Nitrazepam (Epilepsy) - Medication and Pregnancy KB

Nitrazepam (Epilepsy)

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
Thomas (Epilepsy) (Controls exposed to LTG) 2022	India 1998 - 2019 prospective cohort	The Kerala Registry of Epilepsy and Pregnancy (KREP), India.	Infants of women with epilepsy who were exposed to Nitrazepam monotherapy at anytime during the antenatal period.	exposed to other treatment, sick Infants of women with epilepsy who were exposed to Lamotrigine monotherapy at anytime during the antenatal period.	during pregnancy (anytime or not specified)	2 / 26	No use of delayed mental development, because discrepancy in LTG data '1/26 (11.5%)'.
Thomas (Epilepsy) (Controls exposed to LTG) 2022	India 1998 - 2019 prospective cohort		Each pregnant woman in the Kerala Registry of Epilepsy and Pregnancy (KREP) maintained a pregnancy diary to record the daily use of antiseizure medications (ASMs). Data were then transferred to the clinical records of the registry during their clinic visits.		during pregnancy (anytime or not specified)	2 / 26
Thomas (Epilepsy) (Controls unexposed, sick) 2022	India 1998 - 2019 prospective cohort	The Kerala Registry of Epilepsy and Pregnancy (KREP), India.	Infants of women with epilepsy who were exposed to Nitrazepam monotherapy at anytime during the antenatal period.	unexposed, sick Infants of women with epilepsy who were not exposed to any antiseizure medications (ASMs) during pregnancy.	during pregnancy (anytime or not specified)	2 / 110
Thomas (Epilepsy) (Controls unexposed, sick) 2022	India 1998 - 2019 prospective cohort		Each pregnant woman in the Kerala Registry of Epilepsy and Pregnancy (KREP) maintained a pregnancy diary to record the daily use of antiseizure medications (ASMs). Data were then transferred to the clinical records of the registry during their clinic visits.		during pregnancy (anytime or not specified)	2 / 110

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

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

Empty. There are no case-control studies available for this drug.

master protocol