Antimycotic Azoles (all routes except local only)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Rosa - Miconazole, 1987 Mastroiacovo - Fluconazole, 1996 Sorensen - Fluconazole, 1999 Jick - Fluconazole and Itraconazole (Oral), 1999 Bar-Oz - Itraconazole, 2000 Kazy - Ketoconazole, 2005 De Santis - Itraconazole, 2009 Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 Berard - Fluconazole, 2019 Zhu - Fluconazole, 2020 111.03[0.99; 1.08]179,41949,549low Major congenital malformations Mastroiacovo - Fluconazole, 1996 Jick - Fluconazole and Itraconazole (Oral), 1999 Bar-Oz - Itraconazole, 2000 Kazy - Ketoconazole, 2005 De Santis - Itraconazole, 2009 Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 Berard - Fluconazole, 2019 81.11[0.99; 1.24]99,4239,544not evaluable Congenital heart defects Jick - Fluconazole and Itraconazole (Oral), 1999 Kazy - Ketoconazole, 2005 Carter - Miconazole, 2008 Molgaard-Nielsen - Fluconazole, 2013 Zhu - Fluconazole, 2020 51.04[0.81; 1.34]35,01645,382not evaluable Cleft lip with or without cleft palate Carter - Miconazole, 2008 Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 41.27[0.80; 2.00]6,11145,061not evaluable Limb defects Jick - Fluconazole and Itraconazole (Oral), 1999 Molgaard-Nielsen - Fluconazole, 2013 Berard - Fluconazole, 2019 Zhu - Fluconazole, 2020 40.99[0.87; 1.12]22,51346,635not evaluable Cleft palate Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 30.86[0.57; 1.29]3,30945,007not evaluable Craniosynostosis Carter - Miconazole, 2008 Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 30.94[0.48; 1.82]2,7677,400not evaluable Diaphragmatic hernia Carter - Miconazole, 2008 Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 31.64[0.67; 4.04]1,3537,401not evaluable Tetralogy of Fallot Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 32.18[0.93; 5.13]2,27345,009not evaluable Ventricular septal defect Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 31.08[0.90; 1.29]13,34845,008not evaluable Ano-rectal atresia and stenosis Carter - Miconazole, 2008 Howley - Fluconazole, 2016 22.27[0.88; 5.88]1,28650not evaluable Atrial septal defect Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 21.12[0.43; 2.87]7,66537,658not evaluable Atrioventricular septal defect Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 21.57[0.28; 8.69]84537,655not evaluable Ear malformations Molgaard-Nielsen - Fluconazole, 2013 Zhu - Fluconazole, 2020 21.08[0.24; 4.90]42745,000not evaluable Eye defects Berard - Fluconazole, 2019 Zhu - Fluconazole, 2020 21.01[0.64; 1.59]1,56238,961not evaluable Gastroschisis Carter - Miconazole, 2008 Howley - Fluconazole, 2016 20.37[0.07; 1.91]1,86746not evaluable Genital anomalies Berard - Fluconazole, 2019 Zhu - Fluconazole, 2020 21.31[0.71; 2.39]10,04938,961not evaluable Hypoplastic left heart (HLH/HLHS) Molgaard-Nielsen - Fluconazole, 2013 Howley - Fluconazole, 2016 22.21[0.81; 6.02]8477,359not evaluable Hypospadias Carter - Miconazole, 2008 Howley - Fluconazole, 2016 20.66[0.25; 1.78]3,33550not evaluable Nervous system anomalies Berard - Fluconazole, 2019 Zhu - Fluconazole, 2020 21.14[0.93; 1.39]5,18338,961not evaluable Oro-facial clefts Jick - Fluconazole and Itraconazole (Oral), 1999 Zhu - Fluconazole, 2020 20.84[0.60; 1.16]2,12837,970not evaluable Polydactyly Jick - Fluconazole and Itraconazole (Oral), 1999 Molgaard-Nielsen - Fluconazole, 2013 21.05[0.47; 2.38]6037,674not evaluable Single ventricle Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 21.44[0.47; 4.35]42537,654not evaluable Spina bifida Jick - Fluconazole and Itraconazole (Oral), 1999 Howley - Fluconazole, 2016 22.87[0.76; 10.88]1,280330not evaluable Total anomalous pulm venous return Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 20.83[0.28; 2.43]73737,654not evaluable Transposition of the great vessels Howley - Fluconazole, 2016 Zhu - Fluconazole, 2020 22.56[0.46; 14.10]1,53237,657not evaluable Urinary malformations Berard - Fluconazole, 2019 Zhu - Fluconazole, 2020 20.99[0.68; 1.45]8,39238,961not evaluable Anophthalmos/micropthalmos Howley - Fluconazole, 2016 14.54[0.25; 82.31]2326not evaluable Anotia Howley - Fluconazole, 2016 12.80[0.34; 23.32]6917not evaluable Aortic valve atresia/stenosis Howley - Fluconazole, 2016 12.05[0.11; 37.21]5136not evaluable Arhinencephaly/holoprosencephaly Howley - Fluconazole, 2016 16.08[0.33; 110.40]1736not evaluable Atresia of bile ducts Howley - Fluconazole, 2016 15.29[0.29; 95.97]1996not evaluable Atresia or stenosis of other parts of small intestine Howley - Fluconazole, 2016 12.21[0.12; 40.02]4776not evaluable Bilateral renal agenesis including