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Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol
B. Mylrea-Foley, JG. Thornton, E. Mullins, N. Marlow, K. Hecher, C. Ammari, B. Arabin, A. Berger, E. Bergman, A. Bhide, C. Bilardo, J. Binder, A. Breeze, J. Brodszki, P. Calda, R. Cannings-John, A. Černý, E. Cesari, I. Cetin, A. Dall'Asta, A....
Jazyk angličtina Země Velká Británie
Typ dokumentu protokol klinické studie, časopisecké články, práce podpořená grantem
Grantová podpora
Department of Health - United Kingdom
NLK
Directory of Open Access Journals
od 2011
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od 2011
PubMed Central
od 2011
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od 2011
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od 2011-01-01
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od 2011-01-01
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od 2011-01-01
Nursing & Allied Health Database (ProQuest)
od 2011-01-01
Health & Medicine (ProQuest)
od 2011-01-01
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od 2011-01-01
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od 2011-01-01
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od 2011
- MeSH
- dítě MeSH
- hmotnost plodu MeSH
- kardiotokografie MeSH
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- předčasný porod * MeSH
- randomizované kontrolované studie jako téma MeSH
- růstová retardace plodu MeSH
- srdeční frekvence plodu fyziologie MeSH
- těhotenství MeSH
- ultrasonografie prenatální * MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH
INTRODUCTION: Following the detection of fetal growth restriction, there is no consensus about the criteria that should trigger delivery in the late preterm period. The consequences of inappropriate early or late delivery are potentially important yet practice varies widely around the world, with abnormal findings from fetal heart rate monitoring invariably leading to delivery. Indices derived from fetal cerebral Doppler examination may guide such decisions although there are few studies in this area. We propose a randomised, controlled trial to establish the optimum method of timing delivery between 32 weeks and 36 weeks 6 days of gestation. We hypothesise that delivery on evidence of cerebral blood flow redistribution reduces a composite of perinatal poor outcome, death and short-term hypoxia-related morbidity, with no worsening of neurodevelopmental outcome at 2 years. METHODS AND ANALYSIS: Women with non-anomalous singleton pregnancies 32+0 to 36+6 weeks of gestation in whom the estimated fetal weight or abdominal circumference is <10th percentile or has decreased by 50 percentiles since 18-32 weeks will be included for observational data collection. Participants will be randomised if cerebral blood flow redistribution is identified, based on umbilical to middle cerebral artery pulsatility index ratio values. Computerised cardiotocography (cCTG) must show normal fetal heart rate short term variation (≥4.5 msec) and absence of decelerations at randomisation. Randomisation will be 1:1 to immediate delivery or delayed delivery (based on cCTG abnormalities or other worsening fetal condition). The primary outcome is poor condition at birth and/or fetal or neonatal death and/or major neonatal morbidity, the secondary non-inferiority outcome is 2-year infant general health and neurodevelopmental outcome based on the Parent Report of Children's Abilities-Revised questionnaire. ETHICS AND DISSEMINATION: The Study Coordination Centre has obtained approval from London-Riverside Research Ethics Committee (REC) and Health Regulatory Authority (HRA). Publication will be in line with NIHR Open Access policy. TRIAL REGISTRATION NUMBER: Main sponsor: Imperial College London, Reference: 19QC5491. Funders: NIHR HTA, Reference: 127 976. Study coordination centre: Imperial College Healthcare NHS Trust, Du Cane Road, London, W12 0HS with Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University. IRAS Project ID: 266 400. REC reference: 20/LO/0031. ISRCTN registry: 76 016 200.
Centre for Trials Research Cardiff University Cardiff UK
Department of Gynecology and Obstetrics Katholieke Universiteit Leuven Leuven Belgium
Department of Obstetrics Amsterdam Vrije Universiteit Amsterdam Noord Holland Netherlands
Department of Obstetrics and Fetomaternal Medicine Medical University of Vienna Vienna Austria
Department of Obstetrics and Gynaecology Charles University Praha Czech Republic
Department of Obstetrics and Gynaecology Stavanger University Hospital Stavanger Norway
Department of Obstetrics and Gynaecology Università degli Studi di Brescia Brescia Italy
Department of Obstetrics and Gynaecology University of Bern Bern Switzerland
Department of Obstetrics and Gynaecology University of Nottingham City hospital Nottingham UK
Department of Obstetrics and Gynecology Hospital Oost Limburg Genk Belgium
Department of Obstetrics and Gynecology Lund Skanes universitetssjukhus Lund Skåne Sweden
Department of Obstetrics and Gynecology Medical University of Graz Graz Austria
Department of Obstetrics and Gynecology University Hospital of Innsbruck Innsbruck Austria
Department of Obstetrics and Gynecology University of Parma Parma Italy
Department of Obstetrics and Gynecology Vittore Buzzi Hospital University of Milan Milan Italy
Department of Obstetrics Charite Humboldt University of Berlin Berlin Germany
Department of Obstetrics University Medical Center Utrecht University Utrecht The Netherlands
Department of Women's and Children's Health Uppsala University Uppsala Sweden
Division of Obstetrics and Gynaecology Policlinico Casilino Roma Italy
Division of Obstetrics and Maternal Fetal Medicine Medical University of Graz Graz Austria
Elizabeth Garrett Anderson Institute for Women's Health University College London London UK
Fetal medicine Unit Leeds Teaching Hospitals NHS Trust Leeds UK
Fetal Medicine Unit St George's University Hospitals NHS Foundation Trust London UK
High Risk Pregnancy Unit University Hospital Careggi Firenze Italy
Institute for Care of Mother and Child Prague Czech Republic
Klinik für Geburtsmedizin Universitätsklinikum Jena Jena Germany
Medicine and Surgery University of Parma Parma Italy
Molecular and Clinical Sciences Research Institute St George's University of London London UK
National Medical Research Center for Obstetrics Gynecology and Perinatology Moscow Russia
Obstetrics and Gynaecology Faculty of Medicine Lunds Universitet Lund Sweden
Obstetrics And Gynaecology Princess Alexandra Hospital NHS Trust Harlow UK
Obstetrics and Gynecology Hannover Medical School Hannover Germany
St Olav's Hospital Trondheim Norway
University College London Hospitals NHS Foundation Trust London UK
Vivantes Network for Health Clinicum Neukoelln Clinic for Obstetric Medicine Berlin Germany
Citace poskytuje Crossref.org
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