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Dutch TRUFFLE


- candidate number27746
- NTR NumberNTR6663
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-aug-2017
- Secondary IDs843002825 Projectnumber ZonMw
- Public TitleDutch TRUFFLE
- Scientific TitleDutch TRUFFLE: the UmbilicoCerebral Ratio in late preterm FetalGrowth Restriction
- ACRONYM
- hypothesisImplementation of UCR as diagnostic marker for fetal compromise in SGA improves long-term neurodevelopmental outcome by identifying fetuses with fetal growth restriction (FGR) within the SGA group who will benefit from earlier delivery, improving health outcomes and saving healthcare resources.
- Healt Condition(s) or Problem(s) studiedFetal growth restriction, Umbilical-cerebral ratio
- Inclusion criteriaInclusion in cohort:
- Singleton pregnancies with identified SGA (EFW/FAC - 32-37 weeks gestation Inclusion in nested RCT: - Singleton pregnancies with identified SGA (EFW/FAC
- Exclusion criteria- Maternal age <18 years
- Multiple pregancies
- Suspicion of congenital abnormalities
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-dec-2017
- planned closingdate1-jan-2022
- Target number of participants185
- InterventionsDelivery at 36 weeks when UCR is abnormal and fetal growth is mildly abnormal (EFW/FAC p3-p10) and delivery at 34 weeks when UCR is abnormal and fetal growth is severely abnormal (EFW/FAC below p3).
- Primary outcome7-point average difference MDI/PDI Bayley-III at 2 years
- Secondary outcomeComposite outcome of neonatal morbidity appropriate for late preterm gestations, perinatal mortality, mode of delivery, maternal quality of life, costs.
- TimepointsPrimary:
- 7-point average difference MDI/PDI Bayley-III (timepoint: 2 years)

Secondary
- Registry of neonatal morbidity, perinatal mortality, mode of delivery (timepoint: perinatal/neonatal period)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Maddy Smies
- CONTACT for SCIENTIFIC QUERIESDr. J.W. Ganzevoort
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-aug-2017 - 8-sep-2017


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