Clotrimazole - Medication and Pregnancy KB

Clotrimazole

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Daniel, 2018	Israel 2003 - 2009	All clinically apparent pregnancies to women 15-45 years of age registered with Clalit Health Services (CHS) maintenance organization who were admitted for birth or diagnosed with spontaneous abortion at Soroka Medical Center (SMC).	Dispensation of vaginal clotrimazole from the first day of the last menstrual period until the date of admission to the hospital for pregnancies that resulted in spontaneous abortion or until 20 weeks of pregnancy for pregnancies that ended with birth.	unexposed (general population or NOS) No dispensation of anti-mycotic medication (vaginal or oral).	2712 / 62137	Vaginal exposure.
Rotem, 2018	Israel 1999 - 2009	All women who gave birth or underwent a pregnancy termination at Soroka Medical Center, Beer-Sheva, Israel.	Women who were dispensed with clotrimazole vaginal tables during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnancies that were not exposed to either drug from the azoles family (e.g. vaginal, systemic or topical formulation).	1993 / 95781	Vaginal exposure

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Abdel-Salam, 2000	Hungary 1980 - 1996	Newborn infants (including infant deaths and usual stillborn fetuses) with isolated microcephaly.	Newborn infants (including infant deaths and usual stillborn fetuses) without congenital abnormalities.	109 / 218	Study design completed with other studies published on the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA).
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
Czeizel, 1999	Hungary 1980 - 1992	Infants (liveborn infants, stillborn infants, and electively aborted fetuses) with congenital abnormalities (CAs) were selected from the Hungarian Congenital Abnormality Registry.	Infants without congenital abnormalities, matched according to sex, birth week, and district of parents' residence selected from the national birth registry of the Central Statistical Office.	18515 / 32804	Overlapping: Abdel-Salam 2000, Vermes 2015 and Medveczky 2004 studied specifically 3 outcomes (Microcephaly; oesophagial atresia; neural tube defects) on the same database and a longer period (1980 - 1996) => these outcomes are not reported here.
Medveczky, 2004	Hungary 1980 - 1996	Newborn infants (including infant deaths and usual stillborn fetuses) with Neural tube defects with non-syndromic (i.e. isolated anencephaly, spina bifida aperta/cystica, encephalocele).	Newborn infants (including infant deaths and usual stillborn fetuses) without congenital abnormalities.	1202 / 38151	Study design completed with other studies published on the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). For metronidazole, data not reported because already included (Kazy 2005b; Czeizel 1998).
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
Vermes, 2015	Hungary 1980 - 1996	Newborn infants (including infant deaths and usual stillborn fetuses) with isolated Oesophageal Atresia.	Newborn infants (including infant deaths and usual stillborn fetuses) without congenital abnormalities.	221 / 356	Study design completed with other studies published on the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). Cases with multiple/syndromic OA were excluded from the study.
Zarante, 2009	Colombia 2001- 2006	All newborns and stillborns of weight >500 g that presented only one craniofacial malformation, not associated with any other congenital condition.	The next non-malformed same sex child born in the same hospital.	374 / 728

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