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    Clinical Trial Results:
    Sulfato de magnesio en pauta continua versus discontinua en la conducta expectante de la preeclampsia grave: ensayo clínico aleatorizado

    Summary
    EudraCT number
    		 2011-002095-17
    Trial protocol
    		 ES  
    Global end of trial date
    30 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Nov 2021
    First version publication date
    18 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MAGSPET
    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
    Anna Suy Franch, VHIR, 34 9327490254954, asuy@vhebron.net
    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 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether continuous administration of magnesium sulfate prolongs pregnancy more days compared to discontinuous administration
    Protection of trial subjects
    During the course of the study, the United States Food and Drug Administration (FDA) alerted against prolonged use (more than 5-7 days) of magnesium sulfate, due to concern about fetal and neonatal bone demineralization. However, in these cases magnesium sulfate was used as tocolytic treatment, and prenatal exposure was longer (9.6 weeks) and higher (total maternal dose of 3700 g) than in our study. Spanish Agency of Medicines and Medical Devices (AEMPS) was informed about this alert, and confirmed to continue with the study.
    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: 95
    Worldwide total number of subjects
    95
    EEA total number of subjects
    95
    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)
    95
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at Hospital Vall Hebron (Barcelona)

    Pre-assignment
    Screening details
    		 The inclusion criteria were pregnant women 18 years of age or older, gestational age between 24 weeks 0 days and 33 weeks 6 days, diagnosed with severe preeclampsia and suitable for expectant management after 24 hours of treatment with intravenous magnesium sulfate.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Continuous MgSulfate
    Arm description
    		 Continuous treatment: keeping magnesium sulfate perfusion (1-1.5 g/h) to maintain a serum concentration of 4.8 to 9.6 mg/dL until 24 to 48 hours postpartum.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Magnesium sulfate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients were treated with intravenous magnesium sulfate according to Zuspan regimen (4 g loading dose, followed by an infusion of 1 g/h) up to 24 hours. After randomization, women were allocated to one of two groups; continuous or discontinuous

    Arm title
    		 Discontinuous MgSulfate
    Arm description
    		 Discontinuous treatment: stopping magnesium sulfate until any indication of delivery. Magnesium sulfate (4 g loading dose, followed by an infusion of 1 g/h) was reinitiated before delivery until 24 to 48 hours postpartum
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Magnesium sulfate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients were treated with intravenous magnesium sulfate according to Zuspan regimen (4 g loading dose, followed by an infusion of 1 g/h) up to 24 hours. After randomization, women were allocated to one of two groups; continuous or discontinuous

    Number of subjects in period 1
    		Continuous MgSulfate Discontinuous MgSulfate
    Started
    48
    47
    Completed
    45
    47
    Not completed
    3
    0
         Consent withdrawn by subject
    2
    -
         Lost to follow-up
    1
    -

    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
    		 95 95
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 34.2 (30.7 to 37.4) -
    Gender categorical
    Units: Subjects
        Female
    		 95 95
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Continuous MgSulfate
    Reporting group description
    		 Continuous treatment: keeping magnesium sulfate perfusion (1-1.5 g/h) to maintain a serum concentration of 4.8 to 9.6 mg/dL until 24 to 48 hours postpartum.

    Reporting group title
    Discontinuous MgSulfate
    Reporting group description
    		 Discontinuous treatment: stopping magnesium sulfate until any indication of delivery. Magnesium sulfate (4 g loading dose, followed by an infusion of 1 g/h) was reinitiated before delivery until 24 to 48 hours postpartum

    Primary: Days of delivery

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    End point title
    		 Days of delivery
    End point description
    Primary end point is the interval, in days, between inclusion in the study and delivery, between continuous and discontinuous treatment groups
    End point type
    Primary
    End point timeframe
    All the study
    End point values
    		 Continuous MgSulfate Discontinuous MgSulfate
    Number of subjects analysed
    45
    47
    Units: day
        arithmetic mean (full range (min-max))
    4 (2 to 7)
    5 (3 to 9)
    Statistical analysis title
    		 Delivary day
    Comparison groups
    Continuous MgSulfate v Discontinuous MgSulfate
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.125
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Maternal complications

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    End point title
    		 Maternal complications
    End point description
    End point type
    Secondary
    End point timeframe
    All the study
    End point values
    		 Continuous MgSulfate Discontinuous MgSulfate
    Number of subjects analysed
    45
    47
    Units: number
        number (not applicable)
    9
    12
    Statistical analysis title
    		 Maternal complications
    Comparison groups
    Continuous MgSulfate v Discontinuous MgSulfate
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.622
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Newborn complications

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    End point title
    		 Newborn complications
    End point description
    End point type
    Secondary
    End point timeframe
    All the study
    End point values
    		 Continuous MgSulfate Discontinuous MgSulfate
    Number of subjects analysed
    45 [1]
    47 [2]
    Units: Number
        number (not applicable)
    17
    19
    Notes
    [1] - They were actually 52 newborn in this group
    [2] - There were actually 54 newborn in this group
    Statistical analysis title
    		 Newborn complications
    Comparison groups
    Continuous MgSulfate v Discontinuous MgSulfate
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.786
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Continuous
    Reporting group description
    		 -

    Reporting group title
    Discontinuous
    Reporting group description
    		 -

    Serious adverse events
    		 Continuous Discontinuous
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 47 (6.38%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ventriculitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bilateral pulmonary embolism
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Continuous Discontinuous
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 45 (60.00%)
    33 / 47 (70.21%)
    Pregnancy, puerperium and perinatal conditions
    Uterine contractions during pregnancy
         subjects affected / exposed
    4 / 45 (8.89%)
    8 / 47 (17.02%)
         occurrences all number
    4
    8
    Vulvar pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Genital herpes
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Vaginal bleeding
         subjects affected / exposed
    2 / 45 (4.44%)
    3 / 47 (6.38%)
         occurrences all number
    2
    3
    Vaginitis
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 47 (6.38%)
         occurrences all number
    1
    3
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    Neck pain
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 47 (6.38%)
         occurrences all number
    1
    3
    Inferior extremity sensibility loss
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Suprapubic pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Fever
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Venous access haematoma
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Lumbar pain
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Hot flush
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Submaxilitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Tracheobronchitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 45 (8.89%)
    0 / 47 (0.00%)
         occurrences all number
    4
    0
    Cardiac disorders
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Subacute ischaemic stroke
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Vasovagal syncope
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Ventriculitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 45 (8.89%)
    8 / 47 (17.02%)
         occurrences all number
    4
    8
    Phlebitis
         subjects affected / exposed
    5 / 45 (11.11%)
    8 / 47 (17.02%)
         occurrences all number
    5
    8
    Hyperglycaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Esophageal reflux
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 47 (8.51%)
         occurrences all number
    2
    4
    Rectal haematoma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Palmar pruritus
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Urticarial dermatitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Acute renal failure
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute upper respiratory infection
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Urinary tract infection
         subjects affected / exposed
    12 / 45 (26.67%)
    13 / 47 (27.66%)
         occurrences all number
    12
    13
    Listeriosis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3

    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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