Miconazole (all routes except local only)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Carter, 2008 USA
1997 - 2003
Cases with selected birth defects (included live births, stillbirths 20 weeks or longer or greater than 500 g, or elective terminations). Live births without birth defects that were randomly selected from birth certificates or birth hospitals in the geographic regions monitored by the state surveillance systems. 12274 / 4774
Kerr, 2018 USA and Canada
1993 - 2015
Infants with microcephaly alone (“isolated”) and microcephaly that included other major birth defects (“non-isolated”). Nonmalformed live-born infants. 166 / 12059 Authors analyzed separately “isolated” microcephaly and “non-isolated” microcephaly. Only isolated microcephaly are indexed in MetaPreg. Cases with chromosomal or syndrome diagnosis and potential congenital infections were excluded.
Rosa, 1987 USA
1980 - 1983
Patients aged zero to four years with suspected birth defect diagnoses, pregnancies ending in spontaneous abortions (ICD9 634-634.9). Deliveries not linked to birth defects. 6564 / 97775 Study on the efficacy of azole in an obstetrical indication, including the intrauterine deaths and/or late pregnancy and/or neonatal outcomes that are studied as efficacy criteria rather than safety one. => Not reported here.
Ross, 2003 USA and Canada
1983 - 1988
Children diagnosed with acute leukemia (i.e., acute myeloid leukemia, AML and acute lymphoblastic leukemia, ALL) in the first 18 months of life. Children without leukemia identified through random digit dialing. 243 / 393

master protocol