Study |
Type of data |
Exposure measurement |
Outcome assessment |
Adjustment |
Bracken, 1981
|
case control
|
Information concerning exposure to drugs were obtained using a standardized questionnaire given by trained interviewers (after delivery). All drugs used in each month of pregnancy were recorded and classified (physician also contacted for less than 10% of reported drugs).
|
The medical records of all potential cases as judged by initial hospital diagnosis were examined by an internist or pediatrician associated with the study. Attending physician were contacted when necessary to obtain more information.
|
None.
|
Czeizel, 2004
|
case control
|
Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; 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. Adjusted (no clear further details).
|
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).
|
Hartz, 1975
|
prospective cohort
|
A history of drug use covering the period of the pregnancy (and 1 month before) was obtained by interview of each woman, on entry into the study. Then it was also obtained at 4-week intervals during the pregnancy and confirmed by the attending physician or by review of the hospital or clinic record.
|
Children were examined at birth, four further examinations were performed before the fourth birthday and were then followed with further medical and psychologic examinations until the 8th birthday.
|
Factors incorporated with the multivariate analysis: maternal age, sex of child, birth weight, duration of pregnancy, single umbilical artery, hypertension during pregnancy, hemorrhagic and placental factors, hydramnios, maternal diabetes mellitus, hyperthyroidism, convulsive disorders (...) and history of congenital defects in 1st order relatives. Exclusion of multiple pregnancies and rubella.
|
Kullander, 1976
|
nested case control
|
Information on drug use was obtained mainly from the questionnaires administered to pregnant women, sometimes supplemented from hospital records etc. Information was usually collected before the outcome of the pregnancy was known. The (approximate) time of intake of each drug used was recorded.
|
All living children were carefully investigated by a pediatrician after birth and were followed to about 1 year old at the child health centres. Autopsy was performed and the age at death was recorded. The presence of major and minor malformations was recorded for all infants.
|
None.
|
Meng a (Controls unexposed, sibling), 2023
|
population based cohort retrospective
|
The National Health Insurance (NHI) database that comprises anonymised health insurance claims for visits, procedures, and prescriptions for more than 99% of the population in Taiwan (about 23 million).
|
The National Birth Certificate Application (BCA) database that includes notably gestational age at birth, birth date of newborns, singleton or multiple pregnancy, birthweight, and birth outcomes.
|
Siblings. Singletons only. Adjusted for maternal age, sex of the infant, birth year, psychiatric medical conditions, tobacco use, alcohol use, drug abuse, and obstetric comorbidity index scores.
|
Meng a (Controls unexposed, sick), 2023
|
population based cohort retrospective
|
The National Health Insurance (NHI) database that comprises anonymised health insurance claims for visits, procedures, and prescriptions for more than 99% of the population in Taiwan (about 23 million).
|
The National Birth Certificate Application (BCA) database that includes notably gestational age at birth, birth date of newborns, singleton or multiple pregnancy, birthweight, and birth outcomes.
|
Singletons only. Propensity score (PS-FSW) to control for maternal age and nationality, sex of the infant and year of birth, indications for use (eg, anxiety, insomnia, depression, schizophrenia, epilepsy, and bipolar disorder), lifestyle factors (obesity, tobacco, alcohol, ...), chronic maternal comorbidities (hypertension, diabetes, ...), medication use, obstetric comorbidity, health-care use.
|
Milkovich, 1974
|
retrospective cohort
|
For each gravida, the Studies have available data on all drugs prescribed not only in the prenatal clinical but in any Permanente or Kaiser medical-care facility, from the combined clinia and hospital medical record.
|
All the data analysez here are derived from physicians' notations in the mothers' medical records.
|
None.
|
Noh, 2022
|
population based cohort retrospective
|
The Health Insurance Review and Assessment Service (HIRA) database that comprises notably healthcare utilization (e.g., drug prescription and medical procedure).
|
Major congenital malformations were identified by diagnostic records, according to the ICD-10 codes defined by the European Surveillance of Congenital Anomalies classification.
|
Exclusion of exposures to known teratogens during 1st trimester. Adjusted for maternal age, type of insurance, maternal psychiatric conditions (e.g., bipolar disorder, depression/mood disorder, anxiety, and sleep disorder), maternal conditions (e.g., epilepsy, headache, diabetes, hypertension), parity, plurality, concomitant medications (e.g., antidepressants, ...), and healthcare utilization.
|
Rothman, 1979
|
case control
|
After each year of the study period, questionnaires were mailed to mothers of all control subjects and cases identified during that year. The questionnaire inquired notably about drugs prior to and during early pregnancy.
|
Cases were mainly from the roster of the New England Regional Infant Cardiac Program (NERICP), a service program designed to provide specialized care to all infants born in New England with serious congenital heart disease. Controls were selected randomly from the roster of all Massachusetts births.
|
The results presented by authors in the publication are from the unstratified data because the data were free of confounding by any of the factors examined (parity, maternal age, educational background and insulin use).
|
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.
|