Pregnancy/foetal growth restriction Pregnancy and Childbirth Maternal care for other known or suspected foetal problems
Conditions
Interventions
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
Sponsors
Addenbrooke's Hospital (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria, Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed