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    Clinical Trial Results:
    Paracervical block (PCB) during II-trimester abortion – a randomized controlled trial

    Summary
    EudraCT number
    		 2010-020780-21
    Trial protocol
    		 SE  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2021
    First version publication date
    31 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    W2010IM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01617564
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    17177, Stockholm, Sweden,
    Public contact
    Kristina Gemzell Danielsson, Karolinska Institutet, kristina.gemzell@ki.se
    Scientific contact
    Kristina Gemzell Danielsson, Karolinska Institutet, 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
    30 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Can the number of women who experience severe pain (VAS> 7) during induced abortion after 13 weeks of gestation, be reduced through the use of PCBs with Marcain ® as a method of pain relief during abortion?
    Protection of trial subjects
    Participation was voluntary and written informed consent was obtained prior to participating in any study-related activity.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 May 2012
    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: 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

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    Recruitment
    Recruitment details
    		 Women were recruited from a gynaecological clinic in Sweden between during May 2012 until April 2015.

    Pre-assignment
    Screening details
    		 Women who were 18 years or older, gestational age from 13 weeks and being able to understand Swedish were screened for participation. 589 women had a second-trimester abortion during the time period, 276 of those women were informed and invited to participate in the study, and 113 women were recruited.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received a PCB (Paracervical block) with 20 ml sodium chloride 9 mg/ml (Placebo).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracervical use
    Dosage and administration details
    The PCB was administered as a 2–4 mm deep paracervical injection into the mucosa at two sites (2 and 8 o’clock), and was applied by using a Kobac’s needle or an ordinary injection needle (0.8 × 80 mm)during a speculum examination. The procedure lasted for 5 min. The PCB was applied 1 h after the first dose of misoprostol.

    Arm title
    		 Bupivacaine
    Arm description
    		 Participants received a PCB (Paracervical block) with 20 ml local anaesthesia (bupivacaine 2.5 mg/ml)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracervical use
    Dosage and administration details
    The PCB was administered as a 2–4 mm deep paracervical injection into the mucosa at two sites (2 and 8 o’clock), and was applied by using a Kobac’s needle or an ordinary injection needle (0.8 × 80 mm) during a speculum examination. The procedure lasted for 5 min. The PCB was applied 1 h after the first dose of misoprostol.

    Number of subjects in period 1
    		Placebo Bupivacaine
    Started
    50
    52
    Completed
    50
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a PCB (Paracervical block) with 20 ml sodium chloride 9 mg/ml (Placebo).

    Reporting group title
    Bupivacaine
    Reporting group description
    		 Participants received a PCB (Paracervical block) with 20 ml local anaesthesia (bupivacaine 2.5 mg/ml)

    Reporting group values
    		 Placebo Bupivacaine Total
    Number of subjects
    		 50 52 102
    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)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        <25
    		 15 22 37
        25-34
    		 19 20 39
        >=35
    		 16 10 26
    Gender categorical
    Units: Subjects
        Female
    		 50 52 102
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a PCB (Paracervical block) with 20 ml sodium chloride 9 mg/ml (Placebo).

    Reporting group title
    Bupivacaine
    Reporting group description
    		 Participants received a PCB (Paracervical block) with 20 ml local anaesthesia (bupivacaine 2.5 mg/ml)

    Primary: Highest pain intensity

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    End point title
    		 Highest pain intensity
    End point description
    Can paracervical block (PCB) administered before the onset of pain decrease women’s pain experience during secondtrimester medical termination of pregnancy (MToP)? Pain was measured by VAS (visual analogue scale) where VAS 7-10 = severe pain.
    End point type
    Primary
    End point timeframe
    Pain was measured at misoprostol initiation (baseline) and repeated every 30 min until fetal expulsion. The primary outcome was at any time point.
    End point values
    		 Placebo Bupivacaine
    Number of subjects analysed
    50
    52
    Units: VAS
        VAS 0-6
    17
    13
        VAS 7-10
    32
    39
    Statistical analysis title
    		 Difference in highest pain intensity VAS 7-10
    Comparison groups
    Placebo v Bupivacaine
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.292
    Method
    		 Generalized estimating equations model
    Parameter type
    		 Risk ratio (RR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Misoprostol initiation (baseline) and repeated every 30 min until fetal expulsion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a PCB (Paracervical block) with 20 ml sodium chloride 9 mg/ml (Placebo).

    Reporting group title
    Bupivacaine
    Reporting group description
    		 Participants received a PCB (Paracervical block) with 20 ml local anaesthesia (bupivacaine 2.5 mg/ml)

    Serious adverse events
    		 Placebo Bupivacaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Bupivacaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 50 (28.00%)
    14 / 52 (26.92%)
    Cardiac disorders
    Dizziness
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 52 (5.77%)
         occurrences all number
    50
    52
    General disorders and administration site conditions
    Sensory loss
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    50
    52
    Headache
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    50
    52
    Gastrointestinal disorders
    Nausea/vomiting
         subjects affected / exposed
    8 / 50 (16.00%)
    8 / 52 (15.38%)
         occurrences all number
    50
    52
    Respiratory, thoracic and mediastinal disorders
    Shortness of breath
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences all number
    50
    52
    Skin and subcutaneous tissue disorders
    Skin rush
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences all number
    50
    52
    Musculoskeletal and connective tissue disorders
    Shivering
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 52 (3.85%)
         occurrences all number
    50
    52

    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.
    Nearly 60% of the invited women did notwant to participate in the study (fear of needles and fear of receiving the placebo) therefore women who tolerate pain may have been overrepresented in the study population.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26573530
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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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