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:
    Immediate post partum LNG-IUS insertion or standard insertion procedure after childbirth An open-label, randomized, multicenter study

    Summary
    EudraCT number
    		 2017-001945-29
    Trial protocol
    		 SE  
    Global end of trial date
    21 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2022
    First version publication date
    29 Mar 2022
    Other versions
    Summary report(s)
    		 Published article

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    20170504
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Linköping University
    Sponsor organisation address
    University hospital, Linköping, Sweden, 58185
    Public contact
    Jan brynhildsen, Linköping University, 46 101030000, jan.brynhildsen@liu.se
    Scientific contact
    Jan brynhildsen, Linköping University, 46 101030000, jan.brynhildsen@liu.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
    Interim
    Date of interim/final analysis
    31 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to study if immediate insertion of LNG-IUS post-partum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to unintended pregnancies measured as number of abortions.
    Protection of trial subjects
    Possibility to directly contact study midwife (specific phone number) in case of questions or problems Planned interim analysis after 100 requite patients to evaluate the rates of IUD expulsion and risk of unintended pregnancy Contraceptive counseling for all women who ended participation
    Background therapy
    		 Not relevant
    Evidence for comparator
    		 No comparator. The study intended to compare different time points for LNG-IUS insertion post partum
    Actual start date of recruitment
    01 Jan 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: 102
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    102
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 All pregnant women attending maternal health care at 4 centers will receive information of the study. The nurse-midwife will visit the delivery wards and once again inform the now delivered women of the study. Women who opt for a LNG-IUD for contraception post-partum and will give informed consent will then be randomized according to the protocol

    Pre-assignment
    Screening details
    		 All pregnant women attending maternal health care at 4 centers will receive information of the study,). Each morning the study nurse-midwife will visit the delivery wards and once again inform the now delivered women of the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Immediate insertion
    Arm description
    		 Insertion of LNG-IUS with 48 hours post partum
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirena
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intrauterine delivery system
    Routes of administration
    Intrauterine use
    Dosage and administration details
    52mg

    Arm title
    		 Standard insertion
    Arm description
    		 Insertion of LNG-IUS 6-8 weeks post partum
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mirena
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intrauterine delivery system
    Routes of administration
    Intrauterine use
    Dosage and administration details
    52mg

    Number of subjects in period 1 [1]
    		Immediate insertion Standard insertion
    Started
    52
    49
    Completed
    52
    49
    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: As far as I can see the number reports in the base line characteristic is also 101

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 101 101
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 101 101
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        adults
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 101 101
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Interim/final
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    According to the study protocol an interim analysis should be performed after 100 included patients. he study was stopped according to predefined criteria. Consequently the interim analysis=the final analysis

    Subject analysis sets values
    		 Interim/final
    Number of subjects
    101
    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)
    101
        From 65-84 years
    0
        85 years and over
    0
        adults
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    101
        Male
    0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Immediate insertion
    Reporting group description
    		 Insertion of LNG-IUS with 48 hours post partum

    Reporting group title
    Standard insertion
    Reporting group description
    		 Insertion of LNG-IUS 6-8 weeks post partum

    Subject analysis set title
    Interim/final
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    According to the study protocol an interim analysis should be performed after 100 included patients. he study was stopped according to predefined criteria. Consequently the interim analysis=the final analysis

    Primary: Proportions of abortions within one year after insertion of LNG-IUS.

    		 Close Top of page
    End point title
    		 Proportions of abortions within one year after insertion of LNG-IUS. [1]
    End point description
    The primary objective is to study if immediate insertion of LNG-IUS post-partum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to unintended pregnancies measured as proportion of women undergoing an abortion.
    End point type
    Primary
    End point timeframe
    12 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No pregnancy and consequently no abortion occurred in any arm.
    End point values
    		 Immediate insertion Standard insertion Interim/final
    Number of subjects analysed
    52
    49
    101
    Units: unintended pregnancies
    number (not applicable)
        pregnancy
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Immediate
    Reporting group description
    		 -

    Reporting group title
    Standard
    Reporting group description
    		 -

    Serious adverse events
    		 Immediate Standard
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Reproductive system and breast disorders
    Uterine perforation
    Additional description: Two perforations occurred in the immediate group. Both detected after more than one year (after completion of the study) and required laparoscopy. Both patients recovered completely.
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Immediate Standard
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 52 (44.23%)
    0 / 49 (0.00%)
    Reproductive system and breast disorders
    IUD expulsion
    Additional description: In the early group 23/52 (44.2%) of hormonal IUDs were expelled,. No expulsions were detected in the standard group Actually outcome and not AE
    alternative assessment type: Non-systematic
         subjects affected / exposed
    23 / 52 (44.23%)
    0 / 49 (0.00%)
         occurrences all number
    23
    0

    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.
    None reported
    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-Mon Apr 29 06:41:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA