Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Home abortion up to 10 weeks of gestation

    Summary
    EudraCT number
    		 2013-004749-18
    Trial protocol
    		 SE  
    Global end of trial date
    30 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Feb 2023
    First version publication date
    23 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    201311LM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02191774
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska University Hospital
    Sponsor organisation address
    Solna, Stockholm, Sweden, 17176
    Public contact
    Lena Marions, Karolinska Institutet, 46 851776357, lena.marions@ki.se
    Scientific contact
    Lena Marions, Karolinska Institutet, 46 851776357, lena.marions@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
    15 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate if medical abortion at home up to 10 weeks of gestation is as safe and acceptable as was previously shown for abortions in earlier pregnancies (<9 weeks of gestation).
    Protection of trial subjects
    Participants were given instructions that emphasized the importance of contacting the clinic if any severe symptoms, which were thoroughly explained, would occur.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2014
    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: 273
    Worldwide total number of subjects
    273
    EEA total number of subjects
    273
    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)
    273
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 We enrolled women seeking medical abortion up to 70 days of gestation from November 2014 to November 2021 from Södersjukhuset, Stockholm, Karolinska University Hospital, Stockholm, and some patients were also recruited from Sahlgrenska University Hospital, Göteborg and Helsingborg Hospital.

    Pre-assignment
    Screening details
    		 The inclusion criteria were ultrasound-confirmed intrauterine pregnancy up to 70 days of gestation, willingness to administer misoprostol at home, <18 years of age, haemoglobin higher than 100 g/L, ability to understand instructions, absence of any known health problems or clinical findings that could affect the patient’s safety during the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gestational age up to 63 days
    Arm description
    		 This arm included women pregnant with a gestational age up to 63 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mifegyn
    Investigational medicinal product code
    Other name
    Mifepristone
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During the first visit to the abortion clinic, women swallowed 200 mg of mifepristone (Mifegyne, Exelgyn, Paris, France) on site.

    Investigational medicinal product name
    Misoprostol, Cytotec
    Investigational medicinal product code
    A02BB01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use, Vaginal use
    Dosage and administration details
    After first visit and administration of Mifegyn, the women were provided with 1200 mcg of misoprostol (6 tablets of 0.2 mg of misoprostol Cytotec, Pfizer, Stockholm, Sweden). They were instructed to take four tablets of misoprostol vaginally at home 24-48 hours after mifepristone administration. In case of bleeding had not started within 3 hours after misoprostol administration, women were instructed to take additional two misoprostol tablets sublingually.

    Arm title
    		 Gestational age 64-70 days
    Arm description
    		 This arm included women pregnant with a gestational age between 64 to70 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mifegyn
    Investigational medicinal product code
    Other name
    Mifepristone
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During the first visit to the abortion clinic, women swallowed 200 mg of mifepristone (Mifegyne, Exelgyn, Paris, France) on site.

    Investigational medicinal product name
    Misoprostol, Cytotec
    Investigational medicinal product code
    A02BB01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use, Vaginal use
    Dosage and administration details
    After first visit and administration of Mifegyn, the women were provided with 1200 mcg of misoprostol (6 tablets of 0.2 mg of misoprostol Cytotec, Pfizer, Stockholm, Sweden). They were instructed to take four tablets of misoprostol vaginally at home 24-48 hours after mifepristone administration. In case of bleeding had not started within 3 hours after misoprostol administration, women were instructed to take additional two misoprostol tablets sublingually.

    Number of subjects in period 1
    		Gestational age up to 63 days Gestational age 64-70 days
    Started
    112
    161
    Completed
    100
    141
    Not completed
    12
    20
         Lost to follow-up
    12
    20

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Gestational age up to 63 days
    Reporting group description
    		 This arm included women pregnant with a gestational age up to 63 days.

    Reporting group title
    Gestational age 64-70 days
    Reporting group description
    		 This arm included women pregnant with a gestational age between 64 to70 days.

    Reporting group values
    		 Gestational age up to 63 days Gestational age 64-70 days Total
    Number of subjects
    		 112 161 273
    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
        median (full range (min-max))
    		 28 (18 to 46) 29 (18 to 47) -
    Gender categorical
    Units: Subjects
        Female
    		 112 161 273

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Gestational age up to 63 days
    Reporting group description
    		 This arm included women pregnant with a gestational age up to 63 days.

    Reporting group title
    Gestational age 64-70 days
    Reporting group description
    		 This arm included women pregnant with a gestational age between 64 to70 days.

    Primary: Difference in mean complete abortion rate

    		 Close Top of page
    End point title
    		 Difference in mean complete abortion rate
    End point description
    The primary objective of the study was to study efficacy in gestations up to and above 63 days with home use of misoprostol. Efficacy was defined as a complete abortion without any need for surgical or medical intervention due to incomplete abortion or ongoing pregnancy.
    End point type
    Primary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    100
    141
    Units: Number of complete abortions
    95
    136
    Statistical analysis title
    		 Difference in mean complete abortion rate
    Statistical analysis description
    Difference in mean complete abortion rate between gestational age up to 63 days vs gestational age 64-70 days.
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.745
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Satisfied with the chosen treatment

    		 Close Top of page
    End point title
    		 Satisfied with the chosen treatment
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    77
    102
        Neutral
    5
    12
        Not agreeing with the statement
    2
    6
    No statistical analyses for this end point

