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STV Analysis Versus Visual Evaluation of Cardiotocography in FGR (SAVEFGR)

Primary Purpose

Fetal Growth Retardation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short term variation
Visual interpretation
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Growth Retardation focused on measuring fetal growth restriction, cardiotocography, perinatal death, short term variation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring. Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (<p3) OR a combination of EFW <p10 AND uterine artery pulsatility index (PI) >p95 OR umbilical artery Doppler PI >p95. Maternal age ≥ 18 years. Able to provide written informed consent for collection and use of data on informed consent form in available language. Exclusion Criteria: Known congenital or chromosomal anomalies influencing perinatal outcome. Imminent labour or expected maternal indication for delivery < 48 hours.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Visual interpretation of cardiotocography

    Short term variation

    Arm Description

    Monitoring by visual interpretation of cardiotocography

    Short term variation by computer software analysis

    Outcomes

    Primary Outcome Measures

    Proportion of pregnancies resulting in perinatal death
    Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU

    Secondary Outcome Measures

    Proportion of children with major neonatal morbidity
    Major neonatal morbidity is a composite outcome defined as intraventricular hemorrhage grade 3 or more, periventricular leukomalacia grade 2 or more, moderate or severe bronchopulmonary dysplasia, necrotizing enterocolitis Bell stage 2 or more, or retinopathy of prematurity requiring therapy.
    Proportion of children with neonatal morbidities
    Individual neonatal morbidities of the abovementioned composite outcome and additionally persisting ductus arteriosus, persistent pulmonary hypertension of the newborn (PPHN), respiratory distress syndrome (RDS), period of invasive mechanical ventilation in days, medication need, hypoglycaemia, neonatal jaundice, sepsis and cardiovascular function.
    Proportion of children with neurodevelopmental impairment
    Neurodevelopmental impairment is defined as an abnormal test on Bayley III Dutch version (or version IV if available) (composite cognitive score < 85, composite motor score < 85), cerebral palsy, with a Gross Motor Function Classification System (GMFCS) grade > 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted) assessed at two years of corrected age

    Full Information

    First Posted
    July 21, 2023
    Last Updated
    August 17, 2023
    Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06010238
    Brief Title
    STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
    Acronym
    SAVEFGR
    Official Title
    Short Term Variation Analysis Versus Visual Evaluation of Cardiotocography in Fetal Growth Restriction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 1, 2027 (Anticipated)
    Study Completion Date
    January 1, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.
    Detailed Description
    Severe, early-onset fetal growth restriction (FGR, <32 weeks gestation) is a condition in which the fetus does not reach its growth potential due to placental insufficiency[. This condition affects about 0.3% of pregnancies, accounting for an estimated 15,000 babies in Europe being born premature below 32 weeks gestation. The main clinical dilemma of FGR lies in the timing of birth, given the balance of risks of antenatal mortality and severe damage to organs and the aggravated neonatal effects of prematurity: death or survival with severe neurodevelopmental impairment. The mainstay of clinical management in these cases pivots around the anticipation of the risk of fetal demise from placental oxygenation failure. The monitoring variables that are currently available comprise assessment of the severity of metabolic insufficiency (fetal size and growth, Doppler ultrasound, serum biomarkers) and the early detection of progressive fetal hypoxia with cardiotocography (CTG). The common approach is to deliver the fetus when signs of advanced hypoxia appear on CTG. A delicate balance exists between having the fetus born (too) early and facing the risks of extreme prematurity combined with a very low birthweight; and between delivering the fetus (too) late when the fetus has the disadvantage of hypoxia at birth. The decision when to deliver the fetus, is made mostly based on the CTG. The inter- and intra-observer variability could be overcome by software analysis according to the original Dawes&Redman algorithm. The software calculates the short-term variation (STV) of the inter-beat interval expressed in milliseconds, and a range of secondary calculations. In contrast with repeated decelerations, when fetal hypoxia is considered evident, the place of the software analysis of the fetal heart rate variability is less clear. Although the advantages of mathematized and uniform quantification of the fetal heart rate variability appear self-evident, there are no studies with sufficient power to detect an association of intervention based on STV at any threshold with the most important outcomes: fetal death and long-term infant outcome. The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in cCTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe, early-onset FGR.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fetal Growth Retardation
    Keywords
    fetal growth restriction, cardiotocography, perinatal death, short term variation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Stepped wedge cluster randomized clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Visual interpretation of cardiotocography
    Arm Type
    Active Comparator
    Arm Description
    Monitoring by visual interpretation of cardiotocography
    Arm Title
    Short term variation
    Arm Type
    Experimental
    Arm Description
    Short term variation by computer software analysis
    Intervention Type
    Device
    Intervention Name(s)
    Short term variation
    Intervention Description
    Short term variation in computer software analysis
    Intervention Type
    Device
    Intervention Name(s)
    Visual interpretation
    Intervention Description
    Visual interpretation of cardiotocography
    Primary Outcome Measure Information:
    Title
    Proportion of pregnancies resulting in perinatal death
    Description
    Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU
    Time Frame
    Before discharge from NICU, up to 1 year
    Secondary Outcome Measure Information:
    Title
    Proportion of children with major neonatal morbidity
    Description
    Major neonatal morbidity is a composite outcome defined as intraventricular hemorrhage grade 3 or more, periventricular leukomalacia grade 2 or more, moderate or severe bronchopulmonary dysplasia, necrotizing enterocolitis Bell stage 2 or more, or retinopathy of prematurity requiring therapy.
    Time Frame
    Before discharge from NICU, up to 1 year
    Title
    Proportion of children with neonatal morbidities
    Description
    Individual neonatal morbidities of the abovementioned composite outcome and additionally persisting ductus arteriosus, persistent pulmonary hypertension of the newborn (PPHN), respiratory distress syndrome (RDS), period of invasive mechanical ventilation in days, medication need, hypoglycaemia, neonatal jaundice, sepsis and cardiovascular function.
    Time Frame
    Before discharge from NICU, up to 1 year
    Title
    Proportion of children with neurodevelopmental impairment
    Description
    Neurodevelopmental impairment is defined as an abnormal test on Bayley III Dutch version (or version IV if available) (composite cognitive score < 85, composite motor score < 85), cerebral palsy, with a Gross Motor Function Classification System (GMFCS) grade > 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted) assessed at two years of corrected age
    Time Frame
    At two years of corrected age

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring. Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (<p3) OR a combination of EFW <p10 AND uterine artery pulsatility index (PI) >p95 OR umbilical artery Doppler PI >p95. Maternal age ≥ 18 years. Able to provide written informed consent for collection and use of data on informed consent form in available language. Exclusion Criteria: Known congenital or chromosomal anomalies influencing perinatal outcome. Imminent labour or expected maternal indication for delivery < 48 hours.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wessel Ganzevoort, MD PhD
    Phone
    003120-5669111
    Email
    j.w.ganzevoort@amsterdamumc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anouk Pels, MD PhD
    Phone
    003120-5669111
    Email
    a.pels@amsterdamumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wessel Ganzevoort, MD PhD
    Organizational Affiliation
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no current plan, but data will be available upon collaboration request

    Learn more about this trial

    STV Analysis Versus Visual Evaluation of Cardiotocography in FGR

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