title: Fetal monitoring indications for delivery and 2-year outcome in 310 infants with fetal growth restriction delivered before 32 weeks' gestation in the TRUFFLE study.
abstract: OBJECTIVE
  In the TRUFFLE (Trial of Randomized Umbilical and Fetal Flow in Europe) study on the outcome of early fetal growth restriction, women were allocated to one of three groups of indication for delivery according to the following monitoring strategies: (1) reduced fetal heart rate (FHR) short-term variation (STV) on cardiotocography (CTG); (2) early changes in fetal ductus venosus (DV) waveform (DV-p95); and (3) late changes in fetal DV waveform (DV-no-A). However, many infants per monitoring protocol were delivered because of safety-net criteria, for maternal or other fetal indications, or after 32 weeks of gestation when the protocol was no longer applied. The objective of the present posthoc subanalysis was to investigate the indications for delivery in relation to 2-year outcome in infants delivered before 32 weeks to further refine management proposals.
  
  
  METHODS
  We included all 310 cases of the TRUFFLE study with known outcome at 2 years' corrected age and seven fetal deaths, excluding seven cases with inevitable perinatal death. Data were analyzed according to the allocated fetal monitoring strategy in combination with the indication for delivery.
  
  
  RESULTS
  Overall, only 32% of liveborn infants were delivered according to the specified monitoring parameter for indication for delivery; 38% were delivered because of safety-net criteria, 15% for other fetal reasons and 15% for maternal reasons. In the CTG-STV group, 51% of infants were delivered because of reduced STV. In the DV-p95 group, 34% of infants were delivered because of abnormal DV and, in the DV-no-A group, only 10% of infants were delivered accordingly. The majority of infants in the DV groups were delivered for the safety-net criterion of spontaneous decelerations in FHR. Two-year intact survival was highest in the DV groups combined compared with the CTG-STV group (P = 0.05 for live births only, P = 0.21 including fetal death), with no difference between DV groups. A poorer outcome in the CTG-STV group was restricted to infants delivered because of FHR decelerations in the safety-net subgroup. Infants delivered because of maternal reasons had the highest birth weight and a non-significantly higher intact survival.
  
  
  CONCLUSIONS
  In this subanalysis of infants delivered before 32 weeks, the majority were delivered for reasons other than the allocated monitoring strategy indication. Since, in the DV group, CTG-STV criteria were used as a safety net but in the CTG-STV group, no DV safety-net criteria were applied, we speculate that the slightly poorer outcome in the CTG-STV group might be explained by the absence of DV data. The optimal timing of delivery of fetuses with early intrauterine growth restriction may therefore be best determined by monitoring them longitudinally, with both DV and CTG monitoring. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
authors.affiliation: Department of Perinatology, University Medical Center, Utrecht, The Netherlands.
authors.forename: G H A
authors.initials: GHA
authors.lastname: Visser
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Center, University of Groningen, Groningen, The Netherlands.
authors.forename: C M
authors.initials: CM
authors.lastname: Bilardo
authors.affiliation: Department of Perinatology, University Medical Center, Utrecht, The Netherlands.
authors.forename: J B
authors.initials: JB
authors.lastname: Derks
authors.affiliation: Department of Woman, Mother and Neonate, Buzzi Children's Hospital, University of Milan, Milan, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Ferrazzi
authors.affiliation: Maternal-Fetal Medicine Unit, University of Brescia, Brescia, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Fratelli
authors.affiliation: Department of Obstetrics and Gynecology, University Hospital, Parma, Italy.
authors.forename: T
authors.initials: T
authors.lastname: Frusca
authors.affiliation: Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: W
authors.identifier: http://orcid.org/0000-0002-7243-2115
authors.initials: W
authors.lastname: Ganzevoort
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.|Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
authors.forename: C C
authors.identifier: http://orcid.org/0000-0002-2104-5561
authors.initials: CC
authors.lastname: Lees
authors.affiliation: Department of Gynecology and Obstetrics, University Federico II of Naples, Naples, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Napolitano
authors.affiliation: Department of Obstetrics and Gynecology, Sant' Anna Hospital, Turin, Italy.
authors.forename: T
authors.initials: T
authors.lastname: Todros
authors.affiliation: Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Wolf
authors.affiliation: Department of Obstetrics and Fetal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Hecher
mesh_terms: D015148:Cardiotocography; D036861:Delivery, Obstetric; D005260:Female; D005317:Fetal Growth Retardation / Q000401:mortality* / Q000503:physiopathology; D005323:Fetal Monitoring; D005333:Fetus / Q000098:blood supply; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D009426:Netherlands; D011247:Pregnancy; D011256:Pregnancy Outcome; D011673:Pulsatile Flow; D016019:Survival Analysis; D016216:Ultrasonography, Prenatal; D014469:Umbilical Arteries / Q000000981:diagnostic imaging / Q000503:physiopathology*
keywords: cardiotocography; ductus venosus; fetal growth restriction; fetal heart rate variation; preterm delivery