Clozapine - Medication and Pregnancy KB

Clozapine

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Huybrechts (Controls unexposed, NOS), 2023	Denmark, Finland, Iceland, Norway, Sweden and USA. 1996 - 2018	All pregnancies resulting in singleton live-born infants (for Nordic cohorts) and publicly insured mothers linked to their live-born infants (for USA).	Pregnancies with 1 or more prescriptions of the Clozapine 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.	-9 / 6455324	Number of exposed pregnancies suppressed due to data-specific small cell suppression policies. Overlapping: Data of Ellfolk 2021 totally included in this larger study. Data of Reis 2008 (Sweden; 1995-2005) not included in this study (Sweden: 2006-2016).
Huybrechts (Controls unexposed, sick), 2023	Denmark, Finland, Iceland, Norway, Sweden and USA. 1996 - 2018	All pregnancies resulting in singleton live-born infants (for Nordic cohorts) and publicly insured mothers linked to their live-born infants (for USA).	Pregnancies with 1 or more prescriptions of the Clozapine 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.	-9 / 318731	Number of exposed pregnancies suppressed due to data-specific small cell suppression policies. Overlapping: Data of Ellfolk 2021 totally included in this larger study. Data of Reis 2008 (Sweden; 1995-2005) not included in this study (Sweden: 2006-2016).
Kulkarni, 2024	Australia 2005 - 2019	Women who were pregnant or had a baby in the last 12 months, taking antipsychotic medication during pregnancy, and living in Australia.	Women who had a diagnosis of a schizophrenia spectrum disorder and took clozapine (at minimum) during the first trimester of pregnancy.	unexposed, sick Women with a diagnosis of schizophrenia spectrum disorder who chose not to take any antipsychotic during the first trimester of pregnancy (at a minimum).	14 / 24
McKenna, 2005	Canada, Israel and England Not specified	Women who contacted the line for information.	Women who has taken Clozapine within 3 months of pregnancy or during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Subsequent woman who contacted the TIS regarding exposure to a non-teratogenic agent. Women who reported a psychiatric diagnosis or psychotropic medication use were excluded from the comparison group.	6 / 151	All of the women were exposed in the first trimester.
Peng, 2013	China 2007 - 2010	Women with singleton pregnancy at more than 38 weeks who were seeking prenatal care in the department of the Second Xiangya Hospital.	Women with a diagnosis of schizophrenia who were taking clozapine throughout the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Women who not have any mental disorder and were not treated with any antipsychotics in the same department.	33 / 76	Continuous variables: there were no significant differences between the two groups in the Apgar score at 1 and 5 min, as well as the mean weight, height, and brain circumference.
Reis (Control exposed to FGA), 2008	Sweded 1995 - 2005	Whole country (1.4% of all deliveries in Sweden are missing in the register).	Women who had reported the use of Clozapine in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Women who had reported the use in early pregnancy of 'Any first-generation antipsychotic'. (This is a subgroup of exposure among the whole exposed group considered in the study).	18 / 435	Atypical and typical antipsychotics are subgroups of the entire study. Atypical versus Typical. OR and adjustement performed for other groups. Relative severe malformations, with exclusion of known chromosome anomalies.
Reis (Unexposed control, NOS), 2008	Sweden 1995 - 2005	Whole country (1.4% of all deliveries in Sweden are missing in the register)	Women who had reported the use of Clozapine in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) All other women in the register.	18 / 958729	Atypical antipsychotics are a subgroup of the entire study. OR and adjustement performed for other groups. Relative severe malformations, with exclusion of known chromosome anomalies.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

5 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol