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  "name": "TRUFFLE trial (timing of birth in early fetal growth restriction)",
  "aliases": [],
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  "summary_plain": "A European trial in women whose babies had severe growth restriction between 26 and 32 weeks of pregnancy. It tested three plans for deciding when to deliver, based on heart-rate tracing or on blood flow in a vein in the baby. The main result at 2 years of age was not clearly different between plans.",
  "summary_technical": "Prospective, European, multicentre, unblinded, randomised study (ISRCTN 56204499; Lancet 2015). 503 of 542 eligible women were randomly allocated 1:1:1 to delivery plans based on reduced cardiotocography short-term variation, early ductus venosus Doppler changes (pulsatility index above the 95th percentile) or late ductus venosus changes. Primary outcome: survival without cerebral palsy, neurosensory impairment or Bayley III score below 85 at 2 years. The primary result was not significant (p trend 0.09); the authors describe a survivor-only difference and a non-significant increase in mortality. This trial tested ductus venosus Doppler against cardiotocography, not umbilical artery Doppler (a high umbilical artery pulsatility index was an entry criterion). Funded by ZonMw and the Dr Hans Ludwig Geisenhofer Foundation.",
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      "care-area": [
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  "payload": {
    "design": "Prospective, European multicentre, unblinded, randomised study of women with singleton fetuses at 26 to 32 weeks with very preterm fetal growth restriction, allocated 1:1:1 (randomly sized blocks, stratified by centre and by gestational age below or at least 29 weeks) to three timing-of-delivery plans that differed in antenatal monitoring strategy. Intention to treat for the primary outcome.",
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    "start_date": null,
    "primary_completion_date": null,
    "completion_date": null,
    "results_first_posted": null,
    "countries": [
      {
        "code": "GB",
        "snapshot": "maternal:truffle-isrctn-2026-10-14"
      },
      {
        "code": "AT",
        "snapshot": "maternal:truffle-isrctn-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "maternal:truffle-isrctn-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "maternal:truffle-isrctn-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "maternal:truffle-isrctn-2026-10-14"
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    "enrollment": [
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        "count": 503,
        "basis": "randomized",
        "unit": "women (randomly allocated from 542 eligible)",
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    "arms": [
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        "label": "Delivery on reduced cardiotocography short-term variation",
        "intervention": null,
        "description": "Delivery timed by reduced fetal heart-rate short-term variation on cardiotocography (CTG STV); 166 women allocated."
      },
      {
        "id": "maternal:truffle-trial-arm-dv-early",
        "label": "Delivery on early ductus venosus Doppler changes",
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        "description": "Delivery timed by early ductus venosus changes (pulsatility index above the 95th percentile; DV p95); 167 women allocated."
      },
      {
        "id": "maternal:truffle-trial-arm-dv-late",
        "label": "Delivery on late ductus venosus Doppler changes",
        "intervention": null,
        "description": "Delivery timed by late ductus venosus changes (A wave at or below baseline; DV no A); 170 women allocated."
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      "statement": "TRUFFLE randomly allocated 503 of 542 eligible women (singleton fetus at 26 to 32 weeks with very preterm growth restriction) to three delivery-timing plans based on reduced cardiotocography short-term variation, early ductus venosus Doppler changes, or late ductus venosus Doppler changes. The primary outcome, survival without cerebral palsy, neurosensory impairment or a Bayley III score below 85 at 2 years, did not differ between groups: 111 of 144 infants with known outcome (77%) in the cardiotocography group, 119 of 142 (84%) in the early ductus group and 133 of 157 (85%) in the late ductus group (p trend 0.09). The authors call the difference non-significant at the primary endpoint.",
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