Nitrazepam (Psy and mixed indications)

Study Type of data Exposure measurement Outcome assessment Adjustment
Czeizel, 1987 case control 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. Cases were identified in the Hungarian Congenital Malformation Registry (HCMR) and controls were identified using the records of the obstetrical institutions. Three controls were matched to each index case by birth place, week of birth, sex, and outcome (stillbirth, infant death, or survivor).
Eros, 2002 case control 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. 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. Controls matched to every case according to sex, birth week in the year when the case was born, and district of parents’ residence. No adjustment for this group of exposure.
Källén, 2013 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). The Swedish Medical Birth Registry contain information based on standardized medical records from the first and further antenatal visit, the delivery and the paediatric examination. Supplemented with data from the Register of Birth Defects and Hospital Discharge Register. Adjustment was made for year of birth, maternal age (5-year class), parity, smoking in early pregnancy and body mass index.
Sheehy, 2019 nested case control The Quebec Public Prescription Drug Insurance Plan database (drug name, start date, dose, and duration). 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). No adjustment for this group of exposure. Matched by gestational age and calendar year. Exclusion of women with epilepsy and exposed to known teratogens.

master protocol