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  • Mylrea-Foley, BronachaImperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England.,Imperial College London (author)

Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise : the TRUFFLE 2 randomised trial protocol

  • Article/chapterEnglish2022

Publisher, publication year, extent ...

  • 2022-04-15
  • BMJ Publishing Group Ltd,2022
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-474011
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-474011URI
  • https://doi.org/10.1136/bmjopen-2021-055543DOI
  • https://lup.lub.lu.se/record/2dfe30f7-e48e-4e56-89c3-d75624d9b123URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:149362261URI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

Subject headings and genre

  • MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Reproduktionsmedicin och gynekologi hsv//swe
  • MEDICAL AND HEALTH SCIENCES Clinical Medicine Obstetrics, Gynaecology and Reproductive Medicine hsv//eng
  • fetal medicine
  • maternal medicine
  • ultrasonography
  • fetal medicine
  • maternal medicine
  • ultrasonography
  • abdominal circumference
  • Article
  • brain blood flow
  • cardiotocography
  • controlled study
  • Doppler flowmetry
  • female
  • fetus
  • fetus heart rate
  • fetus outcome
  • fetus weight
  • follow up
  • gestational age
  • human
  • hypoxia
  • middle cerebral artery
  • morbidity
  • nerve cell differentiation
  • newborn death
  • newborn morbidity
  • obstetric delivery
  • prematurity
  • pulsatility index
  • randomized controlled trial
  • umbilical artery
  • child
  • fetus echography
  • infant
  • intrauterine growth retardation
  • newborn
  • physiology
  • pregnancy
  • randomized controlled trial (topic)
  • Cardiotocography
  • Child
  • Female
  • Fetal Growth Retardation
  • Fetal Weight
  • Heart Rate, Fetal
  • Humans
  • Infant
  • Infant, Newborn
  • Pregnancy
  • Premature Birth
  • Randomized Controlled Trials as Topic
  • Ultrasonography, Prenatal

Added entries (persons, corporate bodies, meetings, titles ...)

  • Thornton, Jim G.Univ Nottingham, City Hosp, Dept Obstet & Gynaecol, Nottingham, England. (author)
  • Mullins, EdwardImperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England. (author)
  • Marlow, NeilUCL, Elizabeth Garrett Anderson Inst Womens Hlth, London, England. (author)
  • Hecher, KurtUniv Med Ctr Hamburg Eppendorf, Dept Obstet & Fetal Med, Hamburg, Germany. (author)
  • Ammari, ChristinaUniv Coll London Hosp NHS Fdn Trust, London, England. (author)
  • Arabin, BirgitHumboldt Univ, Dept Obstet Charite, Berlin, Germany. (author)
  • Berger, AstridUniv Hosp Innsbruck, Dept Obstet & Gynecol, Innsbruck, Austria. (author)
  • Bergman, Eva,1959-Uppsala universitet,Obstetrisk och reproduktiv hälsoforskning(Swepub:uu)evber534 (author)
  • Bhide, AmarnathSt Georges Univ Hosp NHS Fdn Trust, Fetal Med Unit, London, England. (author)
  • Bilardo, CaterinaVrije Univ Amsterdam, Dept Obstet Amsterdam, Noord Holland, Netherlands. (author)
  • Binder, JuliaMed Univ Vienna, Dept Obstet & Fetomaternal Med, Vienna, Austria. (author)
  • Breeze, AndrewLeeds Teaching Hosp NHS Trust, Fetal Med Unit, Leeds, W Yorkshire, England. (author)
  • Brodszki, JanaLund Skanes Univ Sjukhus Lund, Dept Obstet & Gynecol, Skane, Sweden. (author)
  • Calda, PavelCharles Univ Prague, Dept Obstet & Gynaecol, Prague, Czech Republic. (author)
  • Cannings-John, RebeccaMed Univ Vienna, Dept Obstet & Fetomaternal Med, Vienna, Austria. (author)
  • Cerny, AndrejCharles Univ Prague, Gen Univ Hosp, Dept Obstet & Gynaecol, Prague, Czech Republic.;Charles Univ Prague, Fac Med 1, Prague, Czech Republic. (author)
  • Cesari, ElenaCardiff Univ, Ctr Trials Res, Cardiff, Wales. (author)
  • Cetin, IreneCharles Univ Prague, Gen Univ Hosp, Dept Obstet & Gynaecol, Prague, Czech Republic.;Charles Univ Prague, Fac Med 1, Prague, Czech Republic. (author)
  • Dall'Asta, AndreaUniv Milan, Vittore Buzzi Hosp, Dept Obstet & Gynecol, Milan, Italy.;Univ Parma, Med & Surg, Parma, Italy. (author)
  • Diemert, AnkeUniv Med Ctr Hamburg Eppendorf, Dept Obstet & Fetal Med, Hamburg, Germany. (author)
  • Ebbing, CathrineSt Olavs Hosp, Trondheim, Norway. (author)
  • Eggebø, TorbjørnSt Olavs Hosp, Trondheim, Norway. (author)
  • Fantasia, IlariaRCCS Materno Infantile Burlo Garofolo, Unit Fetal Med & Prenatal Diag, Dipartimento Pediat, Trieste, Italy. (author)
  • Ferrazzi, EnricoRCCS Materno Infantile Burlo Garofolo, Unit Fetal Med & Prenatal Diag, Dipartimento Pediat, Trieste, Italy. (author)
  • Frusca, TizianaFdn IRCCS Ca Granda Osped Maggiore Policlin, Dept Clin Sci & Community Hlth, Milan, Italy. (author)
  • Ghi, TullioUniv Parma, Dept Obstet & Gynecol, Parma, Italy. (author)
  • Goodier, JennyUniv Parma, Dept Obstet & Gynecol, Parma, Italy. (author)
  • Greimel, PatrickMed Univ Graz, Dept Obstet & Gynecol, Graz, Austria. (author)
  • Gyselaers, WilfriedMed Univ Graz, Dept Obstet & Gynecol, Graz, Austria.;Hosp Oost Limburg, Dept Obstet & Gynecol, Genk, Belgium. (author)
  • Hassan, WassimEast Suffolk & North Essex NHS Fdn Trust, Colchester Hosp, Obstet & Gynaecol, Colchester, Essex, England. (author)
  • Von Kaisenberg, ConstantinHannover Med Sch, Obstet & Gynecol, Hannover, Germany. (author)
  • Kholin, AlexeyNatl Med Res Ctr Obstet Gynecol & Perinatol, Moscow, Russia. (author)
  • Klaritsch, PhilippEast Suffolk & North Essex NHS Fdn Trust, Colchester Hosp, Obstet & Gynaecol, Colchester, Essex, England. (author)
  • Krofta, LadislavHannover Med Sch, Obstet & Gynecol, Hannover, Germany. (author)
  • Lindgren, PeterKarolinska Institutet (author)
  • Lobmaier, SilviaKarolinska Inst, Dept Clin Sci Intervent & Technol CLINTEC, Div Obstet & Gynecol, Stockholm, Sweden. (author)
  • Marsal, KarelLund University,Lunds universitet,Obstetrik och gynekologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tornbladinstitutet,Forskargrupper vid Lunds universitet,Obstetrics and Gynaecology (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Tornblad Institute,Lund University Research Groups(Swepub:lu)gyn-kma (author)
  • Maruotti, Giuseppe M.Tech Univ Munich, Dept Obstet & Gynecol, Klinikum Rechts Isar, Munich, Germany. (author)
  • Mecacci, FedericoLund Univ, Fac Med, Obstet & Gynaecol, Lund, Sweden. (author)
  • Myklestad, KirstiFederico II Univ Hosp, Dept Neurosci Reprod & Dent Sci, Naples, Italy. (author)
  • Napolitano, RaffaeleUniv Hosp Careggi, High Risk Pregnancy Unit, Florence, Italy.;St Olavs Hosp Univ Hosp, Dept Obstet Childrens & Womens Hlth, Trondheim, Norway. (author)
  • Ostermayer, EvaTech Univ Munich, Dept Obstet & Gynecol, Klinikum Rechts Isar, Munich, Germany. (author)
  • Papageorghiou, ArisSt Georges Univ Hosp NHS Fdn Trust, Fetal Med Unit, London, England.;St Georges Univ London, Mol & Clin Sci Res Inst, London, England. (author)
  • Potter, ClaireSt Georges Univ London, Mol & Clin Sci Res Inst, London, England. (author)
  • Prefumo, FedericoUniv Brescia, Dept Obstet & Gynaecol, Brescia, Italy. (author)
  • Raio, LuigiUniv Bern, Dept Obstet & Gynaecol, Bern, Switzerland. (author)
  • Richter, JuteStavanger Univ Hosp, Dept Obstet & Gynaecol, Stavanger, Norway. (author)
  • Sande, Ragnar KvieKatholieke Univ Leuven, Dept Gynecol & Obstet, Leuven, Belgium. (author)
  • Schlembach, DietmarClin Obstet Med, Clinicum Neukoelln, Vivantes Network Hlth, Berlin, Germany. (author)
  • Schleussner, EkkehardUniv Klinikum Jena, Klin Geburtsmed, Jena, Germany. (author)
  • Stampalija, TamaraClin Obstet Med, Clinicum Neukoelln, Vivantes Network Hlth, Berlin, Germany.;Univ Klinikum Jena, Klin Geburtsmed, Jena, Germany. (author)
  • Thilaganathan, BaskySt Georges Univ Hosp NHS Fdn Trust, Fetal Med Unit, London, England.;St Georges Univ London, Mol & Clin Sci Res Inst, London, England. (author)
  • Townson, JuliaCharles Univ Prague, Dept Obstet & Gynaecol, Prague, Czech Republic. (author)
  • Valensise, HerbertPoliclin Casilino, Div Obstet & Gynaecol, Rome, Italy. (author)
  • Ha Visser, GerardUniv Utrecht, Univ Med Ctr, Dept Obstet, Utrecht, Netherlands. (author)
  • Wee, LingPrincess Alexandra Hosp NHS Trust, Obstet & Gynaecol, Harlow, Essex, England. (author)
  • Wolf, HansAmsterdam Univ Med Ctr, Dept Obstet & Gynaecol, Amsterdam, Netherlands. (author)
  • Lees, Christoph C.Imperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England.,Imperial College London (author)
  • Imperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England.Imperial College London (creator_code:org_t)
  • et al.

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  • In:BMJ Open: BMJ Publishing Group Ltd12:42044-6055

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