Clozapine - Medication and Pregnancy KB

Clozapine

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 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.	1st 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, 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 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.	1st 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).
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
Kulkarni 2024	Australia 2005 - 2019 prospective cohort	National Register of Antipsychotic Medication in Pregnancy (NRAMP), 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).	at least 1st trimester	14 / 24
Kulkarni 2024	Australia 2005 - 2019 prospective cohort		Pregnant women were interviewed and monitored by the research team. With consent, information was also sought from treating clinicians and medical records.		at least 1st trimester	14 / 24
McKenna 2005	Canada, Israel and England Not specified prospective cohort	Motherisk Program, Israeli Teratogen Information Service and Drug safety research unit database	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.	1st trimester	6 / 151	All of the women were exposed in the first trimester.
McKenna 2005	Canada, Israel and England Not specified prospective cohort		Exposure declared by women during exposure and data were achieved by sending each general practitioner a detailed questionnaire with questions regarding drug history.		1st trimester	6 / 151	All of the women were exposed in the first trimester.
Peng 2013	China 2007 - 2010 prospective cohort	Department of obstetrics/ gynecology of the Second Xiangya Hospital, Central South University, China,	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.	throughout pregnancy	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.
Peng 2013	China 2007 - 2010 prospective cohort		A detailed questionnaire completed by all enrolled pregnant women prior to delivery. Once the questionnaire was completed, permission was requested to receive a report from the physician and obstetrician.		throughout pregnancy	33 / 76
Reis (Control exposed to FGA) 2008	Sweded 1995 - 2005 population based cohort retrospective	Swedish Medical Birth 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).	early pregnancy	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 (Control exposed to FGA) 2008	Sweded 1995 - 2005 population based cohort retrospective	Swedish Medical Birth Register	Maternal drug use in early pregnancy is recorded from interviews performed by the midwife at the first antenatal care visit, usually before the end of the first trimester.		early pregnancy	18 / 435
Reis (Unexposed control, NOS) 2008	Sweden 1995 - 2005 population based cohort retrospective	Swedish Medical Birth 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.	early pregnancy	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.
Reis (Unexposed control, NOS) 2008	Sweden 1995 - 2005 population based cohort retrospective	Swedish Medical Birth Register	Maternal drug use in early pregnancy is recorded from interviews performed by the midwife at the first antenatal care visit, usually before the end of the first trimester		early pregnancy	18 / 958729

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