis
         subjects affected / exposed
    1 / 278 (0.36%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 278 (0.36%)
         occurrences all number
    1

    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.
    Double blinding was not possible due to nature of intervention. A 19% loss of adherence could mak some results. A follow-up of mothers and infants is necessary to evaluate long-term effects of treatment on their health.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33472201
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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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