Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Genetics of Spina Bifida and Anencephaly

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Duke University
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636233
First received: March 9, 2008
Last updated: June 22, 2016
Last verified: June 2016

March 9, 2008
June 22, 2016
May 1993
May 2020   (final data collection date for primary outcome measure)
genetic factors associated with neural tube defects [ Time Frame: end of the study ] [ Designated as safety issue: No ]
This study aims to discover genetic factors associated with neural tube defects such as anencephaly.
Not Provided
Complete list of historical versions of study NCT00636233 on ClinicalTrials.gov Archive Site
Not Provided
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Genetics of Spina Bifida and Anencephaly
The Hereditary Basis of Neural Tube Defects
The goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. Ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.

Participation in the study is entirely voluntary.

Individuals who are currently pregnant and the pregnancy has been diagnosed with anencephaly or acrania quality to participate.

Participation involves:

  1. Completing a written consent form
  2. A phone conversation to collect family and medical information
  3. Collection of blood samples from both parents of the pregnancy
  4. Provide a fetal DNA sample (cord blood, fetal tissue or amniotic fluid)
  5. Review of medical records and ultrasound images
Observational
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Whole blood, serum, saliva, cord blood, fetal tissue, cultured fetal cells
Probability Sample
Any current pregnancy affected by anencephaly or acrania.
  • Anencephaly
  • Acrania
Not Provided
Anencephaly
Fetuses with anencephaly, parents and siblings
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
May 2020
May 2020   (final data collection date for primary outcome measure)

Inclusion criteria: Current pregnancy diagnosed with anencephaly or acrania.

Exclusion criteria: Does not qualify if pregnancy has already ended and DNA sample is not available.

Both
Child, Adult, Senior
No
Contact: Heidi Cope, MS, CGC 919-684-0655 heidi.cope@duke.edu
United States
 
NCT00636233
Pro00016517, R01NS039818
No
No
Not Provided
Duke University
Duke University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Allison Ashley-Koch, PhD Duke University Health System
Duke University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP