Bromazepam - Medication and Pregnancy KB

Bromazepam

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

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

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 2003	France 1976 - 1997 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	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 2003	France 1976 - 1997 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
Kitchin 2022	Spain 2002 - 2015 case control	The Spanish database BIFAP (Base de Datos para la Investigacion Farmacoepidemiologica en Atencion Primaria, Database for Pharmacoepidemiological Research in Primary Care).	Pregnant woman suffering a miscarriage.	Pregnant woman randomly selected from the whole cohort among women who were still at risk within follow-up, by risk-set sampling and individually matched to cases.	Database for Pharmacoepidemiological Research in Primary Care, a computerized medical longitudinal population database of electronic medical records from 10.153 primary care practitioners and pediatricians distributed on nine Autonomous Regions (out of 17), which contains prescriptions.	1st trimester	18070 / 54209	Authors provided 2 exposure definitions: Use in both periods (continuers) and Use only during pregnancy (new users) => use of data for 'Use in both periods (continuers)', to decrease misclassification bais (exposure occurred before outcome).
Kitchin 2022	Spain 2002 - 2015 case control		Database for Pharmacoepidemiological Research in Primary Care, a computerized medical longitudinal population database of electronic medical records from 10.153 primary care practitioners and pediatricians, which contains medical diagnoses, medical visits, hospital admissions.			1st trimester	18070 / 54209
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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