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    Clinical Trial Results:
    Intrauterine resuscitation during term labor by maternal hyperoxygenation.

    Summary
    EudraCT number
    		 2015-001654-15
    Trial protocol
    		 NL  
    Global end of trial date
    12 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2022
    First version publication date
    09 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NL53018.015.15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Máxima Medisch Centrum
    Sponsor organisation address
    De Run 4600, Veldhoven, Netherlands, 5504 DB
    Public contact
    Principal investigator - Professor Guid Oei, Máxima Medisch Centrum, 0031 624225377, guidoei@outlook.com
    Scientific contact
    Principal investigator - Professor Guid Oei, Máxima Medisch Centrum, 0031 624225377, laurenbullens@gmail.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: the primary objective is to investigate the effect of maternal hyperoxygenation with 100% oxygen on fetal heart rate pattern. We will describe the difference in FHR deceleration depth, duration and frequency, baseline and variability 10 minutes before and after maternal oxygen administration.
    Protection of trial subjects
    The non-rebreathing mask used to deliver oxygen fits tight to the nose and mouth, which may cause some discomfort. Patients are allowed to withdraw from the study anytime.
    Background therapy
    		 Co-interventions may be initiated after 10 minutes of oxygen administration without a satisfactory effect on FHR. Co-interventions are ‘conventional care’, including lateral positioning of the parturient, stop oxytocin infusion, intermittent pushing, intravenous administration of a tocolytic drug or termination of labor by vaginal assisted delivery or caesarean section. In the control group 10 minutes after inclusion in the study ‘conventional care’ can be applied.
    Evidence for comparator
    		 The control group will receive conventional care (no additional oxygen). The only difference in treatment between the intervention and control group is the use of additional oxygen. Therefore, it is likely that any difference in outcome will be caused by the use of additional oxygen.
    Actual start date of recruitment
    01 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 117
    Worldwide total number of subjects
    117
    EEA total number of subjects
    117
    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)
    117
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient recruitment started on March 1st 2016, and was fulfilled on April 30th 2018. Recruitment took place in The Netherlands.

    Pre-assignment
    Screening details
    		 All patients eligible to be included in this study were asked to participate when they visited the outpatient’s clinic, or when they were admitted to the delivery ward. The total number of women eligible to be included in this study is not clear.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The patient and attending physician/midwife was not blinded to the allocation. Also the attending pediatrician providing Apgar score was not blinded.The investigator analyzing FHR patterns and fECG was blinded. Laboratory results are not influenced by the knowledge of the allocation and therefore laboratory staff did not need to be blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention group
    Arm description
    		 Maternal hyperoxygenation with 100% oxygen at 10 L/min delivered by a non-rebreathing mask (fraction of inspired oxygen 0.80)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxygen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    100% oxygen via non-rebreathing mask from the onset of fetal heart rate abnormalities, until delivery.

    Arm title
    		 Control group
    Arm description
    		 The control group will receive conventional care (no additional oxygen).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Intervention group Control group
    Started
    57
    60
    Completed
    57
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention group
    Reporting group description
    		 Maternal hyperoxygenation with 100% oxygen at 10 L/min delivered by a non-rebreathing mask (fraction of inspired oxygen 0.80)

    Reporting group title
    Control group
    Reporting group description
    		 The control group will receive conventional care (no additional oxygen).

    Reporting group values
    		 Intervention group Control group Total
    Number of subjects
    		 57 60 117
    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)
    		 57 60 117
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Maternal age
    Units: years
        median (standard deviation)
    		 31.8 ± 4.2 30.7 ± 3.4 -
    Gender categorical
    Female
    Units: Subjects
        Female
    		 27 34 61
        Male
    		 30 26 56
    Parity
    Primiparous versus multiparous women
    Units: Subjects
        primiparous women
    		 35 33 68
        multiparous women
    		 22 27 49
    Fetal sex
    Units: Subjects
        Male
    		 30 26 56
        Female
    		 27 34 61
    Gestational age
    Gestational age
    Units: days
        median (standard deviation)
    		 279 ± 9.0 280 ± 8.8 -
    Birthweight
    Units: gram(s)
        median (standard deviation)
    		 3510 ± 471.7 3541.4 ± 560.2 -
    Body mass index
    Maternal body mass index
    Units: kilogram(s)/cubic meter
        median (standard deviation)
    		 25 ± 4.7 24 ± 5.0 -

    End points

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    End points reporting groups
    Reporting group title
    Intervention group
    Reporting group description
    		 Maternal hyperoxygenation with 100% oxygen at 10 L/min delivered by a non-rebreathing mask (fraction of inspired oxygen 0.80)

    Reporting group title
    Control group
    Reporting group description
    		 The control group will receive conventional care (no additional oxygen).

