| Study | Country Study period Study design |
Data source | Exposure definition | Non-exposure definition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|
|
Daniel 2018 |
Israel 2003 - 2009 retrospective cohort (claims database) |
Soroka Medical Center, Clalit Health Services, Israel. | 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). |
1st trimester | 2712 / 62137 | Vaginal exposure. | |
| Medication dispensions during pregnancy were retrieved from the CHS medication database which contains all drug dispensions (prescription or OTC) to all patients insured by CHS in both community and hospital pharmacies. | ||||||||
|
Rotem 2018 |
Israel 1999 - 2009 retrospective cohort (claims database) |
Four computerised databases in the 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). |
1st trimester | 1993 / 95781 | Vaginal exposure | |
| Data for drugs dispensed during pregnancy were provided by the Clalit HMO medication database. | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Abdel-Salam 2000 |
Hungary 1980 - 1996 case control |
The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). | Newborn infants (including infant deaths and usual stillborn fetuses) with isolated microcephaly. | Newborn infants (including infant deaths and usual stillborn fetuses) without congenital abnormalities. | Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families. | during pregnancy (anytime or not specified) | 109 / 218 | Study design completed with other studies published on the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). | |
| The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office. | |||||||||
|
Carter 2008 |
USA 1997 - 2003 case control |
National Birth Defects Prevention Study (NBDPS), USA | 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. | Structured maternal interviews were conducted mainly by telephone in English or Spanish no later than 24 months after the expected date of delivery (EDD) to obtain data on maternal exposures during pregnancy. | 1st trimester | 12274 / 4774 | ||
| Cases and controls were identified by the birth defects surveillance systems in 10 states of USA. Medical records were obtained for all cases and reviewed by clinical geneticists. | |||||||||
|
Czeizel 1999 |
Hungary 1980 - 1992 case control |
The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). | 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. | The exposure data were obtained: (i) prospectively through antenatal care logbooks and other medical records; (ii) retrospectively by questionnaires completed by mothers; and (iii) by the help of regional nurses who visited and questioned all nonrespondent case and 200 control mothers. | 1st trimester, during pregnancy (anytime or not specified) | 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. | |
| The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory. Autopsy was obligatory for all infant deaths during the study period (1980-1992),and pathologists sent a copy of a detailed autopsy report to the Registry. | |||||||||
|
Medveczky 2004 |
Hungary 1980 - 1996 case control |
The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). | 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. | Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families. | 1st trimester | 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). | |
| The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office. | |||||||||
|
Rosa 1987 |
USA 1980 - 1983 case control |
COMPASS, a database generated by Health Information Designs from routinely computerized Medicaid invoices for prescriptions and diagnoses | 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. | Medicaid invoices for prescriptions. | 1st trimester, 3 months (or more) before pregnancy or during pregnancy | 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. | |
| Medicaid invoices for diagnoses. | |||||||||
|
Ross 2003 |
USA and Canada 1983 - 1988 case control |
The registration files of the former Children’s Cancer Group (CCG) and general population. | 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. | Exposure information was collected from mothers using a structured telephone questionnaire. All prescription drugs recorded in the medical record were abstracted, including data for the trimester of pregnancy the drug was prescribed based upon gestational ages recorded in medical records. | during pregnancy (anytime or not specified) | 243 / 393 | ||
| Signed medical record release forms were obtained and complete copies of medical records were requested. Data were abstracted from medical records by two registered nurses using a structured protocol. | |||||||||
|
Vermes 2015 |
Hungary 1980 - 1996 case control |
The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). | 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. | Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families. | 1st trimester, during pregnancy (anytime or not specified) | 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. | |
| The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office. | |||||||||
|
Zarante 2009 |
Colombia 2001- 2006 case control |
The Institute of Human Genetics of the Pontificia Universidad Javeriana, an active member of the Latin-American Collaborative Study of Congenital Malformations (ECLAMC) which is an international registry of congenital malformations . | 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. | Information collected in 10 Colombian hospitals (NOS). | during pregnancy (anytime or not specified) | 374 / 728 | ||
| Information collected in 10 Colombian hospitals (NOS). | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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