Abnormal number of fetal ribs or vertebrae and associated congenital abnormalities and adverse fetal outcome; The need for prenatal detection of rib and vertebral abnormalities by 2D&3D-ultrasound.

Abnormal number of fetal ribs or vertebrae and associated congenital abnormalities and adverse fetal outcome; The need for prenatal detection of rib and vertebral abnormalities by 2D&3D-ultrasound. - ASAP (Abnormal Spine And Prognosis)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40300

Enrollment

260

Registered

2014-04-24

Start date

2014-05-19

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

rib and vertebral anomalies vertebral column abnormalities

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women - with a gestational age of at least 12 weeks - of at least 18 years old - who are mentally competent - who are willing to sign the informed consent form

Exclusion criteria

Exclusion criteria: Language barrier No consensus on interpretation of ultrasound or Xrays between different observers Insufficient ossification (taking visibility of ossification centres of the phalanges as a reference)

Design outcomes

Primary

Measure	Time frame
The number of ribs and/or vertebrae in fetuses with and without congenital malformations, aneuploidy and adverse fetal outcome.	—

Secondary

Measure	Time frame
Secondary objectives are to determine: i) the most suitable and earliest gestational age for assessing number of vertebrae and ribs and shape by ultrasound ii) whether it is feasible, when vertebral or rib anomalies are seen by ultrasound, to identify the level of anomalies in the vertebral column, i.e. cervical, thoracic or lumbar iii) whether there is an association between an abnormal number of ribs or vertebrae and abnormalities of specific organ systems iv) whether the severity of the malformations is correlated to the severity of the anomaly of the vertebral column v) whether anomalies in vertebral or rib number are associated with specific genetic anomalies vi) whether the malformations can be classified into recognizable phenotypic patterns which may be caused by or associated with a single genetic anomaly vii) whether genetic anomalies can be classified according to the vertebral level where the disruption occurs	—

Measure

Time frame

Secondary objectives are to determine: i) the most suitable and earliest gestational age for assessing number of vertebrae and ribs and shape by ultrasound ii) whether it is feasible, when vertebral or rib anomalies are seen by ultrasound, to identify the level of anomalies in the vertebral column, i.e. cervical, thoracic or lumbar iii) whether there is an association between an abnormal number of ribs or vertebrae and abnormalities of specific organ systems iv) whether the severity of the malformations is correlated to the severity of the anomaly of the vertebral column v) whether anomalies in vertebral or rib number are associated with specific genetic anomalies vi) whether the malformations can be classified into recognizable phenotypic patterns which may be caused by or associated with a single genetic anomaly vii) whether genetic anomalies can be classified according to the vertebral level where the disruption occurs

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Countries

Netherlands

Outcome results