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Research Letter
March 18, 2019

Comparing Folic Acid Dosage Strengths to Prevent Reduction in Fetal Size Among Pregnant Women Who Smoked Cigarettes: A Randomized Clinical Trial

Author Affiliations
  • 1College of Nursing and Public Health, Adelphi University, Garden City, New York
  • 2Department of Family and Community Medicine, Baylor College of Medicine, Houston, Texas
  • 3College of Public Health, University of South Florida, Tampa
  • 4Department of Obstetrics and Gynecology, University of South Florida, Tampa
JAMA Pediatr. 2019;173(5):493-494. doi:10.1001/jamapediatrics.2019.0112

Cumulative evidence supports a causal association between tobacco use in pregnancy and intrauterine growth restriction,1,2 and a plausible association between smoking and low levels of maternal folic acid.3 Given this evidence, we conducted a double-blind, randomized clinical trial to determine the efficacy of higher-dose folic acid in preventing a reduction in fetal body size among infants of women who smoked tobacco cigarettes during pregnancy.

This randomized clinical trial was conducted from March 2011 to October 2015 at the Department of Obstetrics and Gynecology at the University of South Florida in Tampa. Eligibility criteria were (1) status as currently active smokers per self-report and cotinine biomarker; (2) an age between 18 and 44 years; (3) a gestation of less than 21 weeks at study entry; and (4) residency in Tampa, Florida. (The trial protocol is available in Supplement 1.) Data analyses took place from January 2017 to July 2018.