Study on adequate identification of the term fetus at risk due to intra uterine growth restriction.
Completed
- Conditions
- fetal growth restrictionIntra uterine growth restriction10016849
- Registration Number
- NL-OMON37891
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
Gestational age >34 weeks, suspected of growth restriction defined as an estimated fetal weight or fetal abdominal circumference below the 10th population percentile measured by ultrasound twice, with at least 7 days between both measurements.
Exclusion Criteria
Known chromosomal and/or structural anomaly
Multiple gestation
Antenatal intra-uterine infection
Signs of an intra-uterine infection during labour, defined as a maternal rectal temperature > 38.5 C° AND fetal tachycardia on CTG with fetal heart rate above 170 beats per minute.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite measure of adverse outcome (mortality AND/OR asphyxia defined as<br /><br>pH<7.05 AND/OR Apgar at 5 minutes <7 AND/OR admission to NICU AND/OR antepartum<br /><br>obstetrical intervention for suspected fetal distress)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Neonatal neurobehavioral development.<br /><br>- Ponderal index<br /><br>- Catch up growth (after 4-6 months)<br /><br>- Metabolomics</p><br>