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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction.

    Summary
    EudraCT number
    		 2019-000620-17
    Trial protocol
    		 SE   FI  
    Global end of trial date
    31 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Sep 2024
    First version publication date
    20 Sep 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PPL17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04000438
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dilafor AB
    Sponsor organisation address
    Fogdevreten 2A, Solna, Sweden, SE-171 65
    Public contact
    Gunvor Ekman-Ordeberg, Chief Medical Officer, Dilafor AB, 46 706083111, Gunvor.ekman-ordeberg@dilafor.com
    Scientific contact
    Gunvor Ekman-Ordeberg, Chief Medical Officer, Dilafor AB, 46 706083111, Gunvor.ekman-ordeberg@dilafor.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
    29 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the Efficacy of tafoxiparin on cervical ripening
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki (Ethical principles for Medical Research Involving Human Subjects, revised by the World Medical Association’s (WMA) General Assembly, Fortaleza, Brazil, October 2013), 21 CFR - Part 50 (Protection of human subjects), 21 CFR – Part 54 (Financial Disclosure by Clinical Investigator) and 21 CFR – Part 312 (Investigational New Drug), and are consistent with the International Conference of Harmonization of Good Clinical Practice (ICH-GCP) (E6-R2, Step 4) guidelines. Informed consent was obtained from all healthy volunteers prior to initiation of the study. All subjects participating in the study were thoroughly informed about the study during Screening, given the opportunity to ask study-related questions to the Investigator and given sufficient time to review the patient information sheet. Following this procedure, all subjects wishing to participate in the study were asked to sign and date the ICF. The Investigator did also sign and date the ICF to confirm that the subject has been thoroughly informed about the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 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: 127
    Country: Number of subjects enrolled
    Finland: 238
    Worldwide total number of subjects
    365
    EEA total number of subjects
    365
    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)
    365
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 As the participating clinics will consist of maternity wards, potential subjects will present to the clinic as a part of standard clinical practice. All women must be examined to check the cervical state before information. After having had time to review the nature of the study, they will have the opportunity to ask questions.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 365
    Number of subjects completed
    		 348

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not pass inclusion/exclusion: 17
    Period 1
    Period 1 title
    Overall trial - Part A & B (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 - IMP 300 mg
    Arm description
    		 IMP tafoxiparin 300 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 1ml each from two vials injected as separate SC injections in the abdominal or hip region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tafoxiparin
    Investigational medicinal product code
    PPL17
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP tafoxiparin 300 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 1ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Arm title
    		 Cohort 2 - Placebo
    Arm description
    		 Placebo: 9 mg/ml of NaCl solution. 1.0 ml each from two vials injected as separate SC injections in the abdominal or hip region. The placebo saline solution was indistinguishable from the active solutions in appearance, smell and packaging.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo: 9 mg/ml of NaCl solution. 1.0 ml each from two vials injected as separate SC injections in the abdominal or hip region. The placebo saline solution was indistinguishable from the active solutions in appearance, smell and packaging.

    Arm title
    		 Cohort 3 - IMP 150 mg
    Arm description
    		 IMP tafoxiparin 150 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 0.5ml each from two vials injected as separate SC injections in the abdominal or hip region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tafoxiparin
    Investigational medicinal product code
    PPL17
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP tafoxiparin 150 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 0.5ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Arm title
    		 Cohort 4 - IMP 75 mg
    Arm description
    		 IMP tafoxiparin 75 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer and placebo solution 9 mg/ml of sodium chloride (NaCl) solution. 0.5ml each from one vial containing 150 mg/ml of tafoxiparin and one vial containing placebo, injected as separate SC injections in the abdominal or hip region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tafoxiparin
    Investigational medicinal product code
    PPL17
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP tafoxiparin 75 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer and placebo solution 9 mg/ml of sodium chloride (NaCl) solution. 0.5ml each from one vial containing 150 mg/ml of tafoxiparin and one vial containing placebo, injected as separate SC injections in the abdominal or hip region.

    Number of subjects in period 1 [1]
    		Cohort 1 - IMP 300 mg Cohort 2 - Placebo Cohort 3 - IMP 150 mg Cohort 4 - IMP 75 mg
    Started
    91
    89
    85
    83
    Completed
    90
    86
    85
    82
    Not completed
    1
    3
    0
    1
         Consent withdrawn by subject
    -
    2
    -
    -
         Reluctance to continue with the study drug
    -
    1
    -
    -
         None stated
    -
    -
    -
    1
         Hyponatremia, gestational hyperlipidemia
    1
    -
    -
    -
    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 per protocol the sponsor had the option to replace subjects who were withdrawn fron study prior receiving IMP. See study report section 9.3.3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 - IMP 300 mg
    Reporting group description
    		 IMP tafoxiparin 300 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 1ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Reporting group title
    Cohort 2 - Placebo
    Reporting group description
    		 Placebo: 9 mg/ml of NaCl solution. 1.0 ml each from two vials injected as separate SC injections in the abdominal or hip region. The placebo saline solution was indistinguishable from the active solutions in appearance, smell and packaging.

