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
 

 

TRUFFLE study

 

Trial of Umbilical and Fetal Flow in Europe

Go to the TRUFFLE website

How to decide the best timing of delivery in preterm pregnancies complicated by intrauterine growth restriction

Background
Optimal management of severe early fetal growth restriction is one of the greatest challenges in Obstetrics. In case of abnormal fetal monitoring obstetricians are often uncertain when to deliver these babies and how to balance between the complications of extreme preterm delivery and the risks of prolonged intrauterine exposure to malnutrition, hypoxia and the risk of death. Prospective observational research by the study group and others has provided evidence that Doppler measurement of the fetal ductus venosus (DV) maybe the best parameter to guide timing of delivery in these pregnancies.However this hypothesis needs further evidence.

Objective
The objective of this multi-centre randomised protocol, approved by the Lancet, is to determine which technique results in optimal timing of delivery of early preterm growth restricted infants: DV measurement (two different cut-offs - 1. mild or 2. severe abnormality- will be tested) or traditional monitoring based on 3. cardiotocography (STV). Criteria for inclusion aim at selecting a group of early and severe growth restricted fetuses. Randomisation will assign fetuses to the three branches.

Outcome measures and analysis
The primary outcome is normal neurological outcome at 2 years corrected age, without minor or major sequelae, examined by Griffith's Mental Developmental Scale. Two years is the earliest age to evaluate the infant development. The hypothesis of the study is that among preterm growth-restricted infants, timing delivery when the fetal DV is just marginally or severely abnormal,i.e. before the onset of severe fetal hypoxemia, increases the rate of normal infant neurological outcome compared with timing of delivery based on severe changes in fetal heart short-term variation.

The study will determine if timing delivery based on changes of fetal haemodynamic modifications monitored by venous Doppler velocimetry,where they precede a non-reassuring fetal heart rate pattern, is more effective than using computerised fetal heart rate monitoring.