Importance Topical corticosteroids are indicated for pregnant women with skin conditions, but their safety in pregnancy is not fully understood.
Objective To investigate whether maternal exposure to topical corticosteroids results in adverse pregnancy outcomes.
Design Retrospective cohort study.
Setting United Kingdom National Health Service.
Participants A total of 2658 pregnant women exposed to topical corticosteroid and 7246 unexposed pregnant women.
Exposure Topical corticosteroids dispensed during pregnancy.
Main Outcomes and Measures Orofacial cleft, low birth weight, preterm delivery, fetal death, low Apgar score, and mode of delivery.
Results No associations of maternal topical corticosteroid exposure with orofacial cleft, low birth weight, preterm delivery, fetal death, low Apgar score, and mode of delivery were found in the primary analysis (adjusted risk ratio [RR], 1.85 [95% CI, 0.22-15.20] [P = .57]; 0.97 [95% CI, 0.78-1.19] [P = .75]; 1.20 [95% CI, 0.73-1.96] [P = .48]; 1.07 [95% CI, 0.56-2.05] [P = .84]; 0.84 [95% CI, 0.54-1.31] [P = .45]; and P = .76, respectively). Stratified analyses based on potency did not reveal any significant associations in most of these categories either, but an exploratory analysis showed a significantly increased risk of low birth weight when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy (adjusted RR, 7.74 [95% CI, 1.49-40.11]; P = .02).
Conclusions and Relevance This study reassuringly showed no associations of maternal topical corticosteroid exposure with orofacial cleft, preterm delivery, fetal death, low Apgar score, and mode of delivery. With this study and all available evidence taken together, the risk of low birth weight seems to correlate with the quantity of topical corticosteroid exposure.
Topical corticosteroids are the most frequently used drugs for treating skin conditions and are prescribed to more than 6% of pregnant women,1(p130) but their safety in pregnancy is not fully understood. Topical corticosteroids are teratogenic and result in fetal growth restriction in animals.2- 3 However, pharmacology references do not offer explicit instructions on prescribing topical corticosteroids in pregnancy.4 The prescribing information of topical corticosteroids states that they should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The US Food and Drug Administration (FDA) labels topical corticosteroids as pregnancy risk category C, meaning that animal studies have shown adverse fetal effects, but there are no adequate and well-controlled studies in pregnant women.5(ppxxiii-xxiv)
The current available evidence on the safety of topical corticosteroid use in human pregnancy is limited.6- 7 Many of the previous studies only investigated the relation between topical corticosteroid use in early pregnancy and orofacial cleft.8- 12 The results were inconsistent: 1 small case-control study showed a link between maternal first-trimester use of topical corticosteroids and orofacial cleft,11 but other studies found no such association.9- 10,12- 14 A recent Cochrane review6- 7 has highlighted potential problems with low birth weight (LBW). A hospital-based cohort study showed significant associations of use of very potent topical corticosteroids with lower plasma cortisol levels, decreased placental weight, and LBW infants.15 Our previous population-based cohort study also found a significant association between maternal exposure to potent or very potent topical corticosteroids and fetal growth restriction.14 However, no similar associations were found in an earlier study.16 Therefore, the available data on the effects of topical corticosteroid use on pregnancy outcomes are inconclusive. The objective of this study was to investigate whether maternal exposure to topical corticosteroids has adverse effects on pregnancy by examining a comprehensive set of outcomes.
参考文献：Ching-Chi Chi et al. Pregnancy Outcomes After Maternal Exposure to Topical Corticosteroids: A UK Population-Based Cohort Study. JAMA Dermatol. Published online September 04, 2013. doi:10.1001/jamadermatol.2013.5768