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    Clinical Trial Results:
    CONDISOX: Continued versus discontinued oxytocin stimulation of labour in a double-blind randomised controlled trial

    Summary
    EudraCT number
    		 2015-002942-30
    Trial protocol
    		 DK   NL  
    Global end of trial date
    02 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2021
    First version publication date
    20 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    01012015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Obstetrics and Gynecology, Regional Hospital of Randers
    Sponsor organisation address
    Skovlyvej 15, Randers, Denmark,
    Public contact
    Regional Hospital of Randers, Department of Obstetrics and Gynecology, Regional Hospital of Randers, sidander@rm.dk
    Scientific contact
    Regional Hospital of Randers, Department of Obstetrics and Gynecology, Regional Hospital of Randers, sidander@rm.dk
    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
    22 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The proposed study will investigate the effect of Syntocinon® to induce labour. The hypothesis to be studied is that once labour is established and the active phase of labour has commenced, Syntocinon® can be discontinued and the labour process will continue. The primary outcome will be the rate of caesarean delivery. The main secondary outcomes will be the duration of labour, neonatal conditions, maternal outcomes and satisfaction
    Protection of trial subjects
    Participants received standard care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    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
    Netherlands: 109
    Country: Number of subjects enrolled
    Denmark: 1091
    Worldwide total number of subjects
    1200
    EEA total number of subjects
    1200
    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)
    1200
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Women at 37–42 complete weeks of gestation stimulated with oxytocin infusion for induction of labour (with or without cervical priming by prostaglandin or cervical ripening catheter).

    Pre-assignment
    Screening details
    		 singleton pregnancy aged >18 years cephalic position of the baby

    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
    		 Investigator, Monitor, Data analyst, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Discontinued
    Arm description
    		 IN the active stage of labour oxytocin infusion will be replaced with intravenous infusion of 1 ml isotonic saline diluted in 1000 ml of isotonic saline (Denmark) or 1 ml isotonic saline diluted in 50 ml of isotonic saline (The Netherlands) and infusion will be continued until delivery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxytocin
    Investigational medicinal product code
    H 01 BB 02
    Other name
    Syntocinon
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    An intravenous infusion of 10 IU Syntocinon® diluted in 1000 ml of isotonic saline (Denmark) or 5 IU Syntocinon® diluted in 50 ml of isotonic saline (The Netherlands) was started at 3.3 mIU/minute and increased every 20 min by 3.3 mIU/minute until regular contractions (three to five contractions every 10min) were achieved. The maximal authorized infusion rate was 30 mIU/minute.

    Arm title
    		 Continued
    Arm description
    		 In the active stage of labour infusion will be replaced with intravenous infusion of 10 IU Syntocinon® diluted in 1000 ml of isotonic saline (Denmark) or 5 IU Syntocinon® diluted in 50 ml of isotonic saline (The Netherlands) and continued until delivery
    Arm type
    		 Routine

    Investigational medicinal product name
    Oxytocin
    Investigational medicinal product code
    H 01 BB 02
    Other name
    Syntocinon
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    An intravenous infusion of 10 IU Syntocinon® diluted in 1000 ml of isotonic saline (Denmark) or 5 IU Syntocinon® diluted in 50 ml of isotonic saline (The Netherlands) was started at 3.3 mIU/minute and increased every 20 min by 3.3 mIU/minute until regular contractions (three to five contractions every 10min) were achieved. The maximal authorized infusion rate was 30 mIU/minute.

    Number of subjects in period 1
    		Discontinued Continued
    Started
    607
    593
    Completed
    607
    591
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Discontinued
    Reporting group description
    		 IN the active stage of labour oxytocin infusion will be replaced with intravenous infusion of 1 ml isotonic saline diluted in 1000 ml of isotonic saline (Denmark) or 1 ml isotonic saline diluted in 50 ml of isotonic saline (The Netherlands) and infusion will be continued until delivery.

    Reporting group title
    Continued
    Reporting group description
    		 In the active stage of labour infusion will be replaced with intravenous infusion of 10 IU Syntocinon® diluted in 1000 ml of isotonic saline (Denmark) or 5 IU Syntocinon® diluted in 50 ml of isotonic saline (The Netherlands) and continued until delivery

    Reporting group values
    		 Discontinued Continued Total
    Number of subjects
    		 607 593 1200
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.0 ( 4.9 ) 31.3 ( 4.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 607 593 1200
        Male
    		 0 0 0
    White European
    Units: Subjects
        Yes
    		 531 510 1041
        No
    		 52 51 103
        Not recorded
    		 24 32 56
    Smoking during pregnancy
    Units: Subjects
        Yes
    		 96 79 175
        No
    		 496 502 998
        No reported
    		 15 12 27
    Married or living with a partner
    Units: Subjects
        Yes
    		 538 534 1072
        No
    		 59 52 111
        Not reported
    		 10 7 17
    Parity
    Units: Subjects
        Nulliparous
    		 404 398 802
        Parous with no previous Caesarean section
    		 147 155 302
        Parous with previous Caesarean section
    		 56 38 94
        Not reported
    		 0 2 2
    Indication for labour induction
    Units: Subjects
        Ruptured membranes
    		 230 221 451
        Diabetes
    		 43 39 82
        Postdate pregnancy
    		 102 120 222
        Hypertensive disorders
    		 66 71 137
        BMI>35
    		 24 18 42
        Oligehydramnios
    		 14 8 22
        Maternal request
    		 27 21 48
        Other
    		 101 95 196
    Cervical ripening
    Units: Subjects
        Prostaglandins
    		 253 237 490
        Cervical ripening catheter
    		 84 85 169
        Both
    		 39 40 79
        Not reported
    		 0 2 2
        None
    		 231 229 460
    Female sex of newborn
    Units: Subjects
        Yes
    		 283 275 558
        No
    		 324 316 640
        Not reported
    		 0 2 2
    Cervical dilatation at randomisation
    Units: Subjects
        <6
    		 15 7 22
        =6
    		 256 272 528
        =7
    		 108 118 226
        =8
    		 96 71 167
        =9
    		 52 33 85
        =10
    		 63 64 127
        Not reported
    		 17 28 45
    Pre-pregnancy BMI
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 25.2 (22.2 to 29.8) 24.8 (22.1 to 29.0) -
    Length. of gestation at birth
    Units: full weeks + days
        median (inter-quartile range (Q1-Q3))
    		 40.43 (39.14 to 41.29) 40.43 (39.14 to 41.43) -
    Birthweight
    Units: grams
        arithmetic mean (standard deviation)
    		 3646 ( 509 ) 3596 ( 502 ) -

