Trazodone - Medication and Pregnancy KB

Trazodone

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Chan (Controls exposed to SSRIs), 2024	China 2003 - 2018	All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals between January 1, 2003 and December 31, 2018.	Infants of women with prescription of Trazodone only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester.	exposed to other treatment, sick Infants of women with prescription of Selective-serotonin-reuptake-inhibitors (SSRI) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester.	35 / 956
Chan (Controls unexposed, pop general), 2024	China 2003 - 2018	All pregnant women aged 15–50 years who gave a singleton livebirth or stillbirth (≥20 weeks of gestation) in public hospitals between January 1, 2003 and December 31, 2018.	Infants of women with prescription of Trazodone only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester.	unexposed (general population or NOS) Infants of pregnant women who were not prescribed with any antidepressant within 90 days before the last menstrual period and during the first trimester.	35 / 462377
Einarson, 2009	Canada Not specified.	Women call the service for information regarding the safety of a drug.	Pregnant women who were exposed to Trazodone in the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnant women who were not exposed to antidepressants and who had called Motherisk for information regarding nonteratogenic drugs.	17 / 928
Khazaie (Controls exposed to diphenhydramine), 2013	Iran 2008 - 2012	Pregnant Persian women (gestational ages from 26 to 30 weeks) seeking treatment for sleep disturbance at the psychiatric outpatient clinic at KUMS.	Pregnant participants that received a single dose of trazodone (50 mg/day).	exposed to other treatment, sick Pregnant participants that received a single dose of diphenhydramine (25 mg/day).	18 / 19	The psychiatric interview was performed to exclude volunteers with any other psychiatric disorder such as baseline depression, as well as to confirm the diagnosis of insomnia for which participants were originally referred for treatment.
Khazaie (Controls unexposed, sick), 2013	Iran 2008 - 2012	Pregnant Persian women (gestational ages from 26 to 30 weeks) seeking treatment for sleep disturbance at the psychiatric outpatient clinic at KUMS.	Pregnant participants that received a single dose of trazodone (50 mg/day).	unexposed, sick Pregnant participants that received a single dose of placebo.	18 / 18	The psychiatric interview was performed to exclude volunteers with any other psychiatric disorder such as baseline depression, as well as to confirm the diagnosis of insomnia for which participants were originally referred for treatment.
Ozturk, 2016	Turkey 2007 - 2012	Pregnant women referred to the prenatal consultation service for psychotropic drug exposure.	Pregnant women exposed to Trazodone during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnant women selected from the non-teratogen exposed pregnancies in the same year.	1 / 275	'Drug exposures took place in 81% during the first trimester, and 11% in all three trimesters. Medical treatments were discontinued in most of recognized pregnancies.'=> considered as 'At least first trimester'.
Palmsten a (Controls exposed to SSRIs), 2013	USA 2000 - 2007	Pregnant women with a depression diagnosis enrolled in Medicaid.	Pregnant women with a depression diagnosis and a dispensation of Trazodone in monotherapy during the exposure window.	exposed to other treatment, sick Pregnant women with a depression diagnosis and a dispensation of selective serotonin reuptake inhibitor (SSRI) in monotherapy during the exposure window.	339 / 19000	Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy.
Palmsten a (Controls unexposed, sick), 2013	USA 2000 - 2007	Pregnant women with a depression diagnosis enrolled in Medicaid.	Pregnant women with a depression diagnosis and a dispensation of Trazodone in monotherapy during the exposure window.	unexposed, sick Pregnant women with a depression diagnosis and no antidepressant exposure between the LMP and the end of the window.	339 / 59219	Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy.
Palmsten b, 2013	USA 2000 - 2007	Subcohort of pregnancies in women with diagnoses for mood or anxiety disorders (between one and five months before delivery), ending in live birth among women aged 12-55.	Women with a supply of Trazodone monotherapy that overlapped with the delivery date. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Women who had no supply of antidepressants in the five months before delivery.	139 / 69044	Exclusion of women who were exposed to both drugs types (polytherapy) during the five months before delivery.
Yaris, 2005	Turkey 1999 - 2004	Pregnant women calling for a counseling about the teratogenic risks of drugs, chemicals, and X-ray.	Women who were exposed to Trazodone during pregnancy for depression, anxiety, and psychotic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Women who did not use any drug while pregnant.	1 / 248	Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. Raw data for premature delivery not reported because the denominator is not clearly stated.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Anderson, 2020	USA 1997 - 2011	The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect.	The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas.	30630 / 11478	'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.'
Laspro, 2024	USA 2013 - 2023	Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37).	Newborns without oral clefts.	12098 / -9	P-values were calculated, while to account for multiple testing (693 hypotheses) Benjamini- Hochberg (BH) corrections were performed with a false discovery rate (Q) of 0.05.

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