    Primary: Change in fetal heart rate pattern before and after start of the study protocol

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    End point title
    		 Change in fetal heart rate pattern before and after start of the study protocol
    End point description
    End point type
    Primary
    End point timeframe
    10 minutes before the start of the study protocol compared to 5-15 minutes after the start of the study protocol.
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    36
    35
    Units: Improvement of FHR
        Deterioration FHR
    3
    12
        Equal FHR
    28
    22
        Improvement FHR
    5
    1
    Statistical analysis title
    		 Changes in FHR Odds radio
    Comparison groups
    Control group v Intervention group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 19.1

    Secondary: 1-minute Apgar score

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    End point title
    		 1-minute Apgar score
    End point description
    End point type
    Secondary
    End point timeframe
    1 minute after birth
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: number
        1 minute AS <5
    4
    4
        1 minute AS > 5
    53
    56
    Statistical analysis title
    		 1-minute Apgar score chi-square test
    Comparison groups
    Control group v Intervention group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: 5-minute Apgar score

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    End point title
    		 5-minute Apgar score
    End point description
    End point type
    Secondary
    End point timeframe
    5 minutes after birth
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: Number
        5-minute AS <7
    1
    3
        5-minute AS >7
    56
    57
    Statistical analysis title
    		 5-minute Apgar score Fisher's exact
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.62
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Median arterial umbilical cord pH

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    End point title
    		 Median arterial umbilical cord pH
    End point description
    End point type
    Secondary
    End point timeframe
    Generally umbilical cord pH is estimated <15 minutes after birth
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    45
    53
    Units: pH
        median (inter-quartile range (Q1-Q3))
    7.22 (7.19 to 7.26)
    7.20 (7.16 to 7.27)
    Statistical analysis title
    		 Medium arterial pH Mann-Whitney
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.35
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Median venous umbilical cord pH

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    End point title
    		 Median venous umbilical cord pH
    End point description
    End point type
    Secondary
    End point timeframe
    Generally umbilical cord pH is estimated < 15 minutes after birth
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: pH
        median (inter-quartile range (Q1-Q3))
    7.30 (7.26 to 7.34)
    7.30 (7.26 to 7.35)
    Statistical analysis title
    		 Median venous pH Mann-Whitney
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.94
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Arterial base excess

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    End point title
    		 Arterial base excess
    End point description
    End point type
    Secondary
    End point timeframe
    Umbilical cord blood values are generally estimated < 15 minutes after birth.
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    45
    51
    Units: mmol/l
        median (inter-quartile range (Q1-Q3))
    -6 (-8 to -3)
    -6 (-8 to -4)
    Statistical analysis title
    		 Arterial base excess Mann-Whitney
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.69
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Arterial pCO2 umbilical cord blood

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    End point title
    		 Arterial pCO2 umbilical cord blood
    End point description
    End point type
    Secondary
    End point timeframe
    Umbilical cord blood values are generally estimated < 15 minutes after birth.
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    45
    52
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    56 (51.5 to 59.5)
    57 (52 to 62)
    Statistical analysis title
    		 Arterial pCO2 Mann-Whitney
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.54
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Arterial malondialdehyde

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    End point title
    		 Arterial malondialdehyde
    End point description
    End point type
    Secondary
    End point timeframe
    Umbilical cord blood values are generally estimated < 15 minutes after birth.
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    41
    48
    Units: umol/l
        median (inter-quartile range (Q1-Q3))
    4.45 (3.68 to 5.35)
    4.15 (3.40 to 4.75)
    Statistical analysis title
    		 Arterial malondialdehyde Mann-Whitney
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.15
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Venous malondialdehyde

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    End point title
    		 Venous malondialdehyde
    End point description
    End point type
    Secondary
    End point timeframe
    Umbilical cord blood values are generally estimated < 15 minutes after birth.
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    45
    54
    Units: umol/l
        arithmetic mean (standard deviation)
    4.67 ± 1.27
    4.38 ± 1.15
    Statistical analysis title
    		 Venous malondialdehyde independent T-test
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.21
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: NICU admission

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    End point title
    		 NICU admission
    End point description
    Neonatal Intensive Care Unit admission
    End point type
    Secondary
    End point timeframe
    Directly after birth
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: number
    1
    2
    Statistical analysis title
    		 NICU admission s Fisher's exact
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Episiotomy for all indications

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    End point title
    		 Episiotomy for all indications
    End point description
    End point type
    Secondary
    End point timeframe
    Second stage of labor
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: number
    30
    33
    Statistical analysis title
    		 Episiotomy all indications Chi-squared
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Episiotomy for fetal indication

