Mirtazapine updated on 07-01-2025

Preterm (< 37 weeks)

id	Study   Auto Lee (Controls exposed to SSRI), 2025Lee (Controls unexposed, general pop), 2025Martin, 2024Gungor (Controls exposed to SSRI), 2019Gungor (Controls unexposed, disease free), 2019Gungor (Controls unexposed, sick), 2019Ozturk, 2016Winterfeld (Controls exposed to SSRI), 2015Winterfeld (Controls unexposed, NOS), 2015Djulus (Controls exposed to other antidepressants), 2006Djulus (Controls unexposed, disease free), 2006	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimesterPaternal exp. genotoxic window only (0–3 months preconception)Paternal exposure: epigenetic window only (3–xxx months preconception)Paternal exposure: genotoxic/epigenetic window (0–xxx months preconception)Paternal exposure: other window	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedsiblingwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S18444 R78316	Lee (Controls exposed to SSRI), 2025	Preterm birth (infant born at gestational age <37 weeks)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	1.35 [0.66;2.76] C excluded (control group)	9/77   131/1,465	140	77		ref
S18417 R77885	Lee (Controls unexposed, general pop), 2025	Preterm birth (infant born at gestational age <37 weeks)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	1.47 [0.73;2.96]	9/77   28,543/463,440	28,552	77		ref
S18309 R77104	Martin, 2024	Preterm delivery (delivery at <259 days (37 weeks’))	during pregnancy (anytime or not specified)	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	1.47 [1.27;1.69]	232/2,658   119,950/2,408,707	120,182	2,658		ref
S12919 R49008	Gungor (Controls exposed to SSRI), 2019	Preterm (less than 37 completed weeks of gestation)	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	0.82 [0.08;8.55] C excluded (control group)	1/16   3/40	4	16		ref
S12920 R49014	Gungor (Controls unexposed, disease free), 2019	Preterm (less than 37 completed weeks of gestation)	during pregnancy (anytime or not specified)	prospective cohort	unexposed, disease free excluded	Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	1.47 [0.08;25.32] C excluded (control group)	1/16   1/23	2	16		ref
S12921 R49020	Gungor (Controls unexposed, sick), 2019	Preterm (less than 37 completed weeks of gestation)	during pregnancy (anytime or not specified)	prospective cohort	unexposed, sick	Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: old history of illness/treatment (> 12 months before pregnancy) or not specified	1.47 [0.08;25.32] C	1/16   1/23	2	16		ref
S11789 R43377	Ozturk, 2016	Preterm Births (<37 weeks)	at least 1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	3.99 [0.19;83.55] C	0/4   8/246	8	4		ref
S12913 R48985	Winterfeld (Controls exposed to SSRI), 2015	Preterm delivery	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No Matched Monotherapy: no or not specified	1.06 [0.63;1.78] excluded (control group)	31/279   32/302	63	279		ref
S12914 R48992	Winterfeld (Controls unexposed, NOS), 2015	Preterm delivery	1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: No Matched Monotherapy: no or not specified	1.33 [0.77;2.30]	31/279   26/302	57	279		ref
S12911 R48964	Djulus (Controls exposed to other antidepressants), 2006	Preterm birth (< 37 wk gestation)	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No Matched Monotherapy: no or not specified	1.62 [0.58;4.49] C excluded (control group)	10/77   7/83	17	77		ref
S12910 R48959	Djulus (Controls unexposed, disease free), 2006	Preterm birth (< 37 wk gestation)	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No Matched Monotherapy: no or not specified	6.72 [1.42;31.67] C	10/77   2/92	12	77		ref
					Total	6 studies	1.48 [1.29;1.69]		148,813	3,111
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 12911, 12913, 12919, 12920, 18444

Umbrella review (other published meta-analyses)