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Outcome of Fetal Spina Bifida

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100697
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : May 3, 2018
Information provided by (Responsible Party):
Daniel Alexander Beyer, University of Luebeck

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.

Condition or disease
Pregnancy Fetal and Neonatal Health

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fetal Spina Bifida -Prenatal Course and Outcome in 103 Cases A Single Center Experience.
Study Start Date : December 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spina Bifida

thoracal lesion
spinal lesion at thoracal level detected at prenatal ultrasound exam
lumbar lesion
spinal lesion at lumbar level detected at prenatal ultrasound exam
sacral lesion
spinal lesion at sacral level detected at prenatal ultrasound exam

Primary Outcome Measures :
  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 Outcome Measures :
  1. Conception date [ Time Frame: 17 yrs ]
  2. spectrum of ultrasound signs [ Time Frame: 17yrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Weeks to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fetuses with spina bifida identified at prenatal ultrasound examination between 1993 and 2009

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01100697

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Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine
Lübeck, Schleswig- Holstein, Germany, D- 23538
Sponsors and Collaborators
University of Luebeck
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Principal Investigator: Feriel Amari, M.D. Schleswig- Holstein University, Lübeck
Study Director: Jan Weichert, M.D. Schleswig- Holstein University, Lübeck
Study Chair: Klaus Diedrich, PhD Schleswig- Holstein University, Lübeck

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Daniel Alexander Beyer, Dr. D. A. Beyer, University of Luebeck Identifier: NCT01100697     History of Changes
Other Study ID Numbers: UKSH-HL-09-181
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Keywords provided by Daniel Alexander Beyer, University of Luebeck:
prenatal diagnosis
spina bifida
neural tube defect
Additional relevant MeSH terms:
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Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities