Obstetrics

 
 APOSTEL VIII
 > Dutch TRUFFLE
 
 2Close
 
 APRIL
 Highlow
 
 PC
 Quadruple P
 
 SIMPLE III
 
 Stop or Go?
 
 STRIDER
 
 SUGAR-DIP
 
 KEUZEHULP IMPLEMENTATIE
 
 INDEX
 MOTHER
 NethOSS
 Ppromexil-III
 ALLO
 AMPHIA
 APOSTEL-I
 APOSTEL-II
 APOSTEL-III
 APOSTEL-IV
 
 Apostel VI
 ASB
 CHIPS
 DIGITAT
 ECV Implementation
 EuFis
 Fluxim
 GlucoMOMS
 HTA Longterm conseq.
 HTA Preference study
 HYPITAT
 HYPITAT-II
 HyRAS (Hypitat followup)
 Implementatie Tour
 IUPC
 PIMPP
 PPROMCerclage
 PPROMEXIL
 PreCare
 PROBAAT
 PROBAAT-II
 PROBAAT-S
 ProTWIN
 SimpleII
 STAN
 TeMpOH-1
 TeMpOH-3
 TOSTI
 TOTEM
 Triple P
 TRUFFLE
 WOMB study

 ABCD-study
 BIG CHANGE
 CAMPUR
 Cancer in pregnancy
 Doula study
 ECV tocolysis
 ECV Uterine relaxation
 EuroHeartSurvey
 FRUIT
 HP4ALL-PC
 HP4ALL-RS
 IMPACT
 INCAS
 IRIS
 Keizerlijk litteken
 MAKE
 OOPUS
 PRELHUDE
 PROMISES
 RAVEL
 SIMPLE
 STAN followup
 VET study
 VIS-project
 Wat bevalt beter
 ZAHARA II
 ZAHARA 3
 ZOBASII
 


Dutch TRUFFLE

 


 


The UmbilicoCerebral Ratio in late preterm Fetal Growth Restriction

 

Voor meer informatie en documenten, klik hier


 

Objective
Does, in late preterm fetuses identified as Small-for-Gestational-Age (SGA), timing of delivery based on abnormal UmbilicoCerebral Ratio (UCR) improve neurodevelopmental outcome?

Study design

Cohort of women with identified SGA pregnancies with a nested RCT in fetuses with abnormal UCR.

Study population
Cohort: Singleton pregnancies with identified SGA (EFW/FAC <p10), 32-37 weeks gestation
RCT: Identified SGA baby and abnormal UCR (>0.8), 34-37 weeks gestation

Intervention
Delivery from 34 weeks when UCR is abnormal and fetal growth is severely abnormal (EFW/FAC below p3) and delivery from 36 weeks when UCR is abnormal and fetal growth is mildly abnormal (EFW/FAC p3-p10).

Comparison

Delivery as per local protocol, usually from 38-40 weeks or later unless worsening of maternal/fetal condition prompts earlier delivery

Outcome measures
Primary: 7-point average difference MDI/PDI Bayley-3 at 2 years
Secondary: composite outcome of neonatal morbidity appropriate for late preterm gestations, perinatal mortality, mode of delivery, maternal quality of life, costs.

Power analysis
With an alpha of 0.05 and a beta of 0.8, calculated sample size is 74 for each arm of the nested RCT. Accounting for 20% loss to follow-up of randomized fetuses 185 women will be needed for the RCT in total. Assuming 20% incidence of abnormal UCR within the cohort of SGA-fetuses and accounting for an inclusion rate in the trial of 60% we calculate to need a cohort of 1542 patients.

Time schedule
01-2018 until 01-2020 inclusion period in cohort and nested RCT.
01-2020 until 01-2022 follow-up period for primary outcome

Projectleader(s)

Dr. J.W. Ganzevoort, Gynaecoloog-Perinatoloog, Academisch Medisch Centrum
Dr. S.J. Gordijn, Gynaecoloog-Perinatoloog, Universitair Medisch Centrum Groningen

Subsidy
ZonMw

Contact
Maddy Smies, Researcher, Academisch Medisch Centrum
E: m.smies@amc.uva.nl