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    Clinical Trial Results:
    Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a pilot study

    Summary
    EudraCT number
    		 2013-001554-10
    Trial protocol
    		 NL  
    Global end of trial date
    31 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2022
    First version publication date
    09 Aug 2022
    Other versions
    Summary report(s)
    		 Pilot study article

    Trial information

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    Trial identification
    Sponsor protocol code
    NL57892
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein-Zuid 10, Nijmegen, Netherlands, 6525GA
    Public contact
    Afdeling Gynaecologie, Radboudumc, +31 0243614788, menm.trial@gmail.com
    Scientific contact
    Afdeling Gynaecologie, Radboudumc, +31 0243614788, menm.trial@gmail.com
    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 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will compare sequential mifepristone and misoprostol (“M&M”) treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands.
    Protection of trial subjects
    Ethics approval was obtained; CMO Arnhem-Nijmegen, file number 2015-2264, NL 57892.091.16.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2016
    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
    Netherlands: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A two-centred, prospective, two-armed, randomized, double blinded and placebo-controlled pilot trial was performed, situated in an academic (Radboud University Medical Centre) and a teaching hospital (Canisius-Wilhelmina Hospital) in Nijmegen, the Netherlands, between October 2016 and May 2017.

    Pre-assignment
    Screening details
    		 Woman with a diagnosis of EPF between 6 and 14 weeks of gestation were eligible, defined by transvaginal ultrasonography as an intra-uterine pregnancy and a crown-rump length ≥ 6 mm and no cardiac activity, or a gestational sac without embryonic pole confirmed by a second ultrasound at least one week later.

    Period 1
    Period 1 title
    Inclusion (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The blinding of patients and physicians for treatment arm was maintained until the follow-up (questionnaire four weeks after treatment) of the last included patient was completed

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 M&M group
    Arm description
    		 Mifepristone + misoprostol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    mifepristone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg oral once

    Arm title
    		 placebo
    Arm description
    		 placebo + misoprostol
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    placebo, once

    Number of subjects in period 1
    		M&M group placebo
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    M&M group
    Reporting group description
    		 Mifepristone + misoprostol

    Reporting group title
    placebo
    Reporting group description
    		 placebo + misoprostol

    Reporting group values
    		 M&M group placebo Total
    Number of subjects
    		 20 20 40
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 20 40
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 20 20 40
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    M&M
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Data were analysed according to intention to treat method. The main outcome variable was complete evacuation after medical treatment and was assessed by calculating success rates, relative risks and 95% confident intervals in both groups. To evaluate the potential of each of the strategies, we also performed a per protocol analysis, taking into account only those cases that were treated according to protocol. SPSS version 24 was used for data analysis. Differences between groups were analysed using the Pearson’s chi-square test or the Fisher’s exact test for categorical variables. Mann-Whitney U test was used for non-normally distributed metric variables. Logistic regression analysis was performed to identify factors that were associated with treatment success. P-values smaller than 0.05, were considered significant.

    Subject analysis sets values
    		 M&M
    Number of subjects
    39
    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)
    39
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    39
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    M&M group
    Reporting group description
    		 Mifepristone + misoprostol

    Reporting group title
    placebo
    Reporting group description
    		 placebo + misoprostol

    Subject analysis set title
    M&M
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Data were analysed according to intention to treat method. The main outcome variable was complete evacuation after medical treatment and was assessed by calculating success rates, relative risks and 95% confident intervals in both groups. To evaluate the potential of each of the strategies, we also performed a per protocol analysis, taking into account only those cases that were treated according to protocol. SPSS version 24 was used for data analysis. Differences between groups were analysed using the Pearson’s chi-square test or the Fisher’s exact test for categorical variables. Mann-Whitney U test was used for non-normally distributed metric variables. Logistic regression analysis was performed to identify factors that were associated with treatment success. P-values smaller than 0.05, were considered significant.

    Primary: Complete evacuation

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    End point title
    		 Complete evacuation
    End point description
    Primary and secondary outcome measures were extracted from the patient medical record, diary, digital questionnaires and/or case report form. The primary outcome parameter, complete (success) or incomplete (failure) evacuation, was determined by transvaginal ultrasonography one week (six to nine days) after medical treatment. Expulsion of the gestational sac and an endometrial thickness < 15 mm (maximum anterior-posterior diameter) using only the allocated therapy by randomization was considered as complete evacuation.[7, 9, 18-20] D&C performed because of heavy vaginal bleeding during medical treatment was also considered as failure.
    End point type
    Primary
    End point timeframe
    follow up untill 6 weeks after medical treatment
    End point values
    		 M&M group placebo
    Number of subjects analysed
    20
    19
    Units: ultrasonography / clinical assessment
        number (not applicable)
    20
    19
    Statistical analysis title
    		 complete evacuation
    Comparison groups
    placebo v M&M group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 weeks after medical treatment
    Adverse event reporting additional description
    adverse events were reported in either group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 test
    Dictionary version
    2
    Reporting groups
    Reporting group title
    both
    Reporting group description
    		 No serious adverse events were reported in either group. Quality of life was similar in both groups.

    Serious adverse events
    		 both
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 both
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 40 (7.50%)
    Surgical and medical procedures
    curettage
    Additional description: The need for D&C was significantly lower in the M&M group as compared to the placebo group: 2/19 (10,5%) versus 10/20 (50%) respectively (p 0.008, RR 1.789, 95% CI 1.124-2.848).
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    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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    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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