ISRCTN76016200
Active, Not Recruiting
N/A
Perinatal and 2 year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 Randomised Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fetal growth restriction
- Sponsor
- Imperial College London
- Enrollment
- 638
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 27/07/2020:
- •All criteria should be fulfilled to be eligible for randomisation:
- •1\. Women \= 18 years old
- •2\. Pregnant with singleton non\-anomalous fetuses
- •3\. Between 32\+0 and 36\+6 weeks of gestation
- •4\. Estimated fetal weight or abdominal circumference \<10th percentile OR decreased by 50 percentiles since an ultrasound scan at 18\+0\-32\+0 weeks
- •5\. Cerebral redistribution defined as UCR \>1\.0 (32\+0\-33\+6 weeks) or \>0\.8 (34\+0\-36\+6 weeks) measured at least twice in any 24 hours period
- •6\. Normal STV on cCTG (4\.5 msec or above)
- •Previous inclusion criteria:
- •For screening:
Exclusion Criteria
- •Current exclusion criteria as of 27/07/2020:
- •1\. Indication for immediate delivery required within 48 hours
- •2\. Unable to give informed consent
- •3\. Preterm prelabour rupture of the membranes (PPROM)
- •4\. Suspected placental abruption or antepartum haemorrhage
- •5\. Presence of reversed end diastolic flow in the Umbilical Artery
- •Previous exclusion criteria:
- •1\. Indication for immediate delivery within 48 hours
- •2\. Unable to give informed consent
- •3\. Preterm prelabour rupture of the membranes (PPROM)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
N/A
ong-term neurodevelopmental outcome after perinatal arterial ischemic strokeperinatal arterial ischemic stroke (PAIS)neonatal stroke1000796310028920NL-OMON55959niversitair Medisch Centrum Utrecht50
Completed
N/A
ate neonatal neurological outcome in infants with prenatally diagnosed duct dependent CHD and its relation with fetal and neonatal cerebral perfusioNL-OMON40142niversitair Medisch Centrum Groningen25
Recruiting
N/A
Onderzoek naar de bloedvoorziening van de hersenen bij kinderen met een aangeboren hartafwijkingCongenital heart disease, ductus arteriosus, near-infrared spectroscopy, Doppler flow profiles, general movements, Prechtl's method, neurological outcome, neonateCongenitale hartafwijkingen, ductus arteriosus, near-infrared spectroscopy, Doppler flow profielen, general movements, Prechtl's methode, neurologische ontwikkeling, neonaatNL-OMON23653niversity Medical Center Groningen25
Completed
N/A
Growth and Neurodevelopment Outcome of IUGR preterm infants (<35 weeks) with abnormal doppler studies at 1 year of corrected ageCTRI/2009/091/000509one300
Completed
N/A
Early neurological outcome of prenatally diagnosed ventriculomegaly at 20 weeks of gestation standardized ultrasound scaenlarged brain ventriclesVentriculomegaly100292991004225810016849NL-OMON38456niversitair Medisch Centrum Groningen24