Study Type of data Exposure measurement Outcome assessment Adjustment
Dawson, 2014 case control Computer-assisted telephone interview which included detailed questions concerning exposures that occurred from 3 months prior to conception through the end of the pregnancy. Mothers were interviewed between 6 weeks and 24 months after their EDD. A clinical geneticist and a pediatrician trained in cardiology review the abstracted clinical records for each case infant. Clinical records for control infants were not available for review. None.
Howren, 2020 retrospective cohort PharmaNet captures complete information on all drug prescriptions dispensed including drug identification number, dispensation date, dispensation quantity, dosage, and duration. SGA was identified using ICD 9/10 codes in either the Medical Services Plan database (MSP), the Discharge Abstract Database (DAD), or in the BC Perinatal Database Registry (BCPDR) with data from obstetrical and neonatal medical records. Congenital anomalies were identified using the BCPDR. Multivariate model. Potential confounders considered: maternal and pregnancy characteristics (BMI, age, prior. adverse pregnancy outcome...), maternal comorbidities (anxiety, depression, diabetes), other medication use before pregnancy and during pregnancy, and healthcare utilisation (considered markers of disease severity and health status).
Matsui, 2003 retrospective cohort Patients with gestational trophoblastic tumor underwent chemotherapy at Chiba University Hospital. Major and minor congenital anomalies were detected. None.
Svirsky, 2017 retrospective cohort Medical records. Medical records. None.
Svirsky, 2009 retrospective cohort Computerized medical records and a telephone questionnaire when medical records were insufficients. After reviewing the medical records, the women were divided into two groups (less or more than 6 months). Computerized medical records and a telephone questionnaire when medical records were insufficients. None.
Weber-Schoendorfer (Controls exposed to other treatment, sick), 2014 prospective cohort Data on exposure were obtained via structured telephone interviews and/or mailed questionnaires completed by the mother and/or her physicians. Data on outcome were obtained via structured telephone interviews and/or mailed questionnaires completed by the mother and/or her physicians. Birth defects were classified as major or minor by 2 of the authors independently according to 2 standard classification systems. Matched for disease and year of enrollment. Propensity score adjustment including maternal age, alcohol consumption, smoking status, and parity as covariates. For analyses involving the disease-matched cohort, taking disease-modifying drugs or systemic glucocorticoids was additionally included in the propensity score estimation.
Weber-Schoendorfer (Controls unexposed, disease free), 2014 prospective cohort Data on exposure were obtained via structured telephone interviews and/or mailed questionnaires completed by the mother and/or her physicians. Data on outcome were obtained via structured telephone interviews and/or mailed questionnaires completed by the mother and/or her physicians. Birth defects were classified as major or minor by 2 of the authors independently according to 2 standard classification systems. Matched within the centers for year of ascertainment. Propensity score adjustment including maternal age, alcohol consumption, smoking status, and parity as covariates. For analyses involving the cohort of women without autoimmune diseases, taking disease-modifying antirheumatic drugs or systemic glucocorticoids was used as a covariate directly in addition to propensity score stratification.

master protocol