metaPreg - Mirtazapine during pregnancy

Mirtazapine updated on 10-20-2025

Table Graphic exposition period:

Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)	1.02 [0.72, 1.43]	20%	8 studies	53,496	2,003	not evaluable	ROB	-
Major congenital malformations	1.02 [0.72, 1.43]	20%	8 studies	53,496	2,003	not evaluable	ROB	-
Congenital heart defects	1.14 [0.56, 2.32]	0%	2 studies	8,109	661	not evaluable	ROB	-
Cleft lip with or without cleft palate	-	-	0 study					-
Cleft palate	-	-	0 study					-
Oro-facial clefts	-	-	0 study					-
1 non statistically significant endpoints reported in only one study
Growth parameters and prematurity
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Preterm (< 37 weeks)	1.48 [1.29, 1.69]	0%	6 studies	148,813	3,111	not evaluable	ROB	2.32 [1.91; .]
Low birth weight (< 2500g)	1.47 [0.48, 4.46]	28%	2 studies	31,363	93	not evaluable	ROB	-
Small for gestational age (weight)	1.56 [0.87, 2.79]	45%	2 studies	236,438	2,427	not evaluable	ROB	-
2 non statistically significant endpoints reported in only one study
Maternal consequences
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Caesarean	1.01 [0.64, 1.58]	0%	2 studies	111,692	93	not evaluable	ROB	-
Postpartum hemorrhage	0.71 [0.30, 1.70]	0%	2 studies	19,757	206	not evaluable	ROB	-
3 non statistically significant endpoints reported in only one study
Neonatal disorders
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Neonatal medical care	0.96 [0.31, 2.99]	0%	2 studies	8,573	93	not evaluable	ROB	-
Low Apgar score (< 7) (at 5 min)	1.11 [0.81, 1.52]	0%	2 studies	32,761	2,309	not evaluable	ROB	-
Neonatal death (< 28 days of life)	2.08 [0.14, 30.02]	81%	2 studies	651	974	not evaluable	ROB	-
3 non statistically significant endpoints reported in only one study
Long term consequences
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Child/Infant death (> 28 days of life)	23.20 [1.43, 376.35]	-	1 study	130	77	not evaluable	ROB	45.90 [2.22; .]
Intrauterine deaths
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions	1.53 [0.83, 2.85]	46%	4 studies	1,225	2,016	not evaluable	ROB	-
Therapeutic terminations of pregnancy	2.13 [1.17, 3.87]	0%	3 studies	16	461	not evaluable	ROB	3.68 [1.62; .]
Elective/induced termination of pregnancy	2.29 [1.25, 4.21]	57%	3 studies	64	364	not evaluable	ROB	4.01 [1.81; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths	0.97 [0.39, 2.43]	0%	2 studies	34	2,049	not evaluable	ROB	-
1 non statistically significant endpoints reported in only one study
Neuro-developmental disorders
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
4 non statistically significant endpoints reported in only one study