Oxazepam (Psy and mixed indications) - Medication and Pregnancy KB

Oxazepam (Psy and mixed indications)

Exposed non-exposed, cohort studies

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
Källén 2013	Swedish 1996 - 2011 population based cohort retrospective	The Swedish Medical Birth Register, the Swedish Register of Prescribed Drugs, the Register of Birth Defect and Hospital Discharge Register.	Infants whose mothers used oxazepam in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy.	early pregnancy	843 / 1575847	Follow-up period known thanks to author's email reply.
Källén 2013	Swedish 1996 - 2011 population based cohort retrospective		At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006).		early pregnancy	843 / 1575847	Follow-up period known thanks to author's email reply.

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Bonnot 2001	France 1976 - 1998 case control	European Institut of Genomutations (IEG), Lyon, France.	Infants with the studied congenital malformation.	Infants with a malformations other than this one studied.	The medical records are checked to obtain data on treatment intake and other exposures or risks.	1st trimester	-9 / -9	Data completed with Bonnot 2003. Total number of infants with a congenital malformation is 13703, but the number of cases changes according to the studied malformations. Raw data not sufficient to calculate OR (data for 'control' groups not available).
Bonnot 2001	France 1976 - 1998 case control	European Institut of Genomutations (IEG), Lyon, France.	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.			1st trimester	-9 / -9
Cornel - The NNL registry 1996	The Netherlands 1981 - 1994 case control	The Northern Netherlands (NNL) registry, member of the EUropean Registration Of Congenital Anomalies (EUROCAT).	Infants with a cleft lip with or without cleft palate.	All infants notified with other anomalies.	The registry personnel actively collect information by going through hospital records. Data were supplied by pediatricians, obstetricians, midwives, general practitioners (GP's), clinical geneticists, and several other medical specialists. The data include on maternal drug use during pregnancy.	1st trimester	277 / 3737
Cornel - The NNL registry 1996	The Netherlands 1981 - 1994 case control		The registry personnel actively collect information by going through hospital records. Data were supplied by pediatricians, obstetricians, midwives, general practitioners (GP's), clinical geneticists, and several other medical specialists. The data include diagnostic information.			1st trimester	277 / 3737
Sheehy 2019	Canada 1998 - 2015 nested case control	A nested case-control study within the Quebec Pregnancy Cohort, Montreal, Quebec, Canada.	Pregnancies ending with spontaneous abortion (pregnancy loss between between the beginning of the sixth week of gestation and the 19th completed week of gestation, excluding planned or induced abortions).	Pregnancies ending with live births (5 for each case) randomly selected at the index date and matched with the case pregnancy by gestational age and calendar year.	The Quebec Public Prescription Drug Insurance Plan database (drug name, start date, dose, and duration).	early pregnancy	27149 / 134305
Sheehy 2019	Canada 1998 - 2015 nested case control		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).			early pregnancy	27149 / 134305

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

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