Document Detail

The fetal safety of hydrocortisone-pramoxine (Proctofoam-HC) for the treatment of hemorrhoids in late pregnancy.
MedLine Citation:
PMID:  21352635     Owner:  NLM     Status:  MEDLINE    
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.
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
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstétrique et gynécologie du Canada : JOGC     Volume:  33     ISSN:  1701-2163     ISO Abbreviation:  J Obstet Gynaecol Can     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-02-28     Completed Date:  2011-07-11     Revised Date:  2011-08-01    
Medline Journal Info:
Nlm Unique ID:  101126664     Medline TA:  J Obstet Gynaecol Can     Country:  Canada    
Other Details:
Languages:  eng     Pagination:  153-8     Citation Subset:  IM    
Motherisk Program, Hospital for Sick Children, Toronto ON.
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MeSH Terms