- Medication and Pregnancy KB

master protocol

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Broms (Controls exposed to other treatments), 2020	population based cohort retrospective	The national prescribed drug registers. Information was also identified from the National Patient Register (Denmark), from the register for biologic treatment (Finland) and from the ARTIS and PsoReg registers (Sweden).	Medical birth registers and patient registers. The registers prospectively record information on pregnancy, delivery and the neonatal period.	No adjustment for this group of exposure.
Broms (Controls unexposed, disease free), 2020	population based cohort retrospective	The national prescribed drug registers. Information was also identified from the National Patient Register (Denmark), from the register for biologic treatment (Finland) and from the ARTIS and PsoReg registers (Sweden).	Medical birth registers and patient registers. The registers prospectively record information on pregnancy, delivery and the neonatal period.	No adjustment for this group of comparison.
Bröms (controls unexposed, disease free), 2016	population based cohort retrospective	The national registers on prescribed drugs. Anti-TNF treatment also identified from visits recorded in the patient register covering all Danish hospitals using a specific treatment code (Denmark) or from the ARTIS and PsoReg registers (Sweden).	The national medical birth registers and patient registers.	No adjustment for this control group.
Bröms (controls unexposed, sick), 2016	population based cohort retrospective	The national registers on prescribed drugs. Anti-TNF treatment also identified from visits recorded in the patient register covering all Danish hospitals using a specific treatment code (Denmark) or from the ARTIS and PsoReg registers (Sweden).	The national medical birth registers and patient registers.	Adjusted for country, chronic inflammatory diagnosis, maternal age, parity, smoking, BMI, multiple birth.
Casanova, 2013	retrospective cohort	Data were obtained from the review of medical records and an interview with the patient when additional information was necessary was conducted. Collected data including data on drugs received during 3 months before conception and during pregnancy.	Data were obtained from the review of medical records and an interview with the patient when additional information was necessary was conducted. Collected data including data on delivery, pregnancy complications and neonatal complications.	No adjustment for this group of exposure.
De Lorenzo (Controls unexposed, disease free), 2020	retrospective cohort	Data were collected retrospectively during paediatric consultations.	Data were collected retrospectively during paediatric consultations.	None
De Lorenzo (Controls unexposed, sick), 2020	retrospective cohort	Data were collected retrospectively during paediatric consultations.	Data were collected retrospectively during paediatric consultations.	None
Hyrich, 2006	retrospective cohort	The British Society for Rheumatology Biologics Register (BSRBR) database was searched for all reports of pregnancy. Details on exposure to disease-modifying antirheumatic drugs (DMARDs) and biologic drugs were collected using standardized forms.	The British Society for Rheumatology Biologics Register (BSRBR) database was searched for all reports of pregnancy. Details on maternal and fetal outcomes were collected using standardized forms.	None
Langen, 2014	retrospective cohort	Data were collected from review of medical records and included medication use.	Data were collected from review of medical records and included pregnancy outcomes.	None
Lichtenstein, 2018	prospective cohort	Patient data were collected at registry enrollment by gastroenterologists and then semi-annually (January, July), including medication use, concomitant CD medication use; and the number of infliximab infusions before, during, and after pregnancy.	Patient data were collected at registry enrollment by gastroenterologists and then semi-annually (January, July), including pregnancy outcomes.	None (No a priori sample size estimates were performed and no adjustment was made for multiple comparisons)
Schnitzler (Unexposed control, disease free), 2011	prospective cohort	Patients were treated with IFX or with ADA in our IBD unit at the University Hospital in Leuven and were prospectively followed.	Data on pregnancy outcome were obtained from hospital files, from family doctors, and from the patients themselves. A detailed questionnaire was also sent out to all patients and/or the patients were intensively interviewed during the contacts in the outpatient clinics.	No match/adjustment for this group of exposure.
Schnitzler (Unexposed control, sick), 2011	prospective cohort	Patients were treated with IFX or with ADA in our IBD unit at the University Hospital in Leuven and were prospectively followed.	Data on pregnancy outcome were obtained from hospital files, from family doctors, and from the patients themselves. A detailed questionnaire was also sent out to all patients and/or the patients were intensively interviewed during the contacts in the outpatient clinics.	None
Seirafi, 2014	retrospective cohort	Inclusion: patient records from hospital IBD units and patients were contacted by phone when data were missing. During pregnancy, information collected included dose and duration of anti-TNFs and concomitant treatments.	Inclusion: patient records from hospital IBD units and patients were contacted by phone when data were missing. During pregnancy, information collected included pregnancy outcomes. Term and mode of delivery, and newborn characteristics were also recorded.	None
Vinet (Unexposed controls, disease free), 2018	retrospective cohort	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing drug prescription claims.	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing data on hospitalizations and outpatient visits. Serious infections in the offspring was based on ≥1 hospitalization with infection within the first 12 months of life.	No matching for this group of exposure.
Vinet (Unexposed controls, sick), 2018	retrospective cohort	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing drug prescription claims.	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing data on hospitalizations and outpatient visits. Serious infections in the offspring was based on ≥1 hospitalization with infection within the first 12 months of life.	None
Weber-Schoendorfer, 2015	prospective cohort	Data were collected on exposure (including both prescription and over-thecounter) from structured telephone or face-to-face interviews and/or mailed questionnaires obtained from both the mother and/or her physician(s) after oral informed consent.	Data were collected on outcome from structured telephone or face-to-face interviews and/or mailed questionnaires obtained from both the mother and/or her physician(s) after oral informed consent. Blinded classification according EUROCAT.	No adjustment for this group of exposure.