No registrations found.
ID
Source
Brief title
Health condition
Fetal growth restrion, foetale groeirestrictie
Sponsors and support
Intervention
Outcome measures
Primary outcome
7-point average difference MDI/PDI Bayley-III at 2 years
Secondary outcome
Composite outcome of neonatal morbidity appropriate for late preterm gestations, perinatal mortality, mode of delivery, maternal quality of life, costs.
Background summary
NA
Study objective
Implementation of UCR as diagnostic marker for fetal compromise in SGA improves long-term neurodevelopmental outcome by identifying fetuses with fetal growth restriction (FGR) within the SGA group who will benefit from earlier delivery, improving health outcomes and saving healthcare resources.
Study design
Primary:
- 7-point average difference MDI/PDI Bayley-III (timepoint: 2 years)
Secondary
- Registry of neonatal morbidity, perinatal mortality, mode of delivery (timepoint: perinatal/neonatal period)
Intervention
Delivery at 36 weeks when UCR is abnormal and fetal growth is mildly abnormal (EFW/FAC p3-p10) and delivery at 34 weeks when UCR is abnormal and fetal growth is severely abnormal (EFW/FAC below p3).
Inclusion criteria
o Inclusion criteria cohort:
- Singleton pregnancy
- Identified SGA (estimated fetal weight or fetal abdominal circumference below 10th percentile)
- 32+0 – 37+0 weeks of gestation
o Inclusion in RCT (in addition to the above-mentioned criteria)
- Abnormal UmbilicoCerebral Ratio (UCR): ≥0.8 on at least 2 occasions with an interval of at least one day
AND
- EFW and/or FAC
Exclusion criteria
- Maternal age <18 years
- Multiple pregancies
- Suspicion of congenital abnormalities
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6475 |
| NTR-old | NTR6663 |
| Other | Projectnumber ZonMw : 843002825 |