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    Clinical Trial Results:
    A Randomised Trial of First dose of Misoprostol Administration at Home or in Hospital for Medical Abortion between 12-22 gestational weeks - The PRIMA (PRIMing At home) Trial.

    Summary
    EudraCT number
    		 2018-000964-27
    Trial protocol
    		 SE  
    Global end of trial date
    28 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Feb 2025
    First version publication date
    27 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WP2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    Nobels väg 6, Solna, Sweden, 17165
    Public contact
    Kristina Gemzell Danielsson, Karolinska Institutet, 46 08517700002128, kristina.gemzell@ki.se
    Scientific contact
    Kristina Gemzell Danielsson, Karolinska Institutet, 46 08517700002128, kristina.gemzell@ki.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
    01 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the number of patients who are treated as day care patients in medical abortion from day 85 to day 153 of gestation when administrated the first dose of misoprostol at home or in the clinic
    Protection of trial subjects
    All participants were given oral and written information about the study, had the opportunity to ask questions, and signed written informed consent before random assignment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2019
    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
    Sweden: 457
    Worldwide total number of subjects
    457
    EEA total number of subjects
    457
    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)
    457
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 People who sought induced abortion care at the abortion clinic of the respective study site were asked to participate if they fulfilled the inclusion criteria and had no exclusion criteria.

    Pre-assignment
    Screening details
    		 People who sought induced abortion care at the abortion clinic of the respective study site were asked to participate if they fulfilled the inclusion criteria and had no exclusion criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The allocation groups were unmasked for data entrants. While performing the statistical analysis, the groups were masked to the researcher.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Home - use
    Arm description
    		 Home administration of the first dose of misoprostol
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cytotec
    Investigational medicinal product code
    Other name
    misoprostol
    Pharmaceutical forms
    Vaginal tablet
    Routes of administration
    Vaginal use
    Dosage and administration details
    Between 24–48 h after taking mifepristone, the participants in the home treatment group administered the first dose of misoprostol (800 μg) deep vaginally at home, together with pain medication, and returned to the hospital 2 h later to receive the remaining treatment in hospital.

    Arm title
    		 Hospital
    Arm description
    		 Hospital administration of the first dose of misoprostol
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Home - use Hospital
    Started
    220
    215
    Completed
    214
    215
    Not completed
    6
    0
         Protocol deviation
    6
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 457 participants were initially enrolled - 228 assigned to home treatment, however 8 were excluded prior to treatment - 229 were assigned to hospital treatment but 14 were excluded prior to treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Home - use
    Reporting group description
    		 Home administration of the first dose of misoprostol

    Reporting group title
    Hospital
    Reporting group description
    		 Hospital administration of the first dose of misoprostol

    Reporting group values
    		 Home - use Hospital Total
    Number of subjects
    		 220 215 435
    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 (standard deviation)
    		 31.5 ( 6.0 ) 31.2 ( 6.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 220 215 435
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Home - use
    Reporting group description
    		 Home administration of the first dose of misoprostol

    Reporting group title
    Hospital
    Reporting group description
    		 Hospital administration of the first dose of misoprostol

    Primary: Treated as day-care patient (<9 h)

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    End point title
    		 Treated as day-care patient (<9 h)
    End point description
    End point type
    Primary
    End point timeframe
    Per protocol
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    220
    215
    Units: Participants
    156
    99
    Statistical analysis title
    		 Differences in group means with 95% confidence int
    Statistical analysis description
    We presented primary and secondary outcomes as differences in group means with 95% confidence interval (CI) for continuous variables and as differences in group percentages with 95% CI for dichotomous variables.
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.4
         upper limit
    		 34.3
    Variability estimate
    Standard deviation

    Secondary: Completed abortion rate at 24 h

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    End point title
    		 Completed abortion rate at 24 h
    End point description
    End point type
    Secondary
    End point timeframe
    Per protocol
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    219
    212
    Units: Participants
    198
    191
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.4
         upper limit
    		 5.7
    Variability estimate
    Standard deviation

