Table 4 Publications reporting statistical analyses of the risk of congenital malformation associated with gestational exposure to asthma medication compared with no exposure

Reference	Gestational exposure	Children with congenital malformation(number born to women with asthma/without asthma)	Multivariate analysis	Increased risk†
Schatz et al7	Inhaled bronchodilators	<50/<50*	Yes	No
Stenius-Aarniala et al11	Theophylline	10/2	No	No
Schatz et al8	β agonists, theophylline, cromolyn, CS, antihistamines, decongestants	<50/<50*	No	No
Alexandre et al10	β agonists, CS	88/981	Yes	No
Schatz et al39	β agonist, ICS, OCS, theophylline, cromoglicates	42/0*	No	No
Tamasi et al13	SABA, ICS, LABA, OCS, xanthines, sodium cromoglicate	511/22322‡	No	Yes with fenoterol, no with other medications
Blais et al38	ICS	418/0	Yes	No
Bakhireva et al37	β agonists, leucotriene receptor antagonists	9/1	Yes	Yes
Kallen et al14	SABA, ICS, LABA, other bronchodilators¶, other anti-inflammatories**	1263/41223	Yes	Yes§
Current publication	SABA, ICS, LABA, OCS, other bronchodilators¶, other anti-inflammatories**	704/4420	Yes	No

*Numbers estimated from published percentages (no numbers presented in paper).
†Statistically significant increase in malformation with gestational drug exposure (at 5% level).
‡Mostly major malformations but included some minor (clubfoot, pyloric stenosis, undescended testis).
§Although system-specific malformations had no generally consistent pattern and statistically significant associations found only for severe cardiac defects, orofacial clefts, anal atresia.
¶Other bronchodilators: aminophylline, theophylline, ephedrine, orciprenaline, tiotropium or ipratropium.
**Other anti-inflammatories: cromoglicate, nedocromil, montelukast or zafirlukast.
CS, corticosteroid (unspecified formula); ICS, inhaled corticosteroid; LABA, long-acting β agonist; OCS, oral corticosteroid; SABA, short-acting β agonist.