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    Clinical Trial Results:
    Maternal and fetal serum concentrations of magnesium and maternal surveillance after administration of a 6 g bolus dose of magnesium sulfate (MgSO4) to women with imminent preterm delivery

    Summary
    EudraCT number
    		 2017-004898-14
    Trial protocol
    		 SE  
    Global end of trial date
    29 Jan 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    5.1-2018-12254, 2018-02-08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Västra Götalandsregionen, Sahlgrenska Universitetssjukhuset,
    Sponsor organisation address
    Diagnosvägen 15, Gothenburg, Sweden, 41685
    Public contact
    Research Support Office, Gothia Forum, gothia.forum@vgregion.se
    Scientific contact
    Research Support Office, Gothia Forum, gothia.forum@vgregion.se
    Sponsor organisation name
    Västra Götalandsregionen, Sahlgrenska Universitetssjukhuset,
    Sponsor organisation address
    Diagnosvägen 15, Gothenburg, Sweden, 41685
    Public contact
    Ylva Carlsson, , Västra Götalandsregionen, Sahlgrenska Universitetssjukhuset, +46 313436286, ylva.carlsson@vgregion.se
    Scientific contact
    Ylva Carlsson, Västra Götalandsregionen, Sahlgrenska Universitetssjukhuset, +46 313436286, ylva.carlsson@vgregion.se
    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
    29 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Utvärdera av MgSO4 som bolusdos - fastställa så att önskad peak-koncentration av Magnesium nås i moderns blod samt utvärdera nivån av Magnesium hos barnet. Dessutom notera eventuella biverkningar hos mor och därmed övervakningsbehov inför framtiden och eventuella biverkningar hos barnet. Maternal and fetal serum concentrations of magnesium ande maternal surveillance after administration of a 6 g bolus dose of magnesium sulfate (MgSO4) to women with imminent preterm delivery
    Protection of trial subjects
    The study is performed in accordance with the directions from the Swedish Medical Agency and the Ethics committee. Monitoring has been made accordingly, by an independent monitor.
    Background therapy
    		 Magnesium Sulfate 50%w/v Solution for Injection 6g bolus dose given once, may be repeated once after 24 hours.
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    02 Nov 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
    Sweden: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Sahlgrenska University Hospital Östra, special delivery ward 314, period: 181102-191120. No serious adverse advent: 1 Consent withdrawn by subject: 1

    Pre-assignment
    Screening details
    		 No serious adverse advent: 1 Consent withdrawn by subject: 1

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 MgSO4
    Arm description
    		 Magnesium Sulfate 50%w/v Solution for Injection 6g bolus dose during 20-30 minutes
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Magnesium Sulfate Heptahydrate 5g/ 10ml 2.5g/ 5ml 1g/ 2ml
    Investigational medicinal product code
    ATC code: A12CC 02.
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use, Intravenous bolus use
    Dosage and administration details
    6 g iv slowly during 20-30 minutes

    Number of subjects in period 1
    		MgSO4
    Started
    22
    Completed
    22

    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
    		 22 22
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Adults (18-64 years)
    		 22 22
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Decision for end of trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The trial was ended after 22 women and fetuses were given treatment. The distribution of data showed that no further recruitment would change that data in such way that any critical /serious high level of magnesium concentration would be reached.

    Subject analysis sets values
    		 Decision for end of trial
    Number of subjects
    22
    Age categorical
    Units: Subjects
        In utero
    22
        Preterm newborn infants (gestational age < 37 wks)
    22
        Adults (18-64 years)
    22
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    22
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    MgSO4
    Reporting group description
    		 Magnesium Sulfate 50%w/v Solution for Injection 6g bolus dose during 20-30 minutes

    Subject analysis set title
    Decision for end of trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The trial was ended after 22 women and fetuses were given treatment. The distribution of data showed that no further recruitment would change that data in such way that any critical /serious high level of magnesium concentration would be reached.

    Primary: magnesium concentration levels

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    End point title
    		 magnesium concentration levels
    End point description
    The trial was ended after 22 women and fetuses were given treatment. The distribution of data showed that no further recruitment would change that data in such way that any critical /serious high level of magnesium concentration would be reached.
    End point type
    Primary
    End point timeframe
    2019-dec-29-2020-jan-29
    End point values
    		 MgSO4 Decision for end of trial
    Number of subjects analysed
    21
    21
    Units: mmol/l
        arithmetic mean (standard deviation)
    2.19 ± 0.43
    1.03 ± 0.09
    Statistical analysis title
    		 Descriptive
    Statistical analysis description
    Data analysis was done using the GraphPad Prism 8 version 8.1.1. T-test, Mann-Whitney test and simple linear regression analysis were applied as appropriate. Pearson’s test was used for normal distribution analysis. A two tailed p-value <0.05 was considered statistically significant. Add Spearmen rank or linear regression
    Comparison groups
    MgSO4 v Decision for end of trial
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Data analysis was done using the GraphPad Prism 8 version 8.1.1. T-test, Mann-Whitney test and simple linear regression analysis were applied as appropriate. Pearson’s test was used for normal distribution analysis. A two tailed p-value <0.05 was considered statistically significant. Add Spearmen rank or linear regression

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    181102-201229
    Adverse event reporting additional description
    1 non-serious adverse events. I person was briefly (<5 minutes) hard do to contact/communicate with during infusion. Blood pressure and pulse as well as saturation was stable, magnesium concentrations was within normal range for the mother; CTG was normal, no cramps occurred. The event was judged as not dependent upon the medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    MgSO4
    Reporting group description
    		 Magnesium Sulfate 50%w/v Solution for Injection 6g bolus dose during 20-30 minutes

    Serious adverse events
    		 MgSO4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 MgSO4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    Social circumstances
    hard to communicate
    Additional description: One person was hard to talk to/communicate a few minutes during infusion. All vital parameters for both mother and child was normal as well as serum concentrations for magnesium and the event was judged to be not connected to the infusion.
         subjects affected / exposed
    1 / 22 (4.55%)
         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.
    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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