    Reporting group title
    Cohort 3 - IMP 150 mg
    Reporting group description
    		 IMP tafoxiparin 150 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 0.5ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Reporting group title
    Cohort 4 - IMP 75 mg
    Reporting group description
    		 IMP tafoxiparin 75 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer and placebo solution 9 mg/ml of sodium chloride (NaCl) solution. 0.5ml each from one vial containing 150 mg/ml of tafoxiparin and one vial containing placebo, injected as separate SC injections in the abdominal or hip region.

    Reporting group values
    		 Cohort 1 - IMP 300 mg Cohort 2 - Placebo Cohort 3 - IMP 150 mg Cohort 4 - IMP 75 mg Total
    Number of subjects
    		 91 89 85 83 348
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 91 89 85 83 348
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.2 ( 4.34 ) 31.3 ( 5.07 ) 31.4 ( 4.22 ) 31.6 ( 5.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 91 89 85 83 348
        Male
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 - IMP 300 mg
    Reporting group description
    		 IMP tafoxiparin 300 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 1ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Reporting group title
    Cohort 2 - Placebo
    Reporting group description
    		 Placebo: 9 mg/ml of NaCl solution. 1.0 ml each from two vials injected as separate SC injections in the abdominal or hip region. The placebo saline solution was indistinguishable from the active solutions in appearance, smell and packaging.

    Reporting group title
    Cohort 3 - IMP 150 mg
    Reporting group description
    		 IMP tafoxiparin 150 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 0.5ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Reporting group title
    Cohort 4 - IMP 75 mg
    Reporting group description
    		 IMP tafoxiparin 75 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer and placebo solution 9 mg/ml of sodium chloride (NaCl) solution. 0.5ml each from one vial containing 150 mg/ml of tafoxiparin and one vial containing placebo, injected as separate SC injections in the abdominal or hip region.

    Primary: Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Intercept

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    End point title
    		 Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Intercept
    End point description
    End point type
    Primary
    End point timeframe
    Up to 7 days.
    End point values
    		 Cohort 1 - IMP 300 mg Cohort 2 - Placebo Cohort 3 - IMP 150 mg Cohort 4 - IMP 75 mg
    Number of subjects analysed
    91
    88
    85
    83
    Units: Bishop Score
        arithmetic mean (standard deviation)
    2.61 ( 0.299 )
    2.42 ( 0.305 )
    2.34 ( 0.295 )
    2.14 ( 0.309 )
    Statistical analysis title
    		 Primary endpoint - Main statistical analyses
    Statistical analysis description
    Main statistical analyses used for the evaluation of primary and secondary efficacy endpoints, including Linear Mixed Model, ANCOVA, Logistic regression, Weibull models and Cox regression was performed with center and treatment included as covariates. Hence the evaluation of treatment effect was adjusted for center.
    Comparison groups
    Cohort 2 - Placebo v Cohort 1 - IMP 300 mg v Cohort 3 - IMP 150 mg v Cohort 4 - IMP 75 mg
    Number of subjects included in analysis
    347
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Primary: Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope

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    End point title
    		 Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope
    End point description
    End point type
    Primary
    End point timeframe
    up to 7 days.
    End point values
    		 Cohort 1 - IMP 300 mg Cohort 2 - Placebo Cohort 3 - IMP 150 mg Cohort 4 - IMP 75 mg
    Number of subjects analysed
    91
    89
    85
    83
    Units: Bishop Score
        arithmetic mean (standard deviation)
    0.86 ( 0.062 )
    0.62 ( 0.060 )
    0.81 ( 0.062 )
    0.78 ( 0.061 )
    Statistical analysis title
    		 Primary endpoint - Main statistical analyses
    Statistical analysis description
    Main statistical analyses used for the evaluation of primary and secondary efficacy endpoints, including Linear Mixed Model, ANCOVA, Logistic regression, Weibull models and Cox regression was performed with center and treatment included as covariates. Hence the evaluation of treatment effect was adjusted for center.
    Comparison groups
    Cohort 1 - IMP 300 mg v Cohort 2 - Placebo v Cohort 3 - IMP 150 mg v Cohort 4 - IMP 75 mg
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to until discharge from hospital.
    Adverse event reporting additional description
    During labor and post-partum, this definition is also applicable for the infant child.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Cohort 1 - IMP 300 mg
    Reporting group description
    		 IMP tafoxiparin 300 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 1ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Reporting group title
    Cohort 2 - Placebo
    Reporting group description
    		 Placebo: 9 mg/ml of NaCl solution. 1.0 ml each from two vials injected as separate SC injections in the abdominal or hip region. The placebo saline solution was indistinguishable from the active solutions in appearance, smell and packaging.

