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Bias Toward the Null Hypothesis in Pregnancy Drug Studies That Do Not Include Data on Medical Terminations of Pregnancy: The Folic Acid Antagonists.
MedLine Citation:
PMID:  21343345     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Most studies on safety/risk of drugs in pregnancy consider the proportion of births (but not pregnancy terminations) affected by the drug from all exposed infants. Lack of data on pregnancy terminations could bias results. A computerized database for medications dispensed to pregnant women in southern Israel was linked with records from the district hospital; 84 823 deliveries and 998 medical pregnancy terminations took place; 571 of the women were exposed to folic acid antagonists in the first trimester. When only births were examined, there was no association between folic acid antagonists and fetal malformations. When data on pregnancy terminations were examined and births and pregnancy terminations were combined, there was a significant risk (neural tube defects: odds ratio 18.83, 95% confidence interval 9.24-38.37; cardiovascular defects: odds ratio 3.86, 95% confidence interval 1.67-8.88; and neural tube defects: odds ratio 6.30, 95% confidence interval 3.34-9.15; cardiovascular defects: odds ratio 1.76, 95% confidence interval 1.05-2.92, respectively). Inclusion of only birth data in observational studies of drugs in pregnancy constitutes a source of bias toward the null hypothesis.
Authors:
Amalia Levy; Ilan Matok; Rafael Gorodischer; Michael Sherf; Arnon Wiznitzer; Elia Uziel; Gideon Koren
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-2-22
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  -     ISSN:  1552-4604     ISO Abbreviation:  -     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-2-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Ben-Gurion University of the Negev.
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