- Medication and Pregnancy KB

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Choi a, 2023	retrospective cohort (claims database)	Prescription database.	The presence of congenital malformations was identified via infants’ records and major malformations and their subtypes were defined based on the European Surveillance of Congenital Anomalies (EUROCAT) classification system (minor defects were excluded according to the EUROCAT exclusion list).	Propensity score: maternal age, income level, parity, multiple gestations, indications for PPIs (GERD, duodenitis...), maternal conditions (eg, anxiety, diabetes, and epilepsy), medication use (eg, opioid, NSAIDs), obstetric comorbidity index, and measures of health care use. Exclusion of exposures with known or potential teratogens. Sensitivity analyses: indications, singleton only, BMI, smoking.
Choi b, 2023	retrospective cohort (claims database)	Prescription database.	The National Health Insurance Service (NHIS) database.	Propensity score: maternal age, medical aid, income level, parity, multiple gestations, indications for PPIs (GERD, duodenitis...), maternal conditions (eg, anxiety, diabetes, and epilepsy), other medication prescription, obstetric comorbidity index, and measures of health care use. Sensitivity analyses: indications, singleton only, body mass index, smoking, sibling design, first-time pregnancy.
Diav-Citrin, 2005	prospective cohort	Details of exposure were collected during pregnancy before pregnancy outcome was known, using a structured questionnaire.	After the expected date of delivery, follow-up was conducted with the woman, her physician or midwife by a telephone interview and/or mailed questionnaire to obtain details on the pregnancy outcome.	None.
Fejzo, 2015	case control	Participants were asked to submit their medical records and complete an online survey regarding treatment.	Participants were asked to submit their medical records and complete an online survey regarding outcomes. A follow-up survey was administered on the diagnosis of childhood emotional, behavioral, and learning disorders.	Cases and controls were well-matched for mean maternal age, spontaneous labor, delivery method, and use of assisted reproduction. Children of cases and controls were well-matched for gender and age, with the average age between 8 and 9 years old.
Fejzo, 2013	case control	Participants were asked to submit their medical records and complete an online survey regarding treatment. The majority of participants, both cases and controls, joined the study and began the survey during their pregnancies.	Participants were asked to submit their medical records and complete an online surveyregarding outcomes. The majority of participants, both cases and controls, were automatically prompted to complete the survey on outcome following their due date.	None.
Källèn, 1998	population based cohort retrospective	At the first visit to the antenatal clinic (usually during weeks 10-12), the pregnant woman is interviewed by a midwife on drugs taken after the time the woman became pregnant and before the antenatal visit.	Malformations which has been reported to the Medical Birth Registry completed by the data of the Registry of Congenital Malformation and the Child Cardiology Register.	Stratification was made for year of birth (1997 births were compared with 1996 population as no final population data for 1997 were available), maternal age, parity and smoking habits in early pregnancy.
Lind, 2013	case control	The National Birth Defects Prevention Study uses computer-assisted telephone interviews to collect information from women 6 weeks to 24 months after their estimated date of delivery.	Cases are identified through population-based birth defects surveillance from each states. A clinical geneticist classifies eligible cases of hypospadias as isolated.	Adjusted for maternal age, race/ethnicity, education, pre-pregnancy BMI, previous live births, sub-fertility, study site, and year of due date.
Matok, 2012	retrospective cohort (claims database)	Electronic database of medications dispensed by ‘‘Clalit’’ pharmacies.	Two electronic databases of SMC (Soroka Medical Center) comprising one with clinical information from the Department of Obstetrics and Gynecology, and one with demographic and hospitalization data, and an SMC registry of medical pregnancy terminations with information collected manually.	Maternal age, parity, self-reported smoking status during pregnancy, maternal diabetes mellitus, year of birth, and population group (i.e., Jewish or Bedouin Muslim). Peripartum fever (deﬁned as a temperature of 38°C or higher) and pregnancy duration in days were added to the covariates for pregnancy outcomes other than congenital malformations.
Pasternak, 2010	population based cohort retrospective	The Prescription Drug Register provided information on all lansoprazole prescriptions filled by women in the cohort between 4 weeks before conception and delivery. (Omeprazole and Lansoprazole became OTC in 2006 and 2007 respectively).	Cases of birth defects were identified with the use of the National Patient Register and a random sample had a medical records review. Major birth defects were defined according to the EUROCAT classification.	No potential confounder stood out as an important one, therefore, as an alternative all potential confounders and their effect were sum up into one variable: the propensity score.
Yitshak-Sade, 2016	retrospective cohort (registry)	“Clalit” and Soroka Medical Center databases were encoded and linked to create a single registry of medications dispensed to children, and to their mothers before and during pregnancy.	The Soroka Medical Center Admission-Transfer-Discharge computerized database includes medical diagnoses from the hospital medical records. Children were deﬁned as asthmatic if they were hospitalized with asthma or recurrent wheezing between the ages of 2 and 13 years and with asthma medications.	Maternal allergies and asthma, maternal age, infertility treatment, lack of prenatal care, gestational age at delivery, cesarean section delivery, birth weight and sex, birth year, dispensing PPIs for children aged 0 to 2 years of age, and maternal use of the following medications during the exposure period: antibiotics, NSAI drugs, metoclopramide, and insulin.

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