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Outcome of Fetal Spina Bifida

Fetal Spina Bifida -Prenatal Course and Outcome in 103 Cases A Single Center Experience.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01100697
Enrollment
103
Registered
2010-04-09
Start date
2009-12-31
Completion date
2015-10-01
Last updated
2018-05-03

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

Conditions

Fetal and Neonatal Health, Pregnancy

Keywords

prenatal diagnosis, ultrasound, outcome, spina bifida, neural tube defect

Brief summary

Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to long-time survival. Concerning psychomotor development as well as urinary bladder and intestinal morbidity the prognosis ranges from normal functional outcome to severe disability. The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound screening allows patients to prepare for the birth of an impaired child or to consider termination of the pregnancy. In current practice, prenatal counseling and obstetric management depend not only on the detection of a spinal dysraphism but also on an appropriate assessment of the severity of the defect and its possible impact on the postnatal development of the affected child. Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on the postnatal outcome. Previous studies reported that postnatally determined lesion levels correlated well with functional status and survival. On the contrary, it is still not clear whether similar data obtained antenatally are of value. In this study, the investigators will review their database of all cases of prenatally diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the prenatal and postnatal characteristics of fetuses with spina bifida in relation to the anatomic level of the lesion, the investigators aim to contribute further information regarding the natural course of affected pregnancies and the correlation of prenatal ultrasound findings with their functional outcome.

Interventions

None listed

Sponsors

University of Luebeck
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Weeks to 12 Years
Healthy volunteers
No

Inclusion criteria

* spina bifida identified at prenatal ultrasound examination * ultrasound diagnosis between 1993 - 2009

Exclusion criteria

* deviant postnatal diagnosis * loss to follow-up * incomplete data

Design outcomes

Primary

MeasureTime frameDescription
pregnancy outcome17 yrsTo investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.
Infant psychomotor development17 yrsKaufmann ABC Denver Developmental Screening Test walking ability muscle strenght
Infant bladder and bowel function17 yrsDegree of continence.

Secondary

MeasureTime frame
Conception date17 yrs
spectrum of ultrasound signs17yrs

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026