Outcome of Fetal Spina Bifida

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Fetal and Neonatal Health

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Fetuses with spina bifida identified at prenatal ultrasound examination between 1993 and 2009

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy outcome	To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.	17 yrs
Infant psychomotor development	Kaufmann ABC Denver Developmental Screening Test walking ability muscle strenght	17 yrs
Infant bladder and bowel function	Degree of continence.	17 yrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Conception date	17 yrs
spectrum of ultrasound signs	17yrs

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.
• 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. doi: 10.1067/mob.2001.117676.
• 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. doi: 10.1002/pd.584.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 2, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: ultrasound; outcome; prenatal diagnosis; spina bifida; neural tube defect
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: UKSH-HL-09-181