Misoprostol

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Andersen (vs diclofenac), 2016	retrospective cohort (claims database)	niformation on drug use was acquired from the National Prescription Register (Register of Medicinal Product Statistics)	National Hospital Register was used to identify all records of induced abortion [O04, O05 and O06 according to the International Classification of Diseases 10th edition Danish revision (ICD10)] and all records of miscarriage (ICD10-codes O021 and O03)	maternal age (five categories: 20, 20–24, 25–29, 30–34, C35 years), household income (as quartiles), educational length in months (four categories: B143, 144–155, 156–179, C180 months), number of previous miscarriages (four categories: 0, 1, 2, C3) and year of outcome (three categories: 1997–2001, 2002–2006, 2007–2010).
Andersen (vs unexposed), 2016	retrospective cohort (claims database)	niformation on drug use was acquired from the National Prescription Register (Register of Medicinal Product Statistics)	National Hospital Register was used to identify all records of induced abortion [O04, O05 and O06 according to the International Classification of Diseases 10th edition Danish revision (ICD10)] and all records of miscarriage (ICD10-codes O021 and O03)	maternal age (five categories: 20, 20–24, 25–29, 30–34, C35 years), household income (as quartiles), educational length in months (four categories: B143, 144–155, 156–179, C180 months), number of previous miscarriages (four categories: 0, 1, 2, C3) and year of outcome (three categories: 1997–2001, 2002–2006, 2007–2010).
Auffret, 2016	prospective cohort	Pregnant women who had contacted a pharmacovigilance centre (CRPV) between 1 January 1988 and 31 December 2012. Inclusion criteria: 1) exposure to misoprostol before 13WG 2) first contact with the CRPV before 22 weeks of gestation (WG) 3) known pregnancy outcome and examinable newborn or fetus.	mothers' report confirmed by physician
Barbero, 2011	prospective cohort	Interview of mothers during consultation in LSF	Mother's report confirmed by physician in case of malformation	age, niveau de scolarité, activité professionnelle
Brasil, 2000	case control	Standard maternal report	Standard maternal report	maternal age, birth weight
Dal Pizzol, 2008	retrospective cohort	Maternal interview. The specific use of products to induce menstruationwas investigated with the question: “To discoverwhether you were pregnant, did you use some kindof drug for your period to come?”.	Mother’s medical chart. Congenital anomalies were classified according to the 9th Revision of the International Classification of Diseases (ICD-9)	yes but factors were not clearly explained
Opaleye, 2010	case control	Maternal interviews by a trained team by means of a structured questionnaire based on the Latin American Collaborative Study of Congenital Malformations	The search for newborns who met the criteria for inclusion of the sample was given through daily phone calls to each of the hospitals.	no specified
Orioli, 2000	case control	mother's interwiew by a qualified paediatrician in the puerperium.	not specified	not specified
Pastuszak, 1998	case control	misoprostol treatment (indication, route, dose, duration, and complications) was extracted from the records by personnel using a standardized form	clinical geneticists
Vargas, 2000	case control	Structured maternal questionnaire. Possible pregnancy termination attempts and misoprostol use were interrogated by open, semi-open, or closed questions.	Not specified	Matching according to maternal age (± 2 year) and parity
Vauzelle, 2013	prospective cohort	Health care professionales are asked to answer standardized questions referring to specific exposure	a month after he estimated date of birth

master protocol