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    End point title
    		 Episiotomy for fetal indication
    End point description
    End point type
    Secondary
    End point timeframe
    Second stage of labor
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: number
    17
    27
    Statistical analysis title
    		 Episiotomy for fetal indication Chi-squared
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.09
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Assisted delivery for all indications

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    End point title
    		 Assisted delivery for all indications
    End point description
    End point type
    Secondary
    End point timeframe
    Second stage of labor
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: number
    7
    9
    Statistical analysis title
    		 Assisted delivery all indications Chi-squared
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.67
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Assisted delivery for fetal indication

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    End point title
    		 Assisted delivery for fetal indication
    End point description
    End point type
    Secondary
    End point timeframe
    Second stage of labor.
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: Number
    4
    6
    Statistical analysis title
    		 Assisted delivery fetal indication Fisher's exact
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.74
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Active second stage of labor

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    End point title
    		 Active second stage of labor
    End point description
    End point type
    Secondary
    End point timeframe
    Second stage of labor.
    End point values
    		 Intervention group Control group
    Number of subjects analysed
    57
    60
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    35 (20 to 64)
    25 (14 to 58)
    Statistical analysis title
    		 Active second stage of labor Mann-Whitney
    Comparison groups
    Intervention group v Control group
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.32
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 15 days after the sponsor has first knowledge of the serious adverse events. SAEs that result in death or are life threatening not later than 7 days after the responsible investigator has first knowledge of the adverse event.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ToetsingOnline
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 -

    Reporting group title
    Intervention group
    Reporting group description
    		 -

    Serious adverse events
    		 Control group Intervention group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 44 (2.27%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder neonatal
    Additional description: NICU-admissions
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control group Intervention group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 60 (50.00%)
    25 / 44 (56.82%)
    Surgical and medical procedures
    Caesarean section
    Additional description: Prolonged hospital stay due to secondary cesarean section
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    Cardiac disorders
    Hypertension
    Additional description: Hypertension or pre-eclampsia
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Pregnancy, puerperium and perinatal conditions
    Meconium stain
    Additional description: Prolonged observation neonate because of Apgar Score 4/7/9 and meconium-stained amniotic fluid
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Moaning neonatal
    Additional description: Observation neonate due to moaning after vacuum-assisted delivery
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Streptococcus test positive
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 44 (6.82%)
         occurrences all number
    1
    3
    Apgar score low
    Additional description: Prolonged observation neonate because of Apgar Score 1/6/8
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    SSRI use mother
    Additional description: Prolonged observation neonate due to birth >24h after rupture of membranes and due to use of medication mother (Selective serotonin reuptake inhibitors)
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    Premature baby
    Additional description: Prolonged observation neonate due to premature delivery with glucose checks neonate because of small for gestational age
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Small for dates baby
    Additional description: Prolonged observation neonate with glucose checks neonate because of small for gestational age.
         subjects affected / exposed
    3 / 60 (5.00%)
    6 / 44 (13.64%)
         occurrences all number
    3
    6
    Infection susceptibility increased
    Additional description: Prolonged observation neonate due to birth >24h after rupture of membranes of maternal fever during labor
         subjects affected / exposed
    12 / 60 (20.00%)
    6 / 44 (13.64%)
         occurrences all number
    12
    6
    Macrosomia
    Additional description: Prolonged observation neonate with glucose checks neonate because of large for gestational age.
         subjects affected / exposed
    8 / 60 (13.33%)
    8 / 44 (18.18%)
         occurrences all number
    8
    8
    Puerperal infection
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    Nervous system disorders
    Postspinal headache
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Post partum hemorrhage
    Additional description: Prolonged hospital stay because of postpartum hemorrhage of 2.4 liter due to vaginal tear and uterine atony. Hemoglobin postpartum 3.6 mmol/l for which the patient received 3 packed cells
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    neonatal anemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Bladder dysfunction
    Additional description: Prolonged hospital stay due to urine retention of the mother
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 44 (4.55%)
         occurrences all number
    2
    2
    Metabolism and nutrition disorders
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2015
    Inclusion criteria changed to including small for gestational age fetuses (estimated fetal weight < p10)
    15 Mar 2016
    Implementation of a modified method to monitor fECG.
    23 Mar 2017
    Asking patients enrolled in the study to fulfill a short questionnaire about how they feel about their labor.

    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.
    13 women in the intervention group did not receive oxygen administration for >5 minutes. 20 women were included while having exclusion criteria. Healthcare providers were not blinded for the allocation to the intervention or control group.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33345953
    http://www.ncbi.nlm.nih.gov/pubmed/33049730
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