Misoprostol

Exposed non-exposed, cohort studies

Study Country
Study period
Study design		 Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Andersen (vs diclofenac)
2016 		Danemark
1997-2011
retrospective cohort (claims database) 		Medical birth registry to identify all pregnancies ending in a birth National Hospital Register to identify all records of induced abortion` National prescription Register redemption of a prescription of diclofenac/misoprostol between conception and the 84 th day of the pregnancy or if the pregnancy was shorter than 84 days to the end of pregnancy unexposed (general population or NOS)
women exposed to diclofenac only 		1st trimester 166 / 5911 5911 only exposed to diclofenac
niformation on drug use was acquired from the National Prescription Register (Register of Medicinal Product Statistics)
Andersen (vs unexposed)
2016 		Danemark
1997-2011
retrospective cohort (claims database) 		Medical birth registry to identify all pregnancies ending in a birth National Hospital Register to identify all records of induced abortion` National prescription Register redemption of a prescription of diclofenac/misoprostol between conception and the 84 th day of the pregnancy or if the pregnancy was shorter than 84 days to the end of pregnancy unexposed (general population or NOS)
No first trimester exposure to misoprostol/diclofenac 		1st trimester, preconception-only 166 / 1338658 5911 only exposed to diclofenac
niformation on drug use was acquired from the National Prescription Register (Register of Medicinal Product Statistics)
Auffret
2016

prospective cohort 		unexposed, disease free
1st trimester 233 / 232
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.
Barbero
2011 		Argentine
dddd
prospective cohort 		Prospective cohort (TIS) pregnancies exposed to misoprostol during the first trimester exposed to other treatment, sick
pregnancies not exposed or exposed to no teratogens 		1st trimester, during pregnancy (anytime or not specified) 94 / 401 15 % de perdues de vue dans les exposées et 14 % dans les non exposées
Interview of mothers during consultation in LSF
Dal Pizzol
2008 		Brazil

retrospective cohort 		retrospective cohort The specific use of products to induce menstruation was investigated with the question: “To discover whether you were pregnant, did you use some kind of drug for your period to come?”. unexposed (general population or NOS)
non-exposed 		1st trimester 120 / 4573 4,856 women (87.3%). 708 women were excluded due to lack of informationon use of drugs to induce menstruation andmaternal characteristics like age, schooling, andskin color, among others.
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?”.
Vauzelle
2013 		France

prospective cohort 		Prospective cohort (TIS) pregnancies exposed to misoprostol before 12 GW unexposed, disease free
pregnancies exposed non teratogens with a gestationnal age at call less than 18 GW 		1st trimester 236 / 255
Health care professionales are asked to answer standardized questions referring to specific exposure

Case-control studies

Study Country
Study period
Study design		 Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Brasil
2000 		Brasil

case control 		not clearly specified babies weighing less than 1500g with congenital malformations of various types babies weighing less than 1500 g without congenital anomalies Standard maternal report during pregnancy (anytime or not specified) 37 / 387 used of misoprostol mainly in 1st trimester.
Standard maternal report
Opaleye
2010 		Brasil
July-November 2005
case control 		four public maternities in Fortaleza (CE) for the identification of newborns with malformations and paired controls newborns with malformations identified in four maternities in Fortazela Control was considered as the first live or dead newborn with no MF and the same sex, born in the same hospital immediately after a case was detected. Maternal interviews by a trained team by means of a structured questionnaire based on the Latin American Collaborative Study of Congenital Malformations during pregnancy (anytime or not specified) 126 / 126 The questionnaires were reviewed immediately after the interview and compared to other information from hospitalization records, medical records and examinations, and possible doubts were elucidated with the clinical staff accompanying the case
The search for newborns who met the criteria for inclusion of the sample was given through daily phone calls to each of the hospitals.
Orioli
2000 		South america
1989-1995
case control 		malformed newborns with specific defects All others defects mother's interwiew by a qualified paediatrician in the puerperium. 1st trimester 34 / 4639 4980 malformed newborn infants observed inthis period we subtracted 307 with known genetic orambiental syndromes, allowing 4673 malformed and4980 controls
not specified
Pastuszak
1998 		Brazil

case control 		seven hospitals in Brazil Möbius’ syndrome defined as bilateral or unilateral facial-nerve paralysis with or without other neurologic signs or malformations infants born during the same period who were given a diagnosis of a neural-tube defect (meningocele, meningomyelocele, anencephaly, or encephalocele) by the same clinical geneticists at the same hospitals within the first week of life. misoprostol treatment (indication, route, dose, duration, and complications) was extracted from the records by personnel using a standardized form 1st trimester 96 / 96
clinical geneticists
Vargas
2000 		Brazil

case control 		eight participating clinical genetic centers during a 21-month study period. all those children in which at least one of the malformations fit in the spectrum of vascular disruption defects congenital malformations classified as not to be caused by vascular disruption. Structured maternal questionnaire. Possible pregnancy termination attempts and misoprostol use were interrogated by open, semi-open, or closed questions. 1st trimester 93 / 279
Not specified

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

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