Objective: Fetal safety has never been studied for any drug used in the treatment of hemorrhoids. Proctofoam-HC is a combination of a corticosteroid and a local anaesthetic that is proven effective for the treatment of hemorrhoids. The objective of this study was to assess prospectively the fetal safety of third trimester exposure to Proctofoam-HC.
Methods: In a multicentre study, 204 [corrected] women exposed to Proctofoam-HC in the third trimester and a similar number of control pregnant women were followed up postnatally.
Results: When compared to controls exposure to Proctofoam-HC was not associated with any adverse fetal effects on birth weight, gestational age, rates of prematurity, or pre- or postnatal complications.
Conclusion: Proctofoam-HC is safe to use in the treatment of hemorrhoids in late pregnancy.