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Review
. 2015 Oct 26;2015(10):CD007346.
doi: 10.1002/14651858.CD007346.pub3.

Safety of topical corticosteroids in pregnancy

Ching-Chi Chi  1 , Shu-Hui Wang, Fenella Wojnarowska, Gudula Kirtschig, Emily Davies, Cathy Bennett
Affiliations
Review

Safety of topical corticosteroids in pregnancy

Ching-Chi Chi et al. Cochrane Database Syst Rev. .

Abstract

Background: Topical corticosteroids are the most frequently prescribed dermatological treatment and are often used by pregnant women with skin conditions. However, little is known about their safety in pregnancy.

Objectives: To assess the effects of topical corticosteroids on pregnancy outcomes in pregnant women.

Search methods: This is an update of a review previously published in 2009. We updated our searches of the following databases to July 2015: the Cochrane Skin Group Specialised Register, the Cochrane Pregnancy and Childbirth Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 6), MEDLINE, EMBASE, and LILACS. We also searched five trials registers and checked the reference lists of included studies, published reviews, articles that had cited the included studies, and one author's literature collection, for further references to relevant RCTs.

Selection criteria: Randomised controlled trials and cohort studies of topical corticosteroids in pregnant women, as well as case-control studies comparing maternal exposure to topical corticosteroids between cases and controls when studies reported pre-specified outcomes. The primary outcomes included mode of delivery, major congenital abnormality, birth weight, and preterm delivery (delivery before 37 completed weeks gestation); the secondary outcomes included foetal death, minor congenital abnormality, and low Apgar score (less than seven at 5 min).

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Two authors independently applied selection criteria, extracted data, and assessed the quality of the included studies. A third author was available for resolving differences of opinion. A further author independently extracted data from included studies that were conducted by authors of this systematic review.

Main results: We included 7 new observational studies in this update, bringing the total number to 14, including 5 cohort and 9 case-control studies, with 1,601,515 study subjects.Most studies found no causal associations between maternal exposure to topical corticosteroids of any potency and pregnancy outcomes when compared with no exposure. These outcomes included: mode of delivery (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.95 to 1.15, 1 cohort study, n = 9904, low quality evidence); congenital abnormalities, including orofacial cleft or cleft palate and hypospadias (where the urethral opening is on the underside of the penis) (RR 0.82, 95% CI 0.34 to 1.96, 2 cohort studies, n = 9512, low quality evidence; and odds ratio (OR) 1.07, 95% CI 0.71 to 1.60, 1 case-control study, n = 56,557); low birth weight (RR 1.08, 95% CI 0.86 to 1.36; n = 59,419, 4 cohort studies; very low quality evidence); preterm delivery (RR 0.93, 95% CI 0.81 to 1.08, 4 cohort studies, n = 59,419, low quality evidence); foetal death (RR 1.02, 95% CI 0.60 to 1.73, 4 cohort studies, n = 63,885, very low quality evidence); and low Apgar score (RR 0.84, 95% CI 0.54 to 1.31, 1 cohort study, n = 9220, low quality evidence).We conducted stratified analyses of mild or moderate potency, and potent or very potent topical corticosteroids, but we found no causal associations between maternal exposure to topical corticosteroid of any potency and congenital abnormality, orofacial clefts, preterm delivery, or low Apgar score. For low birth weight, although the meta-analysis based on study-level data was not significant for either mild to moderate corticosteroids (pooled RR 0.90, 95% CI 0.74 to 1.09, 3 cohort studies, n > 55,713) or potent to very potent corticosteroids (pooled RR 1.58, 95% CI 0.96 to 2.58, 4 cohort studies, n > 47,651), there were significant differences between the two subgroups (P = 0.04). The results from three of the individual studies in the meta-analysis indicated an increased risk of low birth weight in women who received potent to very potent topical corticosteroids. Maternal use of mild to moderate potency topical steroids was associated with a decreased risk of foetal death (pooled RR 0.70, 95% CI 0.64 to 0.77, 2 studies, n = 48,749; low quality evidence), but we did not observe this effect when potent to very potent topical corticosteroids were given during pregnancy (pooled RR 1.14, 95% CI 0.69 to 1.88, 3 studies, n = 37,086, low quality evidence).We used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group approach to rate the overall quality of the evidence. Data from observational studies started at low quality. We further downgraded the evidence because of imprecision in low birth weight and inconsistency in foetal death. Lower quality evidence resulted in lower confidence in the estimate of effect for those outcomes.

