metaPreg - Duloxetine during pregnancy

Duloxetine 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)	1.03 [0.84, 1.27]	5%	6 studies	31,093	4,405	not evaluable	ROB	-
Major congenital malformations	1.03 [0.84, 1.27]	5%	6 studies	31,093	4,405	not evaluable	ROB	-
Congenital heart defects	1.32 [0.94, 1.85]	0%	2 studies	162	3,976	not evaluable	ROB	-
Abdominal wall defects	0.45 [0.21, 0.96]	-	1 study		2,532	not evaluable	ROB	3.87 [.; 1.26]
Digestive system anomalies	1.06 [0.45, 2.49]	65%	2 studies	39	3,966	not evaluable	ROB	-
Eye defects	0.67 [0.24, 1.91]	0%	2 studies	13	3,966	not evaluable	ROB	-
Genital anomalies	1.10 [0.56, 2.19]	0%	2 studies	13	3,966	not evaluable	ROB	-
Limb defects	0.54 [0.33, 0.89]	0%	2 studies	56	3,966	not evaluable	ROB	3.09 [.; 1.51]
Nervous system anomalies	0.88 [0.31, 2.53]	0%	2 studies		3,966	not evaluable	ROB	-
Oro-facial clefts	1.16 [0.31, 4.31]	0%	2 studies		3,966	not evaluable	ROB	-
Respiratory system anomalies	1.03 [0.40, 2.67]	0%	2 studies		3,966	not evaluable	ROB	-
Urinary malformations	1.18 [0.64, 2.18]	0%	2 studies	14	3,966	not evaluable	ROB	-
Ear malformations	-	-	0 study					-
Ear, face and neck anomalies	6.00 [0.72, 49.92]	-	1 study		1,434	not evaluable	ROB	-
Minor congenital malformations	1.24 [0.89, 1.73]	-	1 study	157	1,444	not evaluable	ROB	-
Other anomalies/syndromes (non chromosomal)	1.75 [0.73, 4.18]	-	1 study	22	1,434	not evaluable	ROB	-
Other congenital malformations (Q80 to Q99)	1.33 [0.41, 4.30]	-	1 study		2,532	not evaluable	ROB	-
Growth parameters and prematurity
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Preterm (< 37 weeks)	1.82 [1.32, 2.51]	71%	7 studies	201,709	1,658	serious	ROB	3.04 [1.96; .]
Small for gestational age (weight)	1.01 [0.76, 1.36]	30%	4 studies	116,759	1,487	not evaluable	ROB	-
Maternal consequences
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Preeclampsia	1.11 [0.95, 1.29]	0%	2 studies	48,770	3,059	not evaluable	ROB	-
Postpartum hemorrhage	1.53 [1.08, 2.17]	-	1 study	96,022	955	not evaluable	ROB	2.43 [1.36; .]
Neonatal disorders
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Low Apgar score (< 7) (at 5 min)	1.59 [1.21, 2.08]	0%	2 studies	31,112	1,656	not evaluable	ROB	2.55 [1.72; .]
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation	4.76 [2.28, 9.95]	-	1 study		59	not evaluable	ROB	8.99 [3.98; .]
Jaundice / Icterus	0.97 [0.57, 1.66]	-	1 study	84	139	not evaluable	ROB	-
Neonatal medical care	2.04 [1.29, 3.23]	-	1 study	146	139	not evaluable	ROB	3.50 [1.90; .]
Neonatal tachypnea	1.89 [1.06, 3.37]	-	1 study	56	139	not evaluable	ROB	3.18 [1.30; .]
Persistent pulmonary hypertension	8.85 [0.36, 218.46]	-	1 study	1	139	not evaluable	ROB	-
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	1.79 [0.68, 4.71]	78%	3 studies	321	1,200	not evaluable	ROB	-
Elective/induced termination of pregnancy	1.41 [1.21, 1.64]	0%	2 studies	733	1,200	not evaluable	ROB	2.18 [1.72; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths	0.83 [0.25, 2.74]	-	1 study	11	1,559	not evaluable	ROB	-
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