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

Nitrazepam (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 nitrazepam 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	134 / 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	134 / 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
Czeizel 1987	Hungary 1970 - 1976 case control	The Hungarian Congenital Malformation Registry (HCMR).	Infants born with facial clefting born during the study period.	Infants born witout facial clefting born during the study period.	A reply-paid postal questionnaire was sent to all parents notably concerning the drugs taken (with a printed list of drugs to be red before filling in the questionnaire). The prenatal care booklet of the pregnancies and all medical documents were also studied.	1st trimester, during pregnancy (anytime or not specified)	1201 / 1201	Use of Retrospective case control study. There were 630 cases with isolated cleft lip and/or cleft palate, 179 cases with isolated cleft palate, and 392 cases of multiple congenital anomalies including cleft lip and/or cleft palate.
Czeizel 1987	Hungary 1970 - 1976 case control	The Hungarian Congenital Malformation Registry (HCMR).	Cases were identified in the Hungarian Congenital Malformation Registry (HCMR) and controls were identified using the records of the obstetrical institutions.			1st trimester, during pregnancy (anytime or not specified)	1201 / 1201
Eros 2002	Hungary 1980 - 1996 case control	The Hungarian Case–Control Surveillance of Congenital Abnormalities (HCCSCA).	Newborn infants with isolated congenital abnormality (CA) and multiple CA. Exclusions of some mild congenital abnormalities and minor congenital abnormality (methods in Czeizel 1999).	Two or three newborn infants without congenital anomalies matched to every case according to sex, birth week in the year when the case was born, and district of parents’ residence from the National Birth Registry of the Central Statistical Office.	Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents immediately after the selection of cases/controls; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families.	during pregnancy (anytime or not specified)	22865 / 38151
Eros 2002	Hungary 1980 - 1996 case control		The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office.			during pregnancy (anytime or not specified)	22865 / 38151
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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