Study on adequate identification of the term fetus at risk due to intra uterine growth restriction.

Study on adequate identification of the term fetus at risk due to intra uterine growth restriction. - SAFARI study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37891

Enrollment

500

Registered

2012-08-13

Start date

2012-11-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fetal growth restriction Intra uterine growth restriction

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Composite measure of adverse outcome (mortality AND/OR asphyxia defined as pH	—

Secondary

Measure	Time frame
- Neonatal neurobehavioral development. - Ponderal index - Catch up growth (after 4-6 months) - Metabolomics	—

Countries

Netherlands

Outcome results