Authors' conclusions: This update adds more evidence showing no causal associations between maternal exposure to topical corticosteroids of all potencies and pregnancy outcomes including mode of delivery, congenital abnormalities, preterm delivery, foetal death, and low Apgar score, which is consistent with the previous version of this review. This update provides stratified analyses based on steroid potency; we found no association between maternal use of topical corticosteroids of any potency and an increase in adverse pregnancy outcomes, including mode of delivery, congenital abnormality, preterm delivery, foetal death, and low Apgar score. Similar to the previous version of the review, this update identified a probable association between low birth weight and maternal use of potent to very potent topical corticosteroids, especially when the cumulative dosage of topical corticosteroids throughout the pregnancy is very large, which warrants further investigation. The finding of a possible protective effect of mild to moderate topical corticosteroids on foetal death could also be examined.

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Conflict of interest statement

Ching‐Chi Chi was involved in two studies included in this review (Chi 2011a; Chi 2013). Shu‐Hui Wang was a coauthor of a cohort study included in this review (Chi 2013). Fenella Wojnarowska was a coauthor of two cohort studies included in this review (Chi 2011a; Chi 2013) but was not involved in data extraction. Gudula Kirtschig has nothing to declare. Emily Davies has nothing to declare. Cathy Bennett is the proprietor of Systematic Research Ltd and received a consultancy fee from the Cochrane Skin Group for her work on this review.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study
1.1
1.1. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 1 Assisted or cesarean delivery (cohort study).
1.2
1.2. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 2 Congenital abnormality (cohort study).
1.3
1.3. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 3 Congenital abnormality (case‐control studies).
1.4
1.4. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 4 Orofacial clefts (cohort studies).
1.5
1.5. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 5 Cleft lip ± palate (cohort studies).
1.6
1.6. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 6 Cleft palate alone (cohort studies).
1.7
1.7. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 7 Orofacial clefts (case‐control studies).
1.8
1.8. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 8 Cleft lip ± palate (case‐control studies).
1.9
1.9. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 9 Cleft palate alone (case‐control studies).
1.10
1.10. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 10 Hypospadias (case‐control studies).
1.11
1.11. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 11 Low birth weight or foetal growth restriction (cohort studies).
1.12
1.12. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 12 Preterm delivery (cohort study).
1.13
1.13. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 13 Foetal death (cohort studies).
1.14
1.14. Analysis
Comparison 1 Topical corticosteroids versus no topical corticosteroids, Outcome 14 Low Apgar score (cohort study).
2.1
2.1. Analysis
Comparison 2 Stratified analysis by corticosteroid potency, Outcome 1 Congenital abnormality (cohort studies).
2.2
2.2. Analysis
Comparison 2 Stratified analysis by corticosteroid potency, Outcome 2 Orofacial clefts (cohort studies).
2.3
2.3. Analysis
Comparison 2 Stratified analysis by corticosteroid potency, Outcome 3 Low birth weight (cohort studies).
2.4
2.4. Analysis
Comparison 2 Stratified analysis by corticosteroid potency, Outcome 4 Preterm delivery (cohort studies).
2.5
2.5. Analysis
Comparison 2 Stratified analysis by corticosteroid potency, Outcome 5 Foetal death (cohort studies).
2.6
2.6. Analysis
Comparison 2 Stratified analysis by corticosteroid potency, Outcome 6 Low Apgar score.
3.1
3.1. Analysis
Comparison 3 Sensitivity analysis after excluding poor quality studies, Outcome 1 Orofacial clefts (case‐control studies).
3.2
3.2. Analysis
Comparison 3 Sensitivity analysis after excluding poor quality studies, Outcome 2 Cleft lip ± palate (case‐control studies).
3.3
3.3. Analysis
Comparison 3 Sensitivity analysis after excluding poor quality studies, Outcome 3 Cleft palate alone (case‐control studies).
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References

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