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

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

Mylrea-Foley, Bronacha (författare): Imperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England.,Imperial College London

Thornton, Jim G. (författare): Univ Nottingham, City Hosp, Dept Obstet & Gynaecol, Nottingham, England.

Mullins, Edward (författare): Imperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England.

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Marlow, Neil (författare): UCL, Elizabeth Garrett Anderson Inst Womens Hlth, London, England.

Hecher, Kurt (författare): Univ Med Ctr Hamburg Eppendorf, Dept Obstet & Fetal Med, Hamburg, Germany.

Ammari, Christina (författare): Univ Coll London Hosp NHS Fdn Trust, London, England.

Arabin, Birgit (författare): Humboldt Univ, Dept Obstet Charite, Berlin, Germany.

Berger, Astrid (författare): Univ Hosp Innsbruck, Dept Obstet & Gynecol, Innsbruck, Austria.

Bergman, Eva, 1959- (författare): Uppsala universitet,Obstetrisk och reproduktiv hälsoforskning

Bhide, Amarnath (författare): St Georges Univ Hosp NHS Fdn Trust, Fetal Med Unit, London, England.

Bilardo, Caterina (författare): Vrije Univ Amsterdam, Dept Obstet Amsterdam, Noord Holland, Netherlands.

Binder, Julia (författare): Med Univ Vienna, Dept Obstet & Fetomaternal Med, Vienna, Austria.

Breeze, Andrew (författare): Leeds Teaching Hosp NHS Trust, Fetal Med Unit, Leeds, W Yorkshire, England.

Brodszki, Jana (författare): Lund Skanes Univ Sjukhus Lund, Dept Obstet & Gynecol, Skane, Sweden.

Calda, Pavel (författare): Charles Univ Prague, Dept Obstet & Gynaecol, Prague, Czech Republic.

Cannings-John, Rebecca (författare): Med Univ Vienna, Dept Obstet & Fetomaternal Med, Vienna, Austria.

Cerny, Andrej (författare): Charles Univ Prague, Gen Univ Hosp, Dept Obstet & Gynaecol, Prague, Czech Republic.;Charles Univ Prague, Fac Med 1, Prague, Czech Republic.

Cesari, Elena (författare): Cardiff Univ, Ctr Trials Res, Cardiff, Wales.

Cetin, Irene (författare): Charles Univ Prague, Gen Univ Hosp, Dept Obstet & Gynaecol, Prague, Czech Republic.;Charles Univ Prague, Fac Med 1, Prague, Czech Republic.

Dall'Asta, Andrea (författare): Univ Milan, Vittore Buzzi Hosp, Dept Obstet & Gynecol, Milan, Italy.;Univ Parma, Med & Surg, Parma, Italy.

Diemert, Anke (författare): Univ Med Ctr Hamburg Eppendorf, Dept Obstet & Fetal Med, Hamburg, Germany.

Ebbing, Cathrine (författare): St Olavs Hosp, Trondheim, Norway.

Eggebø, Torbjørn (författare): St Olavs Hosp, Trondheim, Norway.

Fantasia, Ilaria (författare): RCCS Materno Infantile Burlo Garofolo, Unit Fetal Med & Prenatal Diag, Dipartimento Pediat, Trieste, Italy.

Ferrazzi, Enrico (författare): RCCS Materno Infantile Burlo Garofolo, Unit Fetal Med & Prenatal Diag, Dipartimento Pediat, Trieste, Italy.

Frusca, Tiziana (författare): Fdn IRCCS Ca Granda Osped Maggiore Policlin, Dept Clin Sci & Community Hlth, Milan, Italy.

Ghi, Tullio (författare): Univ Parma, Dept Obstet & Gynecol, Parma, Italy.

Goodier, Jenny (författare): Univ Parma, Dept Obstet & Gynecol, Parma, Italy.

Greimel, Patrick (författare): Med Univ Graz, Dept Obstet & Gynecol, Graz, Austria.

Gyselaers, Wilfried (författare): Med Univ Graz, Dept Obstet & Gynecol, Graz, Austria.;Hosp Oost Limburg, Dept Obstet & Gynecol, Genk, Belgium.

Hassan, Wassim (författare): East Suffolk & North Essex NHS Fdn Trust, Colchester Hosp, Obstet & Gynaecol, Colchester, Essex, England.

Von Kaisenberg, Constantin (författare): Hannover Med Sch, Obstet & Gynecol, Hannover, Germany.

Kholin, Alexey (författare): Natl Med Res Ctr Obstet Gynecol & Perinatol, Moscow, Russia.

Klaritsch, Philipp (författare): East Suffolk & North Essex NHS Fdn Trust, Colchester Hosp, Obstet & Gynaecol, Colchester, Essex, England.

Krofta, Ladislav (författare): Hannover Med Sch, Obstet & Gynecol, Hannover, Germany.

Lindgren, Peter (författare): Karolinska Institutet

Lobmaier, Silvia (författare): Karolinska Inst, Dept Clin Sci Intervent & Technol CLINTEC, Div Obstet & Gynecol, Stockholm, Sweden.

Marsal, Karel (författare): Lund 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

Maruotti, Giuseppe M. (författare): Tech Univ Munich, Dept Obstet & Gynecol, Klinikum Rechts Isar, Munich, Germany.

Mecacci, Federico (författare): Lund Univ, Fac Med, Obstet & Gynaecol, Lund, Sweden.

Myklestad, Kirsti (författare): Federico II Univ Hosp, Dept Neurosci Reprod & Dent Sci, Naples, Italy.

Napolitano, Raffaele (författare): Univ Hosp Careggi, High Risk Pregnancy Unit, Florence, Italy.;St Olavs Hosp Univ Hosp, Dept Obstet Childrens & Womens Hlth, Trondheim, Norway.

Ostermayer, Eva (författare): Tech Univ Munich, Dept Obstet & Gynecol, Klinikum Rechts Isar, Munich, Germany.

Papageorghiou, Aris (författare): St Georges Univ Hosp NHS Fdn Trust, Fetal Med Unit, London, England.;St Georges Univ London, Mol & Clin Sci Res Inst, London, England.

Potter, Claire (författare): St Georges Univ London, Mol & Clin Sci Res Inst, London, England.

Prefumo, Federico (författare): Univ Brescia, Dept Obstet & Gynaecol, Brescia, Italy.

Raio, Luigi (författare): Univ Bern, Dept Obstet & Gynaecol, Bern, Switzerland.

Richter, Jute (författare): Stavanger Univ Hosp, Dept Obstet & Gynaecol, Stavanger, Norway.

Sande, Ragnar Kvie (författare): Katholieke Univ Leuven, Dept Gynecol & Obstet, Leuven, Belgium.

Schlembach, Dietmar (författare): Clin Obstet Med, Clinicum Neukoelln, Vivantes Network Hlth, Berlin, Germany.

Schleussner, Ekkehard (författare): Univ Klinikum Jena, Klin Geburtsmed, Jena, Germany.

Stampalija, Tamara (författare): Clin Obstet Med, Clinicum Neukoelln, Vivantes Network Hlth, Berlin, Germany.;Univ Klinikum Jena, Klin Geburtsmed, Jena, Germany.

Thilaganathan, Basky (författare): St Georges Univ Hosp NHS Fdn Trust, Fetal Med Unit, London, England.;St Georges Univ London, Mol & Clin Sci Res Inst, London, England.

Townson, Julia (författare): Charles Univ Prague, Dept Obstet & Gynaecol, Prague, Czech Republic.

Valensise, Herbert (författare): Policlin Casilino, Div Obstet & Gynaecol, Rome, Italy.

Ha Visser, Gerard (författare): Univ Utrecht, Univ Med Ctr, Dept Obstet, Utrecht, Netherlands.

Wee, Ling (författare): Princess Alexandra Hosp NHS Trust, Obstet & Gynaecol, Harlow, Essex, England.

Wolf, Hans (författare): Amsterdam Univ Med Ctr, Dept Obstet & Gynaecol, Amsterdam, Netherlands.

Lees, Christoph C. (författare): Imperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England.,Imperial College London

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Imperial Coll London, Queen Charlottes & Chelsea Hosp London, Obstet & Gynaecol, London, England Imperial College London (creator_code:org_t)

et al

2022-04-15
2022
Engelska.
Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 12:4

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://uu.diva-port... (primary) (Raw object); http://dx.doi.org/10... (free); https://urn.kb.se/re...; https://doi.org/10.1...; https://lup.lub.lu.s...; http://kipublication...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)

Nyckelord

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

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Av författaren/redakt...: Mylrea-Foley, Br ...; Thornton, Jim G.; Mullins, Edward; Marlow, Neil; Hecher, Kurt; Ammari, Christin ...; visa fler...; Arabin, Birgit; Berger, Astrid; Bergman, Eva, 19 ...; Bhide, Amarnath; Bilardo, Caterin ...; Binder, Julia; Breeze, Andrew; Brodszki, Jana; Calda, Pavel; Cannings-John, R ...; Cerny, Andrej; Cesari, Elena; Cetin, Irene; Dall'Asta, Andre ...; Diemert, Anke; Ebbing, Cathrine; Eggebø, Torbjørn; Fantasia, Ilaria; Ferrazzi, Enrico; Frusca, Tiziana; Ghi, Tullio; Goodier, Jenny; Greimel, Patrick; Gyselaers, Wilfr ...; Hassan, Wassim; Von Kaisenberg, ...; Kholin, Alexey; Klaritsch, Phili ...; Krofta, Ladislav; Lindgren, Peter; Lobmaier, Silvia; Marsal, Karel; Maruotti, Giusep ...; Mecacci, Federic ...; Myklestad, Kirst ...; Napolitano, Raff ...; Ostermayer, Eva; Papageorghiou, A ...; Potter, Claire; Prefumo, Federic ...; Raio, Luigi; Richter, Jute; Sande, Ragnar Kv ...; Schlembach, Diet ...; Schleussner, Ekk ...; Stampalija, Tama ...; Thilaganathan, B ...; Townson, Julia; Valensise, Herbe ...; Ha Visser, Gerar ...; Wee, Ling; Wolf, Hans; Lees, Christoph ...; visa färre...

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Reproduktionsmed ...

Artiklar i publikationen: BMJ Open

Av lärosätet: Uppsala universitet; Lunds universitet; Karolinska Institutet

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