- Medication and Pregnancy KB

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Boskovic (control unexposed, disease free), 2005	prospective cohort	During the initial contact, pregnancy information was collected. This included general information regarding maternal health and any possible xenobiotic exposure, including drug therapy. All xenobiotic exposures throughout gestation were also recorded after delivery.	A follow-up interview was conducted in women who were asked to provide information regarding pregnancy outcomes. The information obtained from the mother was verified by the child’s pediatrician or family physician, who were requested to complete a questionnaire on child health.	None
Boskovic (control unexposed, sick), 2005	prospective cohort	During the initial contact, pregnancy information was collected. This included general information regarding maternal health and any possible xenobiotic exposure, including drug therapy. All xenobiotic exposures throughout gestation were also recorded after delivery.	A follow-up interview was conducted in women who were asked to provide information regarding pregnancy outcomes. The information obtained from the mother was verified by the child’s pediatrician or family physician, who were requested to complete a questionnaire on child health.	None
Colvin - IFN beta1b, 2010	retrospective cohort (claims database)	The national Pharmaceutical Benefits Scheme, with around 80% of prescriptions dispensed in Australia.	Health administrative data from the WA Hospital Morbidity Data System, the Midwives’ Notification System, the WA Registry of Births and Deaths and the Birth Defect Registry of WA, enabling pregnancies and pregnancy outcomes to be ascertained.	None
Finkelsztejn (control exposed to Glatiramer), 2011	retrospective cohort	Data were obtained from medical records of patients attending regular consultations with their neurologists.	Data were obtained from medical records of patients attending regular consultations with their neurologists.	None
Finkelsztejn (control unexposed, sick), 2011	retrospective cohort	Data were obtained from medical records of patients attending regular consultations with their neurologists.	Data were obtained from medical records of patients attending regular consultations with their neurologists.	None
Fragoso a (control exposed to Glatiramer), 2013	retrospective cohort	Data were obtained from the medical records of patients attending regular consultations with their neurologists.	Data were obtained from the medical records of patients attending regular consultations with their neurologists.	None
Fragoso a (control unexposed, sick), 2013	retrospective cohort	Data were obtained from the medical records of patients attending regular consultations with their neurologists.	Data were obtained from the medical records of patients attending regular consultations with their neurologists.	None
Fragoso b (control exposed to Glatiramer), 2013	retrospective cohort	Data collection was retrospective, using patients’ medical records. Whenever data were missing from the medical records, the physician in charge of the case contacted the patient in order to obtain missing details. Only patients actually seen by the authors of this study were included.	Data collection was retrospective, using patients’ medical records. Whenever data were missing from the medical records, the physician in charge of the case contacted the patient in order to obtain missing details. Only patients actually seen by the authors of this study were included.	None
Fragoso b (control unexposed, sick), 2013	retrospective cohort	Data collection was retrospective, using patients’ medical records. Whenever data were missing from the medical records, the physician in charge of the case contacted the patient in order to obtain missing details. Only patients actually seen by the authors of this study were included.	Data collection was retrospective, using patients’ medical records. Whenever data were missing from the medical records, the physician in charge of the case contacted the patient in order to obtain missing details. Only patients actually seen by the authors of this study were included.	None
Giannini (control exposed to Glatiramer), 2012	prospective cohort	Patients were regularly followed-up every six months and in the case of relapse. Data were gathered by the neurologist using a standardized information form, notably information on the pregnancies occurring during the study period, focusing on in utero exposure to pharmacological therapies.	Within six months after the delivery, the neurologist administered a semi-structured interview to each patient dealing with pregnancy outcomes and potential confounders. In case of problems, the baby’s clinical charts were reviewed.	None
Giannini (control unexposed, sick), 2012	prospective cohort	Patients were regularly followed-up every six months and in the case of relapse. Data were gathered by the neurologist using a standardized information form, notably information on the pregnancies occurring during the study period, focusing on in utero exposure to pharmacological therapies.	Within six months after the delivery, the neurologist administered a semi-structured interview to each patient dealing with pregnancy outcomes and potential confounders. In case of problems, the baby’s clinical charts were reviewed.	None
Lu (control exposed to Glatiramer), 2012	retrospective cohort	The data on MS and DMD use was generated prospectively by MS specialist neurologists and collected from four MS clinics in BC (Kelowna, Prince George, Vancouver, Victoria).	Perinatal Services of British Columbia (BC) has prospectively collected perinatal data in the BCPDR (BC Perinatal Database Registry)	No adjustment was made for multiple comparisons in this exploratory study.
Lu (control unexposed, sick), 2012	retrospective cohort	The data on MS and DMD use was generated prospectively by MS specialist neurologists and collected from four MS clinics in BC (Kelowna, Prince George, Vancouver, Victoria).	Perinatal Services of British Columbia (BC) has prospectively collected perinatal data in the BCPDR (BC Perinatal Database Registry)	No adjustment was made for multiple comparisons in this exploratory study.
Nguyen (control exposed to Glatiramer), 2019	prospective cohort	Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy.	Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included pregnancy outcomes.	None
Nguyen (control unexposed, sick), 2019	prospective cohort	Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy.	Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included pregnancy outcomes.	None
Portaccio, 2018	prospective cohort	All the patients were regularly followed up every 6 months and in the case of relapse.	Data were collected by the neurologist within 6 months after the delivery using a standardized information form dealing with pregnancy outcomes. In case of problems, the baby’s clinical charts were reviewed.	None
Thiel (control unexposed, sick), 2016	prospective cohort	Women were asked to complete a structured, interviewer-administered questionnaire primarily by phone or in-person during visits to our outpatient clinic after study entry. During pregnancy a detailed history of MS (diagnosis, disease activity, treatments) are obtained.	Follow-up interviews obtained information on the state of pregnancy/delivery, type of delivery, outcome of pregnancy, medication, and well-being of the child. For any adverse outcome in the newborns, the treating pediatrician was contacted to verify the medical problem.	The following potential confounders were considered in the propensity score (PS) model for all outcomes: age at conception, BMI, smoking during pregnancy (yes/no), disease duration, steroid use dur- ing any trimester of pregnancy due to MS relapses (yes/no), and gw of entry into the cohort (categorized around the median).
Weber-Schoendorfer (control exposed to Glatiramer), 2009	prospective cohort	A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known.	Follow-up was conducted by a questionnaire mailed to the patient or her physician and/or the pediatrician. This questionnaire covered the results of the third pediatric check up at the age of 6 weeks.	No adjustment for the outcomes of interest.
Weber-Schoendorfer (control unexposed, disease free), 2009	prospective cohort	A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known.	Follow-up was conducted by a questionnaire mailed to the patient or her physician and/or the pediatrician. This questionnaire covered the results of the third pediatric check up at the age of 6 weeks.	No adjustment for the outcomes of interest.
Weber-Schoendorfer (control unexposed, sick), 2009	prospective cohort	A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known.	Follow-up was conducted by a questionnaire mailed to the patient or her physician and/or the pediatrician. This questionnaire covered the results of the third pediatric check up at the age of 6 weeks.	No adjustment for the outcomes of interest.

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