Topical corticosteroid use in pregnancy is not associated with an increased risk for small gestational age (SGA) or low birth weight in newborns, according to study findings published in JAMA Dermatology.
Investigators included all pregnancies that resulted in live births recorded in the Danish Medical Birth Registry from January 1, 1997, to December 31, 2016. Data regarding topical corticosteroid use was obtained from the Registry of Medicinal Product Statistics.
SGA and low birth weight were the primary outcomes. Secondary analysis assessed the individual risk for the 5 most prevalently used topical corticosteroids in Denmark—hydrocortisone (mild), hydrocortisone butyrate (moderate), beta-methasone (potent), mometasone (potent), and clobetasol (very potent).
The researchers identified 60,498 pregnancies that were exposed to topical corticosteroids. The median gestational age at the first filled prescription for a topical corticosteroid was day 112 (interquartile range [IQR], 44-181 days), and the median amount received was 30 g (IQR, 30-60 g; mean, 53.6 g). The matched cohort included 60,497 exposed and 241,986 unexposed pregnancies.
A total of 5678 topical corticosteroid-exposed pregnancies (9.4%) led to an infant with SGA, vs 22,634 unexposed pregnancies (9.4%) (relative risk ratio [RR], 1.00; 95% CI, 0.98-1.03, absolute risk difference [ARD], 0.3; 95% CI, -2.3 to 2.9 per 1000 pregnancies). Infants with low birth weight were observed in 2006 exposed pregnancies (3.3%) and in 8675 unexposed pregnancies (3.6%) (RR, 0.92; 95% CI, 0.88-0.97; ARD, -2.7; 95% CI, -4.3 to -1.1).
Stratified analysis by each of the most commonly used topical corticosteroids identified no significant increased risks for the outcomes.
Regarding pregnancies exposed to potent to very potent topical corticosteroids, SGA was observed in 2662 births (9.6%) and low birth weight in 928 births (34%) (RR, 1.03; 95% CI, 0.99-1.07; ARD, 2.8; 95% CI, -0.9 to 6.5 per 1000 pregnancies for SGA and RR, 0.94; 95% CI, 0.88-1.00; ARD, -2.3; 95% CI, -4.5 to 0.0 per 1000 pregnancies for low birth weight) vs the main comparative group of unexposed pregnancies.
Post hoc analysis revealed no significant associations with SGA (RR, 1.17; 95% CI, 0.95-1.46; ARD, 16.8; 95% CI, -6.7 to 40.4 per 1000 pregnancies) or low birth weight (RR, 1.14; 95% CI, 0.81-1.60; ARD, 5.9; 95% CI, -10.1 to 21.9 per 1000 pregnancies). Very low birthweight was found in 6 exposed pregnancies (0.7%) and in 25 matched unexposed pregnancies (0.7%) (RR, 0.96; 95% CI, 0.40-2.33), for an ARD of -0.3 (95% CI, -6.6 to 6.1) per 1000 pregnancies.
The researchers noted that although the study found no significant increased risk in any of the analyses, residual confounding cannot be excluded. Also, the indication for a prescribed drug was unattainable from the Registry of Medicinal Product Statistics, and data regarding adherence to filled prescriptions were not available.
“Although the findings cannot definitively rule out the possibility of an increased risk, a moderate to large increase in the rates is unlikely,” the study authors commented. “Thus, these findings suggest that topical corticosteroids, including potent to very potent agents, in large amounts can be used in pregnancy without increased concerns of SGA and low birth weight.”
Disclosures: One of the study authors declared affiliations with pharmaceutical companies. Please see the original reference for a full list of disclosures.
Andersson NW, Skov L, Andersen JT. Evaluation of topical corticosteroid use in pregnancy and risk of newborns being small for gestational age and having low birth weight. JAMA Dermatol. Published online May 5, 2021. doi: 10.1001/jamadermatol.2021.1090