Corticosteroids during pregnancy and oral clefts: a case-control study

Area of Science:

• Obstetrics and Gynecology
• Pediatrics
• Teratology

Background:

• The association between first-trimester corticosteroid exposure and congenital malformations, specifically oral clefts, remains unclear.
• Existing research has not definitively established whether systemic corticosteroid use during early pregnancy poses a risk for oral clefts in infants.

Purpose of the Study:

• To investigate the potential relationship between maternal corticosteroid use during the first trimester of pregnancy and the occurrence of nonsyndromic oral clefts in newborns.
• To evaluate the risk of oral clefts associated with first-trimester corticosteroid exposure, considering potential confounding factors.

Main Methods:

• A case-control study utilizing data from the Spanish Collaborative Study of Congenital Malformations (ECEMC).
• Inclusion of 1,184 liveborn infants diagnosed with nonsyndromic oral clefts as case subjects.
• Logistic regression analysis was performed to assess the association, controlling for variables like maternal smoking, hyperthermia, family history of clefts, and other medication use.

Main Results:

• A statistically significant association was found between maternal corticosteroid exposure during the first trimester and an increased risk of cleft lip (with or without cleft palate) in newborns (OR = 6.55; CI = 1.44-29.76; P = 0.015).
• The observed risk was adjusted for key potential confounders, strengthening the study's findings.

Conclusions:

• The findings suggest that systemic corticosteroid use during the first trimester of pregnancy should be reserved for life-threatening conditions, situations lacking safer alternatives, or replacement therapy.
• Recommendations are made to restrict corticosteroid prescriptions during early pregnancy due to the identified risk of oral clefts.