    End points

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    End points reporting groups
    Reporting group title
    Discontinued
    Reporting group description
    		 IN the active stage of labour oxytocin infusion will be replaced with intravenous infusion of 1 ml isotonic saline diluted in 1000 ml of isotonic saline (Denmark) or 1 ml isotonic saline diluted in 50 ml of isotonic saline (The Netherlands) and infusion will be continued until delivery.

    Reporting group title
    Continued
    Reporting group description
    		 In the active stage of labour infusion will be replaced with intravenous infusion of 10 IU Syntocinon® diluted in 1000 ml of isotonic saline (Denmark) or 5 IU Syntocinon® diluted in 50 ml of isotonic saline (The Netherlands) and continued until delivery

    Primary: Mode of delivery

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    End point title
    		 Mode of delivery
    End point description
    End point type
    Primary
    End point timeframe
    At delivery
    End point values
    		 Discontinued Continued
    Number of subjects analysed
    607
    591
    Units: subjects
        Caesarean section
    101
    84
        Instrumental delivery
    64
    67
        Vaginal delivery
    442
    440
    Statistical analysis title
    		 Primary outcome - relative risk
    Comparison groups
    Discontinued v Continued
    Number of subjects included in analysis
    1198
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.53

    Secondary: Indication for Caesarean section

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    End point title
    		 Indication for Caesarean section
    End point description
    End point type
    Secondary
    End point timeframe
    at delivery
    End point values
    		 Discontinued Continued
    Number of subjects analysed
    101
    84
    Units: subjects
        Dystocia
    62
    58
        Suspicion of fetal asphyxia
    26
    13
        Suspicion of uterine rupture
    3
    1
        CHorioamnionitis
    2
    1
        Other
    8
    11
    No statistical analyses for this end point

    Secondary: Duration from start of initial oxytocin infusion to delivery

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    End point title
    		 Duration from start of initial oxytocin infusion to delivery
    End point description
    End point type
    Secondary
    End point timeframe
    At delivery
    End point values
    		 Discontinued Continued
    Number of subjects analysed
    607
    591
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    535 (314 to 797)
    477 (272 to 727)
    No statistical analyses for this end point

    Secondary: Duration from time of randomisation to delivery

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    End point title
    		 Duration from time of randomisation to delivery
    End point description
    End point type
    Secondary
    End point timeframe
    At delivery
    End point values
    		 Discontinued Continued
    Number of subjects analysed
    607
    591
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    282 (119 to 484)
    203 (77 to 397)
    No statistical analyses for this end point

    Secondary: Duration of second stage of labour

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    End point title
    		 Duration of second stage of labour
    End point description
    End point type
    Secondary
    End point timeframe
    At delivery
    End point values
    		 Discontinued Continued
    Number of subjects analysed
    607
    591
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    95 (31 to 198)
    78 (29 to 182)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until 7 days postpartum
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Summary of Products
    Dictionary version
    latest
    Reporting groups
    Reporting group title
    Continued
    Reporting group description
    		 Randomised to continuous stimulation

    Reporting group title
    discontinued
    Reporting group description
    		 Randomised to discontinued treatment

    Serious adverse events
    		 Continued discontinued
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 591 (0.00%)
    1 / 607 (0.16%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Perinatal death
         subjects affected / exposed
    0 / 591 (0.00%)
    1 / 607 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Continued discontinued
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    300 / 591 (50.76%)
    300 / 607 (49.42%)
    Pregnancy, puerperium and perinatal conditions
    Postpartumhaemorhage >500 mL
         subjects affected / exposed
    259 / 591 (43.82%)
    243 / 607 (40.03%)
         occurrences all number
    259
    243
    Retained products of conception
         subjects affected / exposed
    45 / 591 (7.61%)
    39 / 607 (6.43%)
         occurrences all number
    45
    39
    3rd and 4th degree perineal tear
         subjects affected / exposed
    27 / 591 (4.57%)
    25 / 607 (4.12%)
         occurrences all number
    27
    25
    Urineretention
         subjects affected / exposed
    20 / 591 (3.38%)
    25 / 607 (4.12%)
         occurrences all number
    20
    25
    Umbilical cord blood pH <7.1
         subjects affected / exposed
    40 / 591 (6.77%)
    42 / 607 (6.92%)
         occurrences all number
    40
    42
    Apgar score <7 at 5 minutes
         subjects affected / exposed
    6 / 591 (1.02%)
    4 / 607 (0.66%)
         occurrences all number
    6
    4

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30125998
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