Trial record 2 of 23 for:    ultrasound [TREATMENT] AND prenatal [ALL-FIELDS] | Open Studies

Outcome of Fetal Spina Bifida

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Luebeck
Sponsor:
Information provided by (Responsible Party):
Daniel Alexander Beyer, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01100697
First received: April 2, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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
Pregnancy
Fetal and Neonatal Health

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fetal Spina Bifida -Prenatal Course and Outcome in 103 Cases A Single Center Experience.

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • pregnancy outcome [ Time Frame: 17 yrs ] [ Designated as safety issue: No ]
    To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.

  • Infant psychomotor development [ Time Frame: 17 yrs ] [ Designated as safety issue: No ]

    Kaufmann ABC

    Denver Developmental Screening Test

    walking ability

    muscle strenght


  • Infant bladder and bowel function [ Time Frame: 17 yrs ] [ Designated as safety issue: No ]
    Degree of continence.


Secondary Outcome Measures:
  • Conception date [ Time Frame: 17 yrs ] [ Designated as safety issue: No ]
  • spectrum of ultrasound signs [ Time Frame: 17yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: December 2009
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   12 Weeks to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100697

Contacts
Contact: Feriel Amari, M.D. +49 451 500 2141 feriel.amari@uk-sh.de
Contact: Klaus Diedrich, PhD +49 451 500 2141 klaus.diedrich@uk-sh.de

Locations
Germany
Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine Recruiting
Lübeck, Schleswig- Holstein, Germany, D- 23538
Contact: Feriel Amari, M.D.    + 49 451 989 2663    feriel.amari@uk-sh.de   
Sub-Investigator: Daniel Beyer, M.D.         
Sub-Investigator: David Hartge, M.D.         
Sub-Investigator: Martin Krapp, PhD         
Sub-Investigator: Ute Germer, PhD         
Sub-Investigator: Ulrich Gembruch, PhD         
Sub-Investigator: Roland Axt-Fliedner, PhD         
Principal Investigator: Jan Weichert, M.D.         
Principal Investigator: Feriel Amari, M.D.         
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: April 2, 2010
Last Updated: September 10, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014