Temazepam

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Ban (Other indications) (Controls unexposed, disease free), 2014	retrospective cohort (claims database)	Exposure was obtained from The Health Improvement Network (THIN), where anonymised children’s and mothers’ medical records from 495 general practices throughout the UK were linked. Prescriptions are automatically entered.	All diagnostic recordings of major congenital anomalies (excluding genetic anomalies and anomalies attributed to known teratogens, e.g. anomalies due to maternal infections and fetal alcohol syndrome) are extracted from the children’s general practice records.	Singletons only. Exclusion of women with serious mental illness (i.e. bipolar disorder, schizophrenia and other related psychotic disorders) or with epilepsy diagnoses or with prescriptions of antiepileptic drugs in pregnancy. Adjusted for the year of the child’s birth, maternal age at childbirth, socioeconomic status, smoking and body mass index.
Ban (Other indications) (Controls unexposed, sick), 2014	retrospective cohort (claims database)	Exposure was obtained from The Health Improvement Network (THIN), where anonymised children’s and mothers’ medical records from 495 general practices throughout the UK were linked. Prescriptions are automatically entered.	All diagnostic recordings of major congenital anomalies (excluding genetic anomalies and anomalies attributed to known teratogens, e.g. anomalies due to maternal infections and fetal alcohol syndrome) are extracted from the children’s general practice records.	Singletons only. Exclusion of women with serious mental illness (i.e. bipolar disorder, schizophrenia and other related psychotic disorders) or with epilepsy diagnoses or with prescriptions of antiepileptic drugs in pregnancy. Adjusted for the year of the child’s birth, maternal age at childbirth, socioeconomic status, smoking and body mass index.
Bonnot, 2003	case control	The medical records are checked to obtain data on treatment intake and other exposures or risks.	After having defined a population, often on geographical criteria, these networks set up birth observatories in order to exhaustively identify neonatal malformations in their reference population.	Adjusted for age and parity.
Laspro, 2024	nested case control	Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy.	Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records.	None.
Sheehy, 2019	nested case control	The Quebec Public Prescription Drug Insurance Plan database (drug name, start date, dose, and duration).	The data sources included the medical service database the Régie de l’assurance maladie du Québec (diagnoses, medical procedures, ...) and the MedEcho database (in-hospital diagnoses and procedures, including gestational age for planned abortions, spontaneous abortions, and deliveries).	Adjusted for (1) maternal sociodemographic variables (2) maternal chronic conditions (hypertension, diabetes, depression/anxiety, alcohol ...), (3) health care resources utilization, (4) pregnancy-associated variables, (5) concomitant exposure to antidepressants and/or antipsychotics. Matched by gestational age and calendar year. Exclusion of women with epilepsy and exposed to known teratogens.

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