Misoprostol

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Andersen (vs diclofenac), 2016 Danemark
1997-2011
birth identified using the Medical Birth registry, induced abortions and miscarriage identified using The National Hospital 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
166 / 5911 5911 only exposed to diclofenac
Andersen (vs unexposed), 2016 Danemark
1997-2011
birth identified using the Medical Birth registry, induced abortions and miscarriage identified using The National Hospital 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
166 / 1338658 5911 only exposed to diclofenac
Auffret, 2016
unexposed, disease free
233 / 232
Barbero, 2011 Argentine
dddd
Linea Salud Fetal (TIS del Centre nacional de Génética Medica pregnancies exposed to misoprostol during the first trimester exposed to other treatment, sick
pregnancies not exposed or exposed to no teratogens
94 / 401 15 % de perdues de vue dans les exposées et 14 % dans les non exposées
Dal Pizzol, 2008 Brazil
Brazilian Study on Gestational Diabetes, a multicenter cohort that investigated diabetes and glucose intolerance in pregnant women. The sample consisted of women 20 years or older who were in the 21st to 28th week of pregnancy, and who consecu- tively sought care at prenatal services in health units under the Unified National Health System 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
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.
Vauzelle, 2013 France
CRAT pregnancies exposed to misoprostol before 12 GW unexposed, disease free
pregnancies exposed non teratogens with a gestationnal age at call less than 18 GW
236 / 255

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Brasil, 2000 Brasil
babies weighing less than 1500g with congenital malformations of various types babies weighing less than 1500 g without congenital anomalies 37 / 387 used of misoprostol mainly in 1st trimester.
Opaleye, 2010 Brasil
July-November 2005
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. 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
Orioli, 2000 South america
1989-1995
malformed newborns with specific defects All others defects 34 / 4639 4980 malformed newborn infants observed inthis period we subtracted 307 with known genetic orambiental syndromes, allowing 4673 malformed and4980 controls
Pastuszak, 1998 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. 96 / 96
Vargas, 2000 Brazil
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. 93 / 279

master protocol