Potter syndrome Howley - Fluconazole, 2016 15.54[0.31; 100.52]1906not evaluable Bladder exstrophy and/or epispadia Howley - Fluconazole, 2016 114.16[0.78; 258.42]746not evaluable Cardiac septal defects Berard - Fluconazole, 2019 11.33[0.84; 2.11]3,2821,313not evaluable Choanal atresia Howley - Fluconazole, 2016 16.34[0.35; 115.06]1666not evaluable Coarctation of aorta Howley - Fluconazole, 2016 13.31[0.67; 16.42]1,1718not evaluable Common arterial truncus Howley - Fluconazole, 2016 128.45[5.69; 142.20]1388not evaluable Congenital cataract Howley - Fluconazole, 2016 15.05[0.61; 42.05]3847not evaluable Congenital constriction bands/amniotic band Howley - Fluconazole, 2016 15.81[0.70; 48.39]3347not evaluable Congenital glaucoma Howley - Fluconazole, 2016 15.66[0.31; 102.68]1866not evaluable Digestive system anomalies Berard - Fluconazole, 2019 11.13[0.37; 3.47]6251,313not evaluable Double outlet right ventricle Howley - Fluconazole, 2016 110.13[1.21; 84.53]1927not evaluable Duodenal atresia or stenosis Howley - Fluconazole, 2016 14.44[0.24; 80.57]2376not evaluable Ebstein's anomaly Howley - Fluconazole, 2016 15.85[0.32; 106.11]1806not evaluable Encephalocele Howley - Fluconazole, 2016 14.64[0.26; 84.12]2276not evaluable Hydrocephaly Howley - Fluconazole, 2016 13.73[0.45; 31.08]5197not evaluable Limb reduction defects (LRD) Molgaard-Nielsen - Fluconazole, 2013 10.71[0.23; 2.20]5567,352not evaluable Microcephaly / Small head circumference for gestational age Kerr - Miconazole, 2018 10.96[0.06; 16.12]57216not evaluable Neural Tube Defects Carter - Miconazole, 2008 11.64[0.82; 3.30]75049not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Howley - Fluconazole, 2016 15.13[1.03; 25.46]7568not evaluable Omphalocele Howley - Fluconazole, 2016 12.40[0.13; 43.48]4396not evaluable Patent ductus arterious Zhu - Fluconazole, 2020 10.86[0.63; 1.18]2,29137,648not evaluable Pulmonary artery stenosis Molgaard-Nielsen - Fluconazole, 2013 126.34[1.26; 548.75]27,352not evaluable Pulmonary valve stenosis Howley - Fluconazole, 2016 13.59[0.67; 19.33]1,5569not evaluable Respiratory system anomalies Zhu - Fluconazole, 2020 11.01[0.84; 1.22]5,67037,648not evaluable Situs inversus Howley - Fluconazole, 2016 15.62[0.68; 46.84]3457not evaluable Syndactyly Molgaard-Nielsen - Fluconazole, 2013 10.38[0.10; 1.49]6817,352not evaluable Tricuspid atresia and stenosis Howley - Fluconazole, 2016 110.87[1.30; 90.74]1797not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Mastroiacovo - Fluconazole, 1996 Bar-Oz - Itraconazole, 2000 Norgaard - Fluconazole, 2008 De Santis - Itraconazole, 2009 41.19[0.78; 1.80]421,529not evaluable Low birth weight (< 2500g) Mastroiacovo - Fluconazole, 1996 Norgaard - Fluconazole, 2008 De Santis - Itraconazole, 2009 31.03[0.71; 1.48]51,400not evaluable Macrosomia (> 4000g) De Santis - Itraconazole, 2009 11.69[0.63; 4.55]17152not evaluable Small for gestational age (weight) Santos - Fluconazole, 2011 11.34[0.85; 2.12]8,192120not evaluable Maternal consequences Caesarean 0----- Neonatal disorders Neonatal disorders (as a whole) Bar-Oz - Itraconazole, 2000 De Santis - Itraconazole, 2009 20.80[0.57; 1.11]66319not evaluable Low Apgar score (< 7) (at 1 min) 0----- Low Apgar score (< 7) (at 5 min) 0----- Neonatal death (< 28 days of life) Pasternak - Fluconazole, 2018 10.73[0.42; 1.28]19010,640not evaluable Persistent pulmonary hypertension 0----- Very low Apgar score (< 5) (at 1 min) 0----- Very low Apgar score (< 5) (at 5 min) 0----- Long term consequences Leukemia Ross - Miconazole, 2003 10.94[0.53; 1.66]24361not evaluable Intrauterine deaths Late intrauterine deaths (> 22 weeks) Mastroiacovo - Fluconazole, 1996 Bar-Oz - Itraconazole, 2000 De Santis - Itraconazole, 2009 Molgaard-Nielsen - Fluconazole (Oral) (Controls unexposed, NOS), 2016 Pasternak - Fluconazole, 2018 Berard - Fluconazole, 2019 60.93[0.70; 1.23]1,23616,677not evaluable Early intrauterine death (< 22 weeks) Mastroiacovo - Fluconazole, 1996 Bar-Oz - Itraconazole, 2000 De Santis - Itraconazole, 2009 Molgaard-Nielsen - Fluconazole (Oral) (Controls unexposed, NOS), 2016 Berard - Fluconazole, 2019 52.01[1.34; 3.00]30,2906,538not evaluable Elective/induced termination of pregnancy Mastroiacovo - Fluconazole, 1996 Bar-Oz - Itraconazole, 2000 De Santis - Itraconazole, 2009 34.52[2.31; 8.84]80631not evaluable Intrauterine deaths (as a whole or unspecified) Bar-Oz - Itraconazole, 2000 11.75[1.47; 2.09]54199not evaluable Therapeutic terminations of pregnancy Inman - Fluconazole, 1994 11.37[0.64; 2.96]3860not evaluable0.0100.01.0

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