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

AbstractOBJECTIVE:
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.
AuthorsNeda 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
JournalJournal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC (J Obstet Gynaecol Can) Vol. 33 Issue 2 Pg. 153-158 (Feb 2011) ISSN: 1701-2163 [Print] Netherlands
PMID21352635 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Anesthetics, Local
  • Anti-Inflammatory Agents
  • Drug Combinations
  • Morpholines
  • proctofoam-HC
  • Hydrocortisone
Topics
  • Adult
  • Anesthetics, Local (adverse effects)
  • Anti-Inflammatory Agents (adverse effects)
  • Birth Weight
  • Drug Combinations
  • Female
  • Fetal Development (drug effects)
  • Hemorrhoids (drug therapy)
  • Humans
  • Hydrocortisone (adverse effects)
  • Morpholines (adverse effects)
  • Pregnancy
  • Pregnancy Complications (drug therapy)
  • Pregnancy Trimester, Third

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