{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T21:45:12Z","timestamp":1788212712036,"version":"build-2803163510"},"reference-count":33,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,6,25]],"date-time":"2018-06-25T00:00:00Z","timestamp":1529884800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2018,11]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the risk for major malformations following first\u2010trimester exposure to vaginal azoles.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>A population\u2010based retrospective cohort study of women exposed to vaginal azoles from the first day of the last menstrual period until the 90th gestational day.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>A combination of four computerised databases: medications, birth, infant hospitalizations, and pregnancy terminations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Population<\/jats:title><jats:p>All women who gave birth or underwent a pregnancy termination at Soroka Medical Center, Beer\u2010Sheva, Israel, between 1999 and 2009.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Crude and adjusted relative risks for major congenital malformations and for specific malformations according to organ systems were calculated using a multivariate negative binomial regression. Potential confounders were assessed and controlled for included parity, maternal age, ethnicity, maternal diabetes, smoking, and year of birth or pregnancy termination. Additional analysis using propensity score matching was performed for selected malformations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>Major malformations as well as specific malformations according to organ systems.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 101 615 pregnancies, 1993 (1.96%) were exposed to clotrimazole vaginal tablets and 313 (0.31%) to miconazole vaginal tablets during the first trimester of pregnancy. No association was found between first\u2010trimester exposure to clotrimazole and major or specific malformations. An association was found between miconazole exposure and musculoskeletal malformation in general and other congenital musculoskeletal anomalies in particular. However, no association was detected when propensity score matching was used.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Intrauterine exposure to vaginal azoles during the first trimester of pregnancy was not associated with either major or specific malformations according to organ systems.<\/jats:p><\/jats:sec><jats:sec><jats:title>Tweetable abstract<\/jats:title><jats:p>First\u2010trimester exposure to vaginal azoles is not associated with either major or specific malformations.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1471-0528.15293","type":"journal-article","created":{"date-parts":[[2018,5,23]],"date-time":"2018-05-23T04:10:06Z","timestamp":1527048606000},"page":"1550-1556","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Risk of major congenital malformations following first\u2010trimester exposure to vaginal azoles used for treating vulvovaginal candidiasis: a population\u2010based retrospective cohort study"],"prefix":"10.1111","volume":"125","author":[{"given":"R","family":"Rotem","sequence":"first","affiliation":[{"name":"Department of Public Health Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"},{"name":"Faculty of Health Sciences Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B","family":"Fishman","sequence":"additional","affiliation":[{"name":"Department of Public Health Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"},{"name":"Faculty of Health Sciences Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Daniel","sequence":"additional","affiliation":[{"name":"Department of Public Health Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"},{"name":"Faculty of Health Sciences Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"},{"name":"Clalit Health Services Southern District Beer\u2010Sheva Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G","family":"Koren","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"},{"name":"Maccabi Health Services Tel Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Lunenfeld","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"},{"name":"Clalit Health Services Southern District Beer\u2010Sheva Israel"},{"name":"Department of Obstetrics and Gynecology Soroka Medical Center Beer\u2010Sheva Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Levy","sequence":"additional","affiliation":[{"name":"Department of Public Health Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"},{"name":"Faculty of Health Sciences Ben\u2010Gurion University of the Negev Beer\u2010Sheva Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,6,25]]},"reference":[{"key":"e_1_2_6_2_1","first-page":"1","article-title":"Sexually transmitted diseases treatment guidelines, 2015","volume":"64","author":"Workowski KA","year":"2015","journal-title":"MMWR Recomm Rep"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jss.2005.05.019"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkn157"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2007.08.044"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1301066"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2015.11.022"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2004.02.011"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1741-4520.2004.00007.x"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-3016.1999.00157.x"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1086\/514977"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.toxlet.2010.07.005"},{"key":"e_1_2_6_13_1","first-page":"751","article-title":"Pregnancy outcomes after first\u2010trimester vaginitis drug therapy","volume":"96","author":"Roza FW","year":"1987","journal-title":"Decision Epidemiol Surveillance, FDA"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1592\/phco.19.3.221.30919"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/00001648-199907000-00016"},{"key":"e_1_2_6_16_1","unstructured":"AngelD.www.cbs.gov.il\/hodaot2007n\/01_07_215b.pdf. 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