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Obstetrics & Gynecology 2006;108:1115-1120
© 2006 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Sample Bias Among Women With Retained DNA Samples for Future Genetic Studies

Kjersti Aagaard-Tillery, MD, PhD1, Baha Sibai, MD2, Catherine Y. Spong, MD3, Valerija Momirova, MS4, George Wendel, Jr, MD5, Katharine Wenstrom, MD6, Philip Samuels, MD7, Margaret Cotroneo, RN8, Atef Moawad, MD9, Yoram Sorokin, MD10, Menachem Miodovnik, MD11, Paul Meis, MD12, Mary J. O’Sullivan, MD13, Deborah Conway, MD14, Ronald J. Wapner, MD15 for the National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network*

From the 1Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah; 2University of Tennessee, Memphis, Tennessee; 3National Institute for Child Health and Human Development; Rockville, Maryland, 4Biostatistics Coordinating Center, George Washington University, Washington, DC; and the Departments of Obstetrics and Gynecology, 5University of Texas—Southwestern, Dallas, Texas, 6University of Alabama at Birmingham, Birmingham, Alabama; 7Ohio State University, Columbus, Ohio, 8Magee Women’s Hospital/University of Pittsburgh, Pittsburgh, Pennsylvania, 9University of Chicago, Chicago, Illinois, 10Wayne State University, Detroit, Michigan, 11University of Cincinnati, Cincinnati, Ohio, 12Wake Forest University, Winston-Salem, North Carolina, 13University of Miami, Coral Gables, Florida, 14University of Texas—San Antonio, San Antonio, Texas, and 15Thomas Jefferson University, Philadelphia, Pennsylvania.

OBJECTIVE: To evaluate whether women who agree to future use of their biologic specimens for genetic studies reflect the larger study population from which they are derived.

METHODS: Women were questioned as to the future disposition of their maternal and fetal DNA samples upon enrollment in a multicenter, observational study originally designed to identify factor V Leiden mutation carriers and prospectively ascertain the estimated rate of pregnancy-related venous thromboembolism and adverse pregnancy outcome. Univariate and multivariate analyses was carried out on the 5,003 of 5,188 enrolled women who indicated their desire regarding future disposition of their DNA samples.

RESULTS: Among these 5,003 women, 20.1% desired that their samples be discarded and not available for future genetic studies. Multivariate analysis demonstrated that women who agreed to subsequent use of samples were less likely African-American (odds ratio [OR] 0.6, 95% confidence interval [CI] 0.4–0.7) or Hispanic (OR 0.4, 95% CI 0.3–0.5), and more likely to use tobacco (OR 1.2, 95% CI 1.0–1.6) than those who desired that their samples be discarded.

CONCLUSION: Genetic samples from women agreeing to their use in a sample repository may not be representative of the index study cohort. This should be considered in their subsequent interpretation and generalizability.

LEVEL OF EVIDENCE: III






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