Selective Serotonin Reuptake Inhibitor (SSRI) - Medication and Pregnancy KB

Selective Serotonin Reuptake Inhibitor (SSRI) updated on 07-01-2025

Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation

R analysis

id	Study	Lib. in paper	Exposition period	Study type All studies Case control excluded Only case control	Control type	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S18622 R79149	Isohata, 2025	Neonatal abstinence syndrome (NAS) (diagnosed using the Isobe score, a modified Finnegan score)	days before delivery	retrospective cohort	unexposed, sick	Adjustment: No Monotherapy: no or not specified	53.19 [2.88;983.26] ^C	5/42 0/177	5	42		ref
S18233 R76475	Rommel, 2022	Postnatal adaptation syndrome (inpatient, outpatient or emergency hospital treatment with an ICD- 10 code of P96.1)	during pregnancy (anytime or not specified)	population based cohort retrospective	unexposed, sick	Adjustment: Yes Monotherapy: SSRI only Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy)	2.51 [1.79;3.50]	-/16,429 -/23,676	-	16,429		ref
S12951 R49154	Heinonen - Sertraline, 2021	Neonatal Abstinence Scale (NAS) (mild, moderate, severe)	3rd trimester	randomized controlled trial	unexposed, sick	Adjustment: Randomisation Monotherapy: SSRI only	0.40 [0.02;10.02] ^C	2/7 1/2	3	7		ref
S13112 R49959	Marks - Sertraline (Controls exposed to Bupropion), 2021	Any adaptation syndrome (Neonatal abstinence syndrome (NAS) or Pediatric adaptation syndromes (PAS))	during pregnancy (anytime or not specified)	retrospective cohort	exposed to other treatment, sick excluded	Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	0.96 [0.57;1.63] excluded (control group)	75/1,653 19/406	94	1,653		ref
S13119 R50006	Marks - Sertraline (Controls unexposed, sick), 2021	Any adaptation syndrome (Neonatal abstinence syndrome (NAS) or Pediatric adaptation syndromes (PAS))	3rd trimester	retrospective cohort	unexposed, sick	Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: recent illness/treatment (during or juste before pregnancy or treatment stopped in view of pregnancy)	1.56 [1.09;2.24]	-/883 -/-	-	883		ref
S12961 R49170	Morimoto, 2021	Neonatal abstinence syndrome	late pregnancy	retrospective cohort	exposed to other treatment, sick	Adjustment: Yes Monotherapy: no or not specified	5.55 [1.76;18.36]	12/33 15/126	27	33		ref
S13015 R49381	Edelson, 2020	Pharmacologic treatment for neonatal abstinence syndrome (NAS)	during pregnancy (anytime or not specified)	retrospective cohort	unexposed, sick	Adjustment: No Monotherapy: no or not specified	2.08 [0.55;7.83] ^C	6/12 12/37	18	12		ref
S8188 R25356	Bhatt-Mehta, 2019	Neonatal abstinence syndrome (NAS)	during pregnancy (anytime or not specified)	retrospective cohort	unexposed, sick	Adjustment: No Monotherapy: no or not specified	1.79 [0.76;4.17]	14/27 41/109	55	27		ref
S8153 R25120	Dave, 2019	Neonatal abstinence syndrome	3rd trimester	nested case control	unexposed (general population or NOS)	Adjustment: Yes Monotherapy: no or not specified	3.16 [2.43;4.11]	138/20,099 521/601,841	659	20,099		ref
S5383 R16585	Yang (Controls unexposed, disease free), 2017	Finnegan signs (a score of 2 or more on the Finnegan Scale).	late pregnancy	prospective cohort	unexposed, disease free excluded	Adjustment: No Monotherapy: SSRI only	1.19 [0.53;2.66] ^C excluded (control group)	14/41 24/79	38	41		ref
S6248 R16591	Yang (Controls unexposed, sick), 2017	Finnegan signs (a score of 2 or more on the Finnegan Scale).	late pregnancy	prospective cohort	unexposed, sick	Adjustment: No Monotherapy: SSRI only Unexposed sick: recent illness/treatment (during or juste before pregnancy or treatment stopped in view of pregnancy)	0.96 [0.44;2.07] ^C	14/41 33/94	47	41		ref
S10062 R36568	Bracero, 2016	Neonatal Abstinence Syndrome (NAS) assessed with the Finnegan scoring system	days before delivery	retrospective cohort	unexposed, sick	Adjustment: No Monotherapy: no or not specified	4.88 [0.55;43.58] ^C	5/6 43/85	48	6		ref
S12948 R49140	Engelstad (Controls unexposed, sick), 2014	Narcotic Withdrawal	during pregnancy (anytime or not specified)	retrospective cohort	unexposed, sick	Adjustment: No Monotherapy: SSRI only	2.05 [0.18;22.88] ^C	2/126 1/128	3	126		ref
S5428 R20543	Colvin, 2012	Withdrawal symptoms from therapeutic use of drugs in newborn	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	26.18 [9.82;69.80]	8/3,297 8/86,110	16	3,297		ref
S5423 R16321	Levinson-Castiel, 2006	Neonatal abstinence syndrome (Finnegan score of 4 or higher)	3rd trimester	retrospective cohort	unexposed, disease free	Adjustment: No Matched Monotherapy: no or not specified	53.05 [3.11;905.15] ^C	18/60 0/60	18	60		ref
S490 R15175	Chambers - Fluoxetine, 1996	Poor neonatal adaptation	late pregnancy	prospective cohort	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	214.11 [12.79;3585.06] ^C	23/73 0/226	23	73		ref
					Total	14 studies	3.50 [2.15;5.69]		922	41,135
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

1: Controls unexposed, sick; 2: Controls unexposed, sick; 3: Controls unexposed, sick;

Sensitivity analysis

Publication bias and p-hacking diagnosis

funnel plot

Asymetry test p-value = 0.2292 (by Egger's regression)

slope=0.7235 (0.2594); intercept=1.0518 (0.8301); t=1.2671; p=0.2292

p values plot

Sub-groups analysis using all included studies

excluded 5383, 13112

Umbrella review (other published meta-analyses)