Trial of Umbilical and Foetal Flow in Europe: TRUFFLE study
| ISRCTN | ISRCTN56204499 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56204499 |
| Secondary identifying numbers | Lancet Protocol 02PRT/34 |
- Submission date
- 04/06/2009
- Registration date
- 27/08/2009
- Last edited
- 11/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Christoph Lees
Scientific
Scientific
Centre for Fetal Care
Queen Charlottes and Chelsea Hospital
Imperial College Healthcare NHS Trust
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0) 20 8383 3998 |
|---|---|
| Christoph.Lees@imperial.nhs.uk |
Study information
| Study design | Multicentre three-armed randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Can be found at https://trufflestudy.org/truffle/docutruffle/TrufflePatientInformation.pdf |
| Scientific title | Trial of Umbilical and Foetal Flow in Europe: a multicentre three-armed randomised controlled trial |
| Study acronym | TRUFFLE |
| Study objectives | 1. That among preterm growth-restricted babies, timing delivery when the foetal ductus venosus Doppler pulsatility index reaches the 95th centile increases the rate of normal infant neurodevelopmental outcome compared with delivery timing based on foetal heart short-term variation alone. 2. That among preterm growth-restricted babies, timing delivery when the foetal ductus venosus Doppler pulsatility index reaches a late stage of abnormality (a-wave reaching the baseline) increases the rate of normal infant neurodevelopmental outcome compared with delivery timing based on foetal heart short-term variation alone. 3. That among preterm growth-restricted babies, delaying delivery until the foetal ductus venosus Doppler pulsatility index reaches a late stage of abnormality (a-wave reaching the baseline) increases the rate of normal infant neurodevelopmental outcome compared with delivering when the foetal ductus venosus Doppler pulsatility index reaches the 95th centile. On 28/01/2011 this record was updated to include the actual end date of the trial; the previous anticipated end date of this trial was 01/01/2010. On 28/04/2014 the anticipated end date was changed to 31/12/2013 (end of follow-up). |
| Ethics approval(s) | Multicentre Research Ethics Committee approved in September 2005 (ref: 05/Q0803/152). All other centres will obtain ethics approval prior to recruitment. |
| Health condition(s) or problem(s) studied | Pregnancy/foetal growth restriction |
| Intervention | This is a randomised multicentre study of timing delivery in women in whom intrauterine growth restriction is found on ultrasound scan at gestations between 26 and 32 weeks. Trial entry is stratified by gestational age at enrolment. The intervention is delivery of the foetus, based on the criteria detailed below: Group 1: control intervention, current standard of care: the timing of delivery is based on cardiotocography criteria for delivery, namely short-term variation below preset cut-offs based on gestation Group 2a: delivery based on early ductus venosus changes (pulsatility index greater than 95th centile) Group 2b: delivery based on late ductus venosus changes (a-wave reaches the baseline, i.e. 0 cm/s) |
| Intervention type | Other |
| Primary outcome measure | Survival without neurodevelopmental impairment at 2 years of age corrected for prematurity. Such impairment is defined as any of the following: 1. A standardised score of 70 or less on the Cognitive Scale from the Bayley Scale of Infant Development 3rd edition (i.e., more than 2 standard deviations below the mean) 2. Severe visual loss (legally certifiable as blind or partially sighted) 3. Cerebral palsy with a score of 2 or greater on the Gross Motor Function Classification System 4. Deafness requiring hearing aids |
| Secondary outcome measures | Long-term outcomes at 2 years age corrected for prematurity include: 1. The frequency of severe disability (Bayley score of 55 or less; severe cerebral palsy [Gross Motor Function classification systems - GMFCS] 4 or 5; blind; profound deafness) 2. Respiratory outcomes: days on home oxygen after discharge home, need for inhaled medications, hospital admissions 3. Weight, length, and head circumference (expressed as standard deviation scores) 4. Blood pressure 5. Other disability not classifiable as neurodevelopmental in origin 6. Survival analysis curves from study entry will be compared for a composite neonatal morbidity and mortality (to 28 days of life) and for mortality to 2 years, with hazard ratios and Cox's proportional model 7. Prespecified subgroup analyses include analysis by foetal sex, gestational age at delivery (less than 29 weeks; greater than 29 weeks) and indication for delivery |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 500 |
| Key inclusion criteria | 1. The pregnancy should be singleton (i.e., not multiple pregnancy) 2. No obvious major structural abnormalities should have been identified on ultrasound 3. Certain menstrual age and/or ultrasound assessment of gestational age 4. The pregnancy should have reached at least 26 weeks gestation, but not yet 32 weeks of gestation by the time of recruitment 5. The ultrasound estimation of foetal weight should be at least 500 g at entry of the study 6. There should be ultrasound evidence of growth restriction, defined as a foetal abdominal circumference measurement under the 10th centile 7. Short term variability of the foetal heart rate after 1 hour recording should be greater than 3.5 beats per minute at 26 - 29 weeks, and greater than 4 beats per minute at 30 - 32 weeks 8. There should be evidence of abnormal umbilical artery bloodflow, manifesting as Umbilical arterial Doppler velocimetry above 95th centile 9. The foetal Ductus Venosus waveform using doppler ultrasound, should be normal defined as a venous pulsatility index under the 95th centile 10. There should be no obvious indication for immediate delivery (such as uncontrolled maternal high blood pressure) 11. The patient must be able to give informed consent to participation |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Austria
- England
- Germany
- Italy
- Netherlands
- United Kingdom
Study participating centre
Centre for Fetal Care
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Addenbrooke's Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Cambridge
CB2 2QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html |
|---|---|
"ROR" |
https://ror.org/055vbxf86 |
Funders
Funder type
Research organisation
Dutch Council for Medical Research (Netherlands) - fully funding Dutch Centres
No information available
Central trial administration is funded through small donations, awards and proceeds from educational courses
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | results | 30/05/2015 | Yes | No |