    Secondary: Hours in clinic from admission to discharge

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    End point title
    		 Hours in clinic from admission to discharge
    End point description
    End point type
    Secondary
    End point timeframe
    Per protocol
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    219
    211
    Units: hour
        arithmetic mean (standard deviation)
    10.3 ( 10.8 )
    13.1 ( 12.5 )
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 -0.6
    Variability estimate
    Standard deviation

    Secondary: Induction to fetal abortion interval (min)

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    End point title
    		 Induction to fetal abortion interval (min)
    End point description
    End point type
    Secondary
    End point timeframe
    Per protocol
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    218
    211
    Units: minute
        arithmetic mean (standard deviation)
    494.1 ( 511.0 )
    493.1 ( 553.5 )
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100.1
         upper limit
    		 102
    Variability estimate
    Standard deviation

    Secondary: Number of doses of misoprostol used

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    End point title
    		 Number of doses of misoprostol used
    End point description
    The loading dose equals four tablets of misoprostol (800 μg), and the following doses equal two tablets per dose.
    End point type
    Secondary
    End point timeframe
    Per protocol
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    218
    211
    Units: number of doses
        arithmetic mean (standard deviation)
    2.92 ( 1.71 )
    2.93 ( 1.79 )
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.92
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3
    Variability estimate
    Standard deviation

    Secondary: Satisfaction with abortion treatment

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    End point title
    		 Satisfaction with abortion treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Per protocol
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    200
    188
    Units: Participants
        1 (very disappointed)
    0
    1
        2--
    0
    3
        3--
    4
    4
        4--
    25
    28
        5 (very satisfied)
    171
    152
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.078
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Preference of first misoprostol administration

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    End point title
    		 Preference of first misoprostol administration
    End point description
    End point type
    Secondary
    End point timeframe
    Per protocol
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    200
    188
    Units: Participants
        Home
    155
    96
        Hospital
    45
    92
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Pain at admission (VAS)

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    End point title
    		 Pain at admission (VAS)
    End point description
    End point type
    Secondary
    End point timeframe
    At admission
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    193
    175
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    28.4 ( 26.0 )
    5.83 ( 13.19 )
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    368
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.4
         upper limit
    		 26.7
    Variability estimate
    Standard deviation

    Secondary: Pain at abortion (VAS)

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    End point title
    		 Pain at abortion (VAS)
    End point description
    End point type
    Secondary
    End point timeframe
    At abortion
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    164
    150
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    39.7 ( 35.1 )
    39.0 ( 33.9 )
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Hospital v Home - use
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.87
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 8.3
    Variability estimate
    Standard deviation

    Secondary: Surgical interventions needed

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    End point title
    		 Surgical interventions needed
    End point description
    End point type
    Secondary
    End point timeframe
    At time of abortion
    End point values
    		 Home - use Hospital
    Number of subjects analysed
    219
    212
    Units: Participants
    14
    18
    Statistical analysis title
    		 Differences in group means
    Comparison groups
    Home - use v Hospital
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 3.3
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    08Jan2019 to 28Mar2023
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 TBU
    Dictionary version
    unk
    Reporting groups
    Reporting group title
    All study subjects.
    Reporting group description
    		 -

    Serious adverse events
    		 All study subjects.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 435 (2.76%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Bleeding
         subjects affected / exposed
    11 / 435 (2.53%)
         occurrences causally related to treatment / all
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 435 (0.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All study subjects.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    97 / 435 (22.30%)
    Pregnancy, puerperium and perinatal conditions
    Retention of products of conception and expulsion of fetus before admission
    Additional description: Retention of products of conception and expulsion of fetus before admission
         subjects affected / exposed
    27 / 435 (6.21%)
         occurrences all number
    27
    Blood and lymphatic system disorders
    Bleeding
         subjects affected / exposed
    58 / 435 (13.33%)
         occurrences all number
    58
    General disorders and administration site conditions
    Other
         subjects affected / exposed
    16 / 435 (3.68%)
         occurrences all number
    16
    Immune system disorders
    Allergy
         subjects affected / exposed
    1 / 435 (0.23%)
         occurrences all number
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    20 / 435 (4.60%)
         occurrences all number
    20

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jan 2021
    Addition of two new study sites Exact date unknown, year 2021 correct.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39216976
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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
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