Fetal brain imaging in fetuses at high risk of acquired anomalies

Fetal brain imaging in fetuses at high risk of acquired anomalies - Fetal Brain Imaging, FBI-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35261

Enrollment

400

Registered

2010-05-11

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

acquired fetal brain damage

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: zwangeren waarbij een infectie is aangetoond (toxoplasmose, cytomegalie), trauma hebben ondergaan of trombocytopenie (allo-immuun) of bij de foetus een groeirestrictie is aangetoond onder de 10de percentiel voor 30 weken zwangerschapsduur, hydrops (verdacht voor anemie, arythmie, parvo virus infectie of hydrothorax), monochriale tweeling, echoscopische hersenbevindingen passend bij verkregen afwijking.

Exclusion criteria

Exclusion criteria: age below 18 years serious language or communication barrier pacemaker (with respect to MRI) familial chromosomal, syndromal or metabolic abnormality confirmed chromosomal abnormality suspected syndromal or metabolic abnormality

Design outcomes

Primary

Measure	Time frame
What is the added value of transvaginal ultrasound or MRI to abdominal ultrasound in a fetus at thig risk of deveoping brain damage in the second and third trimester of pregnancy.	—

Secondary

Measure	Time frame
What is the prevalence of changes visible on antenatal ultrasound in the areas in the brain that are prone to hypoxic ischemic damage after birth. What is the evolution of these changes over time before and after birth. Which antenatal ultrasound findings are associated with abnormal neurological development until five years of age. At which gestational age can brain damage best be determined with transabdominal and transvaginal ultrasound and MRI. Which brain imaging procedures have the best predictive value for the neurological outcome at two and five uears of age and how are they related cost-effectively.	—

Measure

Time frame

What is the prevalence of changes visible on antenatal ultrasound in the areas in the brain that are prone to hypoxic ischemic damage after birth. What is the evolution of these changes over time before and after birth. Which antenatal ultrasound findings are associated with abnormal neurological development until five years of age. At which gestational age can brain damage best be determined with transabdominal and transvaginal ultrasound and MRI. Which brain imaging procedures have the best predictive value for the neurological outcome at two and five uears of age and how are they related cost-effectively.

—

Countries

Netherlands

Outcome results