Ziprasidone - Medication and Pregnancy KB

Ziprasidone

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
Huybrechts (Controls unexposed, NOS) 2023	Denmark, Finland, Iceland, Norway, Sweden and USA. 1996 - 2018 population based cohort retrospective	The International Pregnancy Safety Study (InPress) Consortium, a collaboration among research groups from the 5 Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) and the USA (nationwide Medicaid Analytic eXtract).	Pregnancies with 1 or more prescriptions of Ziprasidone during the first trimester, the period for organogenesis.	unexposed (general population or NOS) Pregnancies who did not fill any antipsychotic prescriptions during the 3 months prior to pregnancy until the end of the first trimester.	1st trimester	-9 / 6455324	Overlapping: Data of Huybrechts 2016 totally included in this larger study. Number of Ziprasidone exposures suppressed due to country-/data-specific small cell suppression policies.
Huybrechts (Controls unexposed, NOS) 2023			Exposure to atypical and typical antipsychotics was defined based on filling 1 or more prescriptions of the respective drug class during the first trimester, the period for organogenesis. => Prescription databases.		1st trimester	-9 / 6455324
Huybrechts (Controls unexposed, sick) 2023	Denmark, Finland, Iceland, Norway, Sweden and USA. 1996 - 2018 population based cohort retrospective	The International Pregnancy Safety Study (InPress) Consortium, a collaboration among research groups from the 5 Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) and the USA (nationwide Medicaid Analytic eXtract).	Pregnancies with 1 or more prescriptions of Ziprasidone during the first trimester, the period for organogenesis.	unexposed, sick Pregnancies in women with mental health condition, who did not fill any antipsychotic prescriptions during the 3 months prior to pregnancy until the end of the first trimester.	1st trimester	-9 / 318731	Overlapping: Data of Huybrechts 2016 totally included in this larger study. Number of Ziprasidone exposures suppressed due to country-/data-specific small cell suppression policies.
Huybrechts (Controls unexposed, sick) 2023			Exposure to atypical and typical antipsychotics was defined based on filling 1 or more prescriptions of the respective drug class during the first trimester, the period for organogenesis. => Prescription databases.		1st trimester	-9 / 318731
Park 2018	USA 2000 - 2010 retrospective cohort (claims database)	The Medicaid Analytic eXtract	Pregnant women who had two or more prescriptions dispensed during the first 140 days of their pregnancy for Ziprasidone (also received before pregnancy). Exclusion if more than 1 studied antipsychotic. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Pregnant women who had no prescriptions dispensed for an anti- psychotic medication during the first 140 days of pregnancy were classified as “discontinuers.”	at least 1st trimester	140 / 431	Primary analyses performed individually for each substance (aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone).
Park 2018	USA 2000 - 2010 retrospective cohort (claims database)	The Medicaid Analytic eXtract	The Medicaid Analytic eXtract, nationwide claims database that contains information on pharmacy dispensing records.		at least 1st trimester	140 / 431
Sorensen 2015	Denmark 1997 - 2008 population based cohort retrospective	Nationwide Danish health registries (the Danish National Hospital Register, the Danish National Prescription Register and the Danish Medical Birth Register).	Any prescription of Ziprasidone redeemed by the pregnant women during the exposure window, and recorded in the Danish National Prescription Register. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Unexposed women were defined as pregnant women who did not redeem any prescription of antipsychotic medications during the exposure window.	early pregnancy	41 / 841183	Primary analyses performed on antipsychotics versus unexposed. Authors also analysed each antipsychotic (typical and atypical) substance separately.
Sorensen 2015	Denmark 1997 - 2008 population based cohort retrospective		Any prescription recorded in the Danish National Prescription Register		early pregnancy	41 / 841183

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.

master protocol