    Secondary: Satisfied with the chosen treatment - Total score

    		 Close Top of page
    End point title
    		 Satisfied with the chosen treatment - Total score
    End point description
    Total score 1-5.
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Score
        arithmetic mean (standard deviation)
    4.6 ± 0.76
    4.42 ± 0.98
    Statistical analysis title
    		 Difference in mean Satisfied with the chosen treat
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.247
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Feeling calm and safe during the abortion

    		 Close Top of page
    End point title
    		 Feeling calm and safe during the abortion
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    68
    87
        Neutral
    9
    22
        Not agreeing with the statement
    7
    11
    No statistical analyses for this end point

    Secondary: Feeling calm and safe during the abortion - Total score

    		 Close Top of page
    End point title
    		 Feeling calm and safe during the abortion - Total score
    End point description
    Total score 1-5.
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Total score
        arithmetic mean (standard deviation)
    4.11 ± 0.98
    3.92 ± 1.11
    Statistical analysis title
    		 Difference in Feeling calm & safe during abortion
    Comparison groups
    Gestational age 64-70 days v Gestational age up to 63 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.233
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Provided with sufficient information before the abortion

    		 Close Top of page
    End point title
    		 Provided with sufficient information before the abortion
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    78
    106
        Neutral
    5
    9
        Not agreeing with the statement
    1
    5
    No statistical analyses for this end point

    Secondary: Provided with sufficient information before the abortion - Total score

    		 Close Top of page
    End point title
    		 Provided with sufficient information before the abortion - Total score
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Total score
        arithmetic mean (standard deviation)
    4.62 ± 0.66
    4.48 ± 0.9
    Statistical analysis title
    		 Difference in Provided with sufficient information
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.473
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Treatment matching patient`s expectations

    		 Close Top of page
    End point title
    		 Treatment matching patient`s expectations
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    68
    90
        Neutral
    10
    14
        Not agreeing with the statement
    5
    15
    No statistical analyses for this end point

    Secondary: Treatment matching patient`s expectations - Total score

    		 Close Top of page
    End point title
    		 Treatment matching patient`s expectations - Total score
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Total score
        arithmetic mean (standard deviation)
    4.19 ± 0.99
    3.95 ± 1.14
    Statistical analysis title
    		 Difference in Treatment matching expectations
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.136
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Experienced bleeding matching patient`s expectations

    		 Close Top of page
    End point title
    		 Experienced bleeding matching patient`s expectations
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    31
    60
        Neutral
    33
    39
        Not agreeing with the statement
    20
    21
    No statistical analyses for this end point

    Secondary: Experienced bleeding matching patient`s expectations - Total score

    		 Close Top of page
    End point title
    		 Experienced bleeding matching patient`s expectations - Total score
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Total score
        arithmetic mean (standard deviation)
    3.19 ± 1.25
    3.48 ± 1.11
    Statistical analysis title
    		 Difference in bleeding matching expactation
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Experienced pain matching patient`s expectations

    		 Close Top of page
    End point title
    		 Experienced pain matching patient`s expectations
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    31
    66
        Neutral
    24
    29
        Not agreeing with the statement
    30
    25
    No statistical analyses for this end point

    Secondary: Experienced pain matching patient`s expectations - Total score

    		 Close Top of page
    End point title
    		 Experienced pain matching patient`s expectations - Total score
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Total score
        arithmetic mean (standard deviation)
    2.98 ± 1.35
    3.52 ± 1.15
    Statistical analysis title
    		 Difference in experienced pain matching expectatio
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Provided with sufficient pain medication

    		 Close Top of page
    End point title
    		 Provided with sufficient pain medication
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    74
    102
        Neutral
    7
    11
        Not agreeing with the statement
    2
    7
    No statistical analyses for this end point

    Secondary: Provided with sufficient pain medication - Total score

    		 Close Top of page
    End point title
    		 Provided with sufficient pain medication - Total score
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Total score
        arithmetic mean (standard deviation)
    4.55 ± 0.84
    4.47 ± 1
    Statistical analysis title
    		 Difference in sufficient pain medication
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.805
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Recommendation of home abortion to a friend in the same situation

    		 Close Top of page
    End point title
    		 Recommendation of home abortion to a friend in the same situation
    End point description
    End point type
    Secondary
    End point timeframe
    14-28 days after the first appointment.
    End point values
    		 Gestational age up to 63 days Gestational age 64-70 days
    Number of subjects analysed
    84
    118
    Units: Number of women
        Agreeing with the statement
    76
    109
        Not agreeing with the statement
    4
    9
    Statistical analysis title
    		 Difference in recommend home abortion to a friend
    Comparison groups
    Gestational age up to 63 days v Gestational age 64-70 days
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.467
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study period, up to 14-28 days after the first appointment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Did not use any
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Overall group
    Reporting group description
    		 -

    Serious adverse events
    		 Overall group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 273 (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%
    Non-serious adverse events
    		 Overall group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 273 (0.00%)
    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: The study has no SAEs or AEs. For example, incomplete abortion is the primary outcome and cannot be classified as AE. Nausea, vomiting is related to pregnancy and bleeding is included in the abortion.

    More information

    		 Close Top of page

    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.
    Limitation is the sample size, making it difficult to state that home abortion 64-70 days is as safe as >63 days. But available data on home abortion, our results strengthen the assumption that the efficacy is high also in pregnancies >63 days.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Apr 28 00:15:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA