Amisulpride - Medication and Pregnancy KB

Amisulpride

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
Habermann (Control exposed to FGA) 2013	Germany 1997 - 2009 prospective cohort	Teratology Information Service (TIS Berlin)	Women exposed to amisulpride during pregnancy; comedication with First Generation Antipsycotics (FGA) was allowed. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Women exposed to First Generation Antipsycotics (FGAs) excluding comedication with Second Generation Antipsycotics (SGA) (cohort I).	1st trimester	16 / 284	Primary analyse on all Atypical Antipsychotics but Raw data are provided for some substances. Cases with potentially embryo- or fetotoxic drugs were not excluded for both the study cohort and the comparison cohort I but were assessed afterward.
Habermann (Control exposed to FGA) 2013	Germany 1997 - 2009 prospective cohort	Teratology Information Service (TIS Berlin)	Data ascertainment was performed using 2 structured questionnaires at (1) the first contact and (2) 8 weeks after the estimated date of birth. A detailed history of drug use is recorded at the first contact.		1st trimester	16 / 284
Habermann (Control unexposed, disease free) 2013	Germany 1997 - 2009 prospective cohort	Teratology Information Service (TIS Berlin)	Women exposed to amisulpride during pregnancy; comedication with First Generation Antipsycotics (FGA) was allowed. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Women exposed to teratogenic, fetotoxic, or insufficiently studied agents were excluded as described elsewhere (cohort II).	1st trimester	16 / 1122	Primary analyse on all Atypical Antipsychotics but Raw data are provided for some substances. Cases with potentially embryo- or fetotoxic drugs were not excluded for both the study cohort and the comparison cohort I but were assessed afterward.
Habermann (Control unexposed, disease free) 2013	Germany 1997 - 2009 prospective cohort	Teratology Information Service (TIS Berlin)	Data ascertainment was performed using 2 structured questionnaires at (1) the first contact and (2) 8 weeks after the estimated date of birth. A detailed history of drug use is recorded at the first contact.		1st trimester	16 / 1122

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

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

Empty. There are no case-control studies available for this drug.

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