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The fetal safety of hydrocortisone-pramoxine (Proctofoam-HC) for the treatment of hemorrhoids in late pregnancy.

Author(s): Ebrahimi N, Vohra S, Gedeon C, Akoury H, Bernstein P, Pairaudeau N, Cormier J, Dontigny L, Arsenault MY, Fortin C, Goyet M, Lafortune C, Lalande J, Beauchamp C, Engel F, Fortin A, Taddio A, Einarson T, Koren G

Affiliation(s): Motherisk Program, Hospital for Sick Children, Toronto ON.

Publication date & source: 2011-02, J Obstet Gynaecol Can., 33(2):153-8.

Publication type: Clinical Trial; Multicenter Study; Research Support, Non-U.S. Gov't

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.

Page last updated: 2011-12-09

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