Outcome of Fetal Spina Bifida

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100697
• Other study ID #: UKSH-HL-09-181
• Status: Completed
• Start date: December 2009
• Est. completion date: October 1, 2015

Study information

• Verified date: May 2018
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 1, 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Weeks to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal and Neonatal Health
• Pregnancy
• Spinal Dysraphism

Locations

Country	Name	City	State
Germany	Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine	Lübeck	Schleswig- Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy outcome	To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.	17 yrs
Primary	Infant psychomotor development	Kaufmann ABC; Denver Developmental Screening Test; walking ability; muscle strenght	17 yrs
Primary	Infant bladder and bowel function	Degree of continence.	17 yrs
Secondary	Conception date		17 yrs
Secondary	spectrum of ultrasound signs		17yrs