metaPreg - Tramadol (versus unexposed) during pregnancy

Tramadol (versus unexposed) updated on 07-09-2025

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)	1.26 [1.04, 1.52]	46%	5 studies	95,719	7,467	not evaluable	ROB	1.82 [1.23; .]
Major congenital malformations	1.29 [1.04, 1.60]	53%	5 studies	66,059	7,467	not evaluable	ROB	1.90 [1.24; .]
Congenital heart defects	1.22 [0.98, 1.52]	1%	4 studies	21,235	7,352	not evaluable	ROB	-
Digestive system anomalies	1.46 [0.63, 3.39]	58%	3 studies	2,625	5,576	not evaluable	ROB	-
Oro-facial clefts	1.00 [0.51, 1.98]	0%	3 studies	803	5,576	not evaluable	ROB	-
Urinary malformations	1.76 [1.20, 2.58]	0%	3 studies	856	5,576	not evaluable	ROB	2.92 [1.70; .]
Eye defects	0.86 [0.31, 2.42]	0%	2 studies	125	4,795	not evaluable	ROB	-
Genital anomalies	0.88 [0.46, 1.69]	0%	2 studies	422	4,795	not evaluable	ROB	-
Limb defects	0.91 [0.61, 1.35]	0%	2 studies	616	4,795	not evaluable	ROB	-
Nervous system anomalies	1.94 [1.15, 3.29]	0%	2 studies	406	4,795	not evaluable	ROB	3.30 [1.56; .]
Other anomalies/syndromes (non chromosomal)	0.78 [0.40, 1.50]	0%	2 studies	528	4,795	not evaluable	ROB	-
Cardiac septal defects	1.78 [1.06, 3.00]	-	1 study	8,907	1,776	not evaluable	ROB	2.96 [1.30; .]
Club foot / Talipes equinovarus	3.63 [1.78, 7.40]	-	1 study	2,284	1,776	not evaluable	ROB	6.72 [2.96; .]
8 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)	1.40 [1.17, 1.68]	0%	2 studies	9,502	1,545	not evaluable	ROB	2.15 [1.60; .]
5 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
Long term consequences
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Tumors in infants	4.71 [1.98, 11.19]	-	1 study	891	781	not evaluable	ROB	8.89 [3.38; .]
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	1.92 [1.04, 3.53]	97%	3 studies	12,560	9,042	not evaluable	ROB	3.24 [1.24; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths	3.70 [0.58, 23.74]	42%	2 studies	329	1,753	not evaluable	ROB	-
Elective/induced termination of pregnancy	4.52 [2.51, 8.15]	-	1 study	52	150	not evaluable	ROB	8.52 [4.46; .]
Intrauterine deaths (as a whole or unspecified)	2.02 [1.73, 2.37]	-	1 study	9,339	1,602	not evaluable	ROB	3.46 [2.85; .]
1 non statistically significant endpoints reported in only one study