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OpenTrials
Completed

NCT Number: NCT01100697

Outcome of Fetal Spina Bifida

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.

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Key information

Age range

12 week–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine

Lübeck, Schleswig-Holstein, D- 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. pregnancy outcome

    Time frame: 17 yrs

    To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.

  2. Infant psychomotor development

    Time frame: 17 yrs

    Kaufmann ABC

    Denver Developmental Screening Test

    walking ability

    muscle strenght

  3. Infant bladder and bowel function

    Time frame: 17 yrs

    Degree of continence.

Secondary outcomes

  1. Conception date

    Time frame: 17 yrs

  2. spectrum of ultrasound signs

    Time frame: 17yrs

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Apr 9, 2010
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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