- Medication and Pregnancy KB

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Ishikawa (Controls unexposed, disease free), 2023	retrospective cohort (claims database)	A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. These claims include prescribed medications.	A large administrative claims database which contained all the inpatient and outpatient received from insurers (including diagnoses, surgical and medical procedures). The major malformations in claims were validated against patient medical records: the overall predictive positive value was 91.5%	No adjustment for this group of comparison. Exclusion of multiple deliveries and infants who had chromosomal abnormalities.
Ishikawa (Controls unexposed, sick), 2023	retrospective cohort (claims database)	A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. These claims include prescribed medications.	A large administrative claims database which contained all the inpatient and outpatient received from insurers (including diagnoses, surgical and medical procedures). The major malformations in claims were validated against patient medical records: the overall predictive positive value was 91.5%	No adjustment for this group of comparison. Exclusion of multiple deliveries and infants who had chromosomal abnormalities.
Mito, 2019	retrospective cohort	Data extracted from mothers’ electronic health records.	Clinical information, such as birth date, underlying disease, past medical history, previous pregnancy complications, family history, as well as information on the course of the index pregnancy and the newborn, were obtained from electronic medical records.	No adjustment. Singleton only. A subgroup analysis after excluding women with diabetes mellitus remained similar. No statistical difference for Body mass index, Diabetes mellitus, smoking and alcohol consumption during pregnancy.
Weber-Schoendorfer, 2008	prospective cohort	A similarly structured questionnaire was used by all the centres to record the following data at the first contact during (early) pregnancy before the pregnancy outcome was known, including details of drug exposure (timing in pregnancy, dose, and duration).	Follow-up was conducted by mailed questionnaire or by a telephone interview with the woman and/or her physician and/or the pediatrician of the infant. Pregnancy outcome, gestational age at birth, birth weight, birth defects and postnatal disorders were obtained.	No adjustment for this group of exposure.

master protocol