Oxazepam (Psy and mixed indications)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Källén, 2013 Swedish
1996 - 2011
Nearly all births in Sweden during the study period (1,575,847) are registered in The Swedish Medical Birth 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.
843 / 1575847 Follow-up period known thanks to author's email reply.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Bonnot, 2001 France
1976 - 1998
Infants with the studied congenital malformation. Infants with a malformations other than this one studied. -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).
Cornel - The NNL registry, 1996 The Netherlands
1981 - 1994
Infants with a cleft lip with or without cleft palate. All infants notified with other anomalies. 277 / 3737
Sheehy, 2019 Canada
1998 - 2015
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. 27149 / 134305

master protocol