Clinical trial NCT01100697: Outcome of Fetal Spina Bifida
Official title: Fetal Spina Bifida -Prenatal Course and Outcome in 103 Cases A Single Center Experience.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Fetal and Neonatal Health
Keywords: prenatal diagnosis
ultrasound
outcome
spina bifida
neural tube defect
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 103
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fetuses with spina bifida identified at prenatal ultrasound examination between 1993 and 2009

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.


Eligibility 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

Primary outcomes:
measure: pregnancy outcome
timeFrame: 17 yrs
measure: Infant psychomotor development
timeFrame: 17 yrs
measure: Infant bladder and bowel function
timeFrame: 17 yrs
Secondary outcomes:
measure: Conception date
timeFrame: 17 yrs
measure: spectrum of ultrasound signs
timeFrame: 17yrs
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine
state: Schleswig- Holstein
Study officials:
affiliation: Schleswig- Holstein University, Lübeck
name: Feriel Amari, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Schleswig- Holstein University, Lübeck
name: Jan Weichert, M.D.
role: STUDY_DIRECTOR
affiliation: Schleswig- Holstein University, Lübeck
name: Klaus Diedrich, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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. doi: 10.1002/pd.584.
citation: 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.