Genetics of Spina Bifida and Anencephaly

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636233
First received: March 9, 2008
Last updated: September 11, 2014
Last verified: September 2014

March 9, 2008
September 11, 2014
May 1993
May 2015   (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 2015
May 2015   (final data collection date for primary outcome measure)

Any current pregnancy affected by anencephaly or acrania from which a DNA sample can be collected.

Both
Not Provided
No
Contact: Heidi Cope, MS, CGC 919-684-0655 heidi.cope@duke.edu
United States
 
NCT00636233
Pro00016517, R01 NS039818
No
Duke University
Duke University
Not Provided
Principal Investigator: Allison Ashley-Koch, PhD Duke University Health System
Duke University
September 2014

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