    Reporting group title
    Cohort 3 - IMP 150 mg
    Reporting group description
    		 IMP tafoxiparin 150 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer. 0.5ml each from two vials injected as separate SC injections in the abdominal or hip region.

    Reporting group title
    Cohort 4 - IMP 75 mg
    Reporting group description
    		 IMP tafoxiparin 75 mg: 150 mg/ml of tafoxiparin in 0.015 M phosphate buffer and placebo solution 9 mg/ml of sodium chloride (NaCl) solution. 0.5ml each from one vial containing 150 mg/ml of tafoxiparin and one vial containing placebo, injected as separate SC injections in the abdominal or hip region.

    Serious adverse events
    		 Cohort 1 - IMP 300 mg Cohort 2 - Placebo Cohort 3 - IMP 150 mg Cohort 4 - IMP 75 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 91 (6.59%)
    2 / 88 (2.27%)
    7 / 85 (8.24%)
    2 / 83 (2.41%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Total bile acids increased
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Procedural hemorrhage
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Postpartum haemorrhage
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bradycardia fetal
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Procedural headache
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Amniotic cavity infection
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum sepsis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 1 - IMP 300 mg Cohort 2 - Placebo Cohort 3 - IMP 150 mg Cohort 4 - IMP 75 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 91 (57.14%)
    47 / 88 (53.41%)
    54 / 85 (63.53%)
    54 / 83 (65.06%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Mesothelioma malignant
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 91 (3.30%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    3
    1
    0
    1
    Haemorrhage
         subjects affected / exposed
    2 / 91 (2.20%)
    3 / 88 (3.41%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematoma
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Vulval haematoma
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    Bladder catheterisation
         subjects affected / exposed
    6 / 91 (6.59%)
    3 / 88 (3.41%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    6
    3
    0
    0
    Caesarean section
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Episiotomy
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epidural anaesthesia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Perineal injury
         subjects affected / exposed
    2 / 91 (2.20%)
    4 / 88 (4.55%)
    17 / 85 (20.00%)
    21 / 83 (25.30%)
         occurrences all number
    2
    4
    17
    21
    Bradycardia foetal
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    6 / 85 (7.06%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    6
    3
    Tachycardia foetal
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    3 / 85 (3.53%)
    3 / 83 (3.61%)
         occurrences all number
    0
    0
    3
    3
    Postpartum haemorrhage
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    3 / 83 (3.61%)
         occurrences all number
    1
    0
    2
    3
    Gestational hypertension
         subjects affected / exposed
    1 / 91 (1.10%)
    3 / 88 (3.41%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    1
    3
    1
    1
    Uterine atony
         subjects affected / exposed
    3 / 91 (3.30%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Retained placenta or membranes
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    3 / 83 (3.61%)
         occurrences all number
    0
    1
    0
    3
    Oligohydramnios
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    2 / 83 (2.41%)
         occurrences all number
    0
    1
    1
    2
    Foetal distress syndrome
         subjects affected / exposed
    0 / 91 (0.00%)
    3 / 88 (3.41%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Labour pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    2
    1
    Inferior vena cava syndrome
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Symphysiolysis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Foetal hypokinesia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Transient tachypnoea of the newborn
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Prolonged labour
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Placental calcification
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pelvic haematoma obstetric
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Uterine hyperstimulation
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Uterine contractions abnormal
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    8 / 91 (8.79%)
    7 / 88 (7.95%)
    9 / 85 (10.59%)
    11 / 83 (13.25%)
         occurrences all number
    8
    7
    9
    11
    Injection site pain
         subjects affected / exposed
    8 / 91 (8.79%)
    1 / 88 (1.14%)
    2 / 85 (2.35%)
    0 / 83 (0.00%)
         occurrences all number
    14
    1
    2
    0
    Fatigue
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    4 / 85 (4.71%)
    5 / 83 (6.02%)
         occurrences all number
    1
    0
    4
    6
    Injection site pruritus
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    5
    0
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    3 / 85 (3.53%)
    1 / 83 (1.20%)
         occurrences all number
    1
    0
    3
    1
    Injection site discolouration
         subjects affected / exposed
    3 / 91 (3.30%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    3
    0
    1
    1
    Chills
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    2
    1
    2
    Injection site swelling
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    0 / 83 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 88 (1.14%)
    2 / 85 (2.35%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Feeling hot
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Injection site erythema
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Malaise
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Puncture site haemorrhage
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injection site warmth
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Vulvovaginal injury
         subjects affected / exposed
    2 / 91 (2.20%)
    5 / 88 (5.68%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    2
    5
    1
    1
    Cervical discharge
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    3
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    2 / 83 (2.41%)
         occurrences all number
    0
    1
    0
    3
    Endometriosis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    1
    0
    0
    1
    Vaginal haematoma
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Dyspnoea
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tachypnoea
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    6 / 91 (6.59%)
    3 / 88 (3.41%)
    2 / 85 (2.35%)
    4 / 83 (4.82%)
         occurrences all number
    6
    3
    3
    4
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Foetal monitoring abnormal
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Blood lactic acid increased
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 88 (2.27%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Blood lactate dehydrogenase abnormal
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Blood creatine increased
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Protein urine present
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Visual analogue scale
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Anal sphincter injury
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 88 (2.27%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Wound dehiscence
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Contusion
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anaesthetic complication
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Procedural haemorrhagee
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Obstetric procedure complication
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 91 (6.59%)
    5 / 88 (5.68%)
    7 / 85 (8.24%)
    8 / 83 (9.64%)
         occurrences all number
    6
    5
    7
    10
    Dizziness
         subjects affected / exposed
    1 / 91 (1.10%)
    3 / 88 (3.41%)
    0 / 85 (0.00%)
    2 / 83 (2.41%)
         occurrences all number
    1
    3
    0
    2
    Insomnia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    2 / 83 (2.41%)
         occurrences all number
    1
    0
    0
    2
    Tremor
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Post lumbar puncture syndrome
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Head discomfort
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Aura
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    6 / 85 (7.06%)
    3 / 83 (3.61%)
         occurrences all number
    1
    0
    6
    3
    Thrombocytopenia
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Thymus enlargement
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Tinnitus
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 91 (2.20%)
    6 / 88 (6.82%)
    6 / 85 (7.06%)
    2 / 83 (2.41%)
         occurrences all number
    3
    6
    7
    2
    Vomiting
         subjects affected / exposed
    2 / 91 (2.20%)
    3 / 88 (3.41%)
    6 / 85 (7.06%)
    5 / 83 (6.02%)
         occurrences all number
    2
    3
    6
    5
    Dyspepsia
         subjects affected / exposed
    2 / 91 (2.20%)
    4 / 88 (4.55%)
    0 / 85 (0.00%)
    3 / 83 (3.61%)
         occurrences all number
    2
    4
    0
    3
    Haemorrhoids
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    3 / 83 (3.61%)
         occurrences all number
    0
    0
    0
    3
    Abdominal pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    1
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 88 (2.27%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Skin discolouration
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin burning sensation
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    6 / 91 (6.59%)
    7 / 88 (7.95%)
    10 / 85 (11.76%)
    6 / 83 (7.23%)
         occurrences all number
    6
    8
    10
    6
    Dysuria
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Glycosuria
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oliguria
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Leukocyturia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    4 / 85 (4.71%)
    1 / 83 (1.20%)
         occurrences all number
    1
    0
    4
    1
    Neck pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bone pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Amniotic cavity infection
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    1 / 83 (1.20%)
         occurrences all number
    1
    1
    1
    1
    COVID-19
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    2 / 83 (2.41%)
         occurrences all number
    0
    0
    1
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    2 / 83 (2.41%)
         occurrences all number
    0
    0
    0
    2
    Infection
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Genital herpes simplex
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    0
    0
    1
    Streptococcal sepsis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 83 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2019
    Updates were made to Inclusion and Exclusion criteria as well as corresponding examinations performed during screening and baseline. Ripe cervix was defined as: “Bishop score ≥6”. Additional reasons for exceptions from reporting of SAEs during prolongation of hospitalization were updated.
    18 Dec 2020
    The following was added under section 7.2 Exclusion criteria “Any relevant condition, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study.” The following was added under section 7.4 Subject Withdrawal “Any subject who represents a protocol deviation may be replaced at the discretion of the Sponsor.”
    15 Jan 2021
    Updates were made to the Risk-Benefit Assessment section in the protocol to include more information on the ability of treatment with tafoxiparin inducing thrombocytopenia. Additionally, blood tests were added after the fifth dose of IMP and before discharge to detect cases of thrombocytopenia.
    01 Jul 2021
    The Risk Benefit assessment and Sample Size estimation was updated following completion of Part A of the study.
    15 Jan 2022
    The use of the term “Section” was changed to the term “Part” in order to avoid confusion with the protocol sections 1, 2, 3, 4, 5, 5.1, 5.2 etc. throughout the protocol. The change was administrative and effective throughout the protocol. Additionally, blood tests were added prior to labor induction and immediately prior to any epidural anesthesia, to detect cases of thrombocytopenia.

    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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