Outcome of Fetal Spina Bifida

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine
Lübeck, Schleswig- Holstein, Germany, D- 23538

Sponsors and Collaborators

University of Luebeck

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Cameron M, Moran P. Prenatal screening and diagnosis of neural tube defects. Prenat Diagn. 2009 Apr;29(4):402-11. doi: 10.1002/pd.2250. Review.

D'Addario V, Rossi AC, Pinto V, Pintucci A, Di Cagno L. Comparison of six sonographic signs in the prenatal diagnosis of spina bifida. J Perinat Med. 2008;36(4):330-4. doi: 10.1515/JPM.2008.052.

Biggio JR Jr, Owen J, Wenstrom KD, Oakes WJ. Can prenatal ultrasound findings predict ambulatory status in fetuses with open spina bifida? Am J Obstet Gynecol. 2001 Nov;185(5):1016-20.

Peralta CF, Bunduki V, Plese JP, Figueiredo EG, Miguelez J, Zugaib M. Association between prenatal sonographic findings and post-natal outcomes in 30 cases of isolated spina bifida aperta. Prenat Diagn. 2003 Apr;23(4):311-4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beyer DA, Diedrich K, Weichert J, Kavallaris A, Amari F. Seasonality of spina bifida in Northern Germany. Arch Gynecol Obstet. 2011 Oct;284(4):849-54. doi: 10.1007/s00404-010-1762-0. Epub 2010 Nov 16.

Responsible Party:	Daniel Alexander Beyer, Dr. D. A. Beyer, University of Luebeck
ClinicalTrials.gov Identifier:	NCT01100697 History of Changes
Other Study ID Numbers:	UKSH-HL-09-181
First Posted:	April 9, 2010
Last Update Posted:	March 14, 2017
Last Verified:	March 2017

Keywords provided by Daniel Alexander Beyer, University of Luebeck:

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

Additional relevant MeSH terms:

Spinal Dysraphism; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities