1.25.3 Boden2012b
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Clinical evidence – study characteristics tables 1.25.3 BODEN2012B Study ID BODEN2012B Bibliographic reference Boden R, Lundgren M, Brandt L, Reutfors J, Andersen M, Kieler H. Risks of adverse pregnancy and birth outcomes in women treated or not treated with Antenatal and postnatal mental health (update) 319 Clinical evidence – study characteristics tables mood stabilisers for bipolar disorder: Population based cohort study. BMJ (Online). 2012b;345 Methods Prospective/Retrospective: Prospective Data collection: Registries Country: SE Participants Trimester of exposure: Not reported Duration of exposure: Not reported Total N: 358203 N Exposed: 507 N Unexposed: 357696 Mean age (years): 14.6% <25; 63.7% 25-34; 21.7% = >35. Diagnosis: Exposed groups: 90.3% any psychiatric diagnosis; 20.9% schizophrenia; 17.6% other nonaffective psychosis; 11.2% bipolar disorder. Non-exposed group: 8.7% any psychiatric diagnosis; 0.03% schizophrenia; 0.1% other nonaffective psychosis; 0.2% bipolar disorder. Inclusion criteria: All women giving birth in Sweden from July 1, 2005, through December 31, 2009, grouped by filled prescriptions for (1) olanzapine and/or clozapine, the most obesogenic and diabetogenic antipsychotics, (2) other antipsychotics, or (3) no antipsychotics. Exposure was defined as filling a prescription for an antipsychotic (Anatomical Therapeutic Chemical code N05A) from last menstrual period to parturition. Exclusion criteria: Excluded prochlorperazine, levomepromazine, and melperone prescriptions because these drugs are mainly used as antiemetics or anxiolytics with low and intermittently administrated doses. Lithium, which also belongs to the Anatomical Therapeutic Chemical category N05A,was excluded because of its different pharmacological action and placental passage compared with the other compounds in the N05A group and because it is mainly used to treat bipolar disorder. Interventions Drug class: Antipsychotics Drug/s examined: Any Dosage: NR Outcomes Outcomes used: Gestational diabetes, still birth Outcomes not used: Birth weight, birth length, head circumference Study design Cohort Source of funding This study was supported by unrestricted grants from the Lennander’s Foundation and Gillbergska Foundation. Limitations Notes Unable to use birth weight and length outcomes as unajusted event rates not reported. DATA REQUEST Unadjusted ORs for all outcomes for group 1 and group 2 comparison or N births (so can convert reported % to compare events/people in each group) Antenatal and postnatal mental health (update) 320 .