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The Fetal Safety of Hydrocortisone-Pramoxine (Proctofoam-HC) for the Treatment of Hemorrhoids in Late Pregnancy
Authors:Neda Ebrahimi  Sabina Vohra  Christelle Gedeon  Hani Akoury  Paul Bernstein  Nicholas Pairaudeau  Johanne Cormier  Lorraine Dontigny  Marc-Yvon Arsenault  Claude Fortin  Martine Goyet  Chantal Lafortune  Johanne Lalande  Coralie Beauchamp  Francis Engel  Anne Fortin  Anna Taddio  Tom Einarson  Gideon Koren
Affiliation:1. Motherisk Program, Hospital for Sick Children Toronto ON;2. Sunnybrook Health Sciences Centre, Toronto ON;3. Mount Sinai Hospital, Toronto ON;4. North York General Hospital, Toronto ON;5. LaSalle Clinic Montreal QC;1. Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver BC;2. Child & Family Research Institute, Vancouver BC;3. Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver BC;4. Department of Medical Genetics, University of British Columbia, Vancouver BC
Abstract:
ObjectiveFetal 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.MethodsIn a multicentre study, 240 women exposed to Proctofoam-HC in the third trimester and a similar number of control pregnant women were followed up postnatally.ResultsWhen 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.ConclusionProctofoam-HC is safe to use in the treatment of hemorrhoids in late pregnancy.
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