DRIGITAT: Doppler Ratio In fetal Growth restriction Intervention Trial At (near) Term
- Conditions
- Fetal growth restrion, foetale groeirestrictie
- Registration Number
- NL-OMON29445
- Lead Sponsor
- Academisch Medische Centrum (AMC) - Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 185
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 OR
- EFW and/or FAC <p10 AND 36+0 – 37+0 weeks of gestation
Exclusion Criteria
- Maternal age <18 years
- Multiple pregancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 7-point average difference MDI/PDI Bayley-III at 2 years
- Secondary Outcome Measures
Name Time Method Composite outcome of neonatal morbidity appropriate for late preterm gestations, perinatal mortality, mode of delivery, maternal quality of life, costs.