Misoprostol - Medication and Pregnancy KB

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

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