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

Mylrea-Foley, B. ; Marsal, Karel LU and Lees, C.C. (2022) In BMJ Open 12(4).
Abstract
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... (More)
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 (Less)
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keywords
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
in
BMJ Open
volume
12
issue
4
article number
e055543
publisher
BMJ Publishing Group
external identifiers
  • scopus:85128487699
  • pmid:35428631
ISSN
2044-6055
DOI
10.1136/bmjopen-2021-055543
language
English
LU publication?
yes
id
2dfe30f7-e48e-4e56-89c3-d75624d9b123
date added to LUP
2022-09-12 09:19:02
date last changed
2022-09-13 03:00:06
@article{2dfe30f7-e48e-4e56-89c3-d75624d9b123,
  abstract     = {{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}},
  author       = {{Mylrea-Foley, B. and Marsal, Karel and Lees, C.C.}},
  issn         = {{2044-6055}},
  keywords     = {{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}},
  language     = {{eng}},
  number       = {{4}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: The TRUFFLE 2 randomised trial protocol}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2021-055543}},
  doi          = {{10.1136/bmjopen-2021-055543}},
  volume       = {{12}},
  year         = {{2022}},
}