Fluconazole use and birth defects in the National Birth Defects Prevention Study

National Birth Defects Prevention Study

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background Low-dose fluconazole is used commonly to treat vulvovaginal candidiasis, a condition occurring frequently during pregnancy. Conflicting information exists on the association between low-dose fluconazole use among pregnant women and the risk of major birth defects. Objective We used data from the National Birth Defects Prevention Study to examine this association. Study Design The National Birth Defects Prevention Study is a multisite, population-based, case-control study that includes pregnancies with estimated delivery dates from 1997 to 2011. Information on fluconazole use in early pregnancy was collected by self-report from 31,645 mothers of birth defect cases and 11,612 mothers of unaffected controls. Adjusted odds ratios and 95% confidence intervals were estimated for birth defects with 5 or more exposed cases; crude odds ratios and exact 95% confidence intervals were estimated for birth defects with 3-4 exposed cases. Results Of the 43,257 mothers analyzed, 44 case mothers and 6 control mothers reported using fluconazole. Six exposed infants had cleft lip with cleft palate, 4 had an atrial septal defect, and each of the following defects had 3 exposed cases: hypospadias, tetralogy of Fallot, d-transposition of the great arteries, and pulmonary valve stenosis. Fluconazole use was associated with cleft lip with cleft palate (odds ratio = 5.53; confidence interval = 1.68-18.24) and d-transposition of the great arteries (odds ratio = 7.56; confidence interval = 1.22-35.45). Conclusions The associations between fluconazole and both cleft lip with cleft palate and d-transposition of the great arteries are consistent with earlier published case reports but not recent epidemiologic studies. Despite the larger sample size of the National Birth Defects Prevention Study, fluconazole use was rare. Further investigation is needed in large studies, with particular emphasis on oral clefts and conotruncal heart defects.

Original languageEnglish (US)
Pages (from-to)657e1-657e9
JournalAmerican Journal of Obstetrics and Gynecology
Volume214
Issue number5
DOIs
StatePublished - May 1 2016
Externally publishedYes

Fingerprint

Fluconazole
Transposition of Great Vessels
Mothers
Cleft Lip
Cleft Palate
Odds Ratio
Confidence Intervals
Pregnancy
Vulvovaginal Candidiasis
Hypospadias
Pulmonary Valve Stenosis
Tetralogy of Fallot
Sample Size
Self Report
Case-Control Studies
Pregnant Women
Epidemiologic Studies
Population

Keywords

  • birth defect
  • congenital malformation
  • fluconazole

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Fluconazole use and birth defects in the National Birth Defects Prevention Study. / National Birth Defects Prevention Study.

In: American Journal of Obstetrics and Gynecology, Vol. 214, No. 5, 01.05.2016, p. 657e1-657e9.

Research output: Contribution to journalArticle

National Birth Defects Prevention Study. / Fluconazole use and birth defects in the National Birth Defects Prevention Study. In: American Journal of Obstetrics and Gynecology. 2016 ; Vol. 214, No. 5. pp. 657e1-657e9.
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abstract = "Background Low-dose fluconazole is used commonly to treat vulvovaginal candidiasis, a condition occurring frequently during pregnancy. Conflicting information exists on the association between low-dose fluconazole use among pregnant women and the risk of major birth defects. Objective We used data from the National Birth Defects Prevention Study to examine this association. Study Design The National Birth Defects Prevention Study is a multisite, population-based, case-control study that includes pregnancies with estimated delivery dates from 1997 to 2011. Information on fluconazole use in early pregnancy was collected by self-report from 31,645 mothers of birth defect cases and 11,612 mothers of unaffected controls. Adjusted odds ratios and 95{\%} confidence intervals were estimated for birth defects with 5 or more exposed cases; crude odds ratios and exact 95{\%} confidence intervals were estimated for birth defects with 3-4 exposed cases. Results Of the 43,257 mothers analyzed, 44 case mothers and 6 control mothers reported using fluconazole. Six exposed infants had cleft lip with cleft palate, 4 had an atrial septal defect, and each of the following defects had 3 exposed cases: hypospadias, tetralogy of Fallot, d-transposition of the great arteries, and pulmonary valve stenosis. Fluconazole use was associated with cleft lip with cleft palate (odds ratio = 5.53; confidence interval = 1.68-18.24) and d-transposition of the great arteries (odds ratio = 7.56; confidence interval = 1.22-35.45). Conclusions The associations between fluconazole and both cleft lip with cleft palate and d-transposition of the great arteries are consistent with earlier published case reports but not recent epidemiologic studies. Despite the larger sample size of the National Birth Defects Prevention Study, fluconazole use was rare. Further investigation is needed in large studies, with particular emphasis on oral clefts and conotruncal heart defects.",
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AB - Background Low-dose fluconazole is used commonly to treat vulvovaginal candidiasis, a condition occurring frequently during pregnancy. Conflicting information exists on the association between low-dose fluconazole use among pregnant women and the risk of major birth defects. Objective We used data from the National Birth Defects Prevention Study to examine this association. Study Design The National Birth Defects Prevention Study is a multisite, population-based, case-control study that includes pregnancies with estimated delivery dates from 1997 to 2011. Information on fluconazole use in early pregnancy was collected by self-report from 31,645 mothers of birth defect cases and 11,612 mothers of unaffected controls. Adjusted odds ratios and 95% confidence intervals were estimated for birth defects with 5 or more exposed cases; crude odds ratios and exact 95% confidence intervals were estimated for birth defects with 3-4 exposed cases. Results Of the 43,257 mothers analyzed, 44 case mothers and 6 control mothers reported using fluconazole. Six exposed infants had cleft lip with cleft palate, 4 had an atrial septal defect, and each of the following defects had 3 exposed cases: hypospadias, tetralogy of Fallot, d-transposition of the great arteries, and pulmonary valve stenosis. Fluconazole use was associated with cleft lip with cleft palate (odds ratio = 5.53; confidence interval = 1.68-18.24) and d-transposition of the great arteries (odds ratio = 7.56; confidence interval = 1.22-35.45). Conclusions The associations between fluconazole and both cleft lip with cleft palate and d-transposition of the great arteries are consistent with earlier published case reports but not recent epidemiologic studies. Despite the larger sample size of the National Birth Defects Prevention Study, fluconazole use was rare. Further investigation is needed in large studies, with particular emphasis on oral clefts and conotruncal heart defects.

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