| 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 |
|---|
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
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. | |||||||||
|
Kerr 2018 |
USA and Canada 1993 - 2015 case control |
Slone Epidemiology Center Birth Defects Study (BDS). | Infants with microcephaly alone (“isolated”) and microcephaly that included other major birth defects (“non-isolated”). | Nonmalformed live-born infants. | Within 6 months of delivery, trained BDS nurse- interviewers contacted mothers to complete a roughly 1-hr computer-assisted telephone interview, including medications during pregnancy. | 1st trimester, 2nd trimester, 3rd trimester | 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. | |
| Cases and controls were ascertained at participating hospitals or birth defect registries in the same areas. | |||||||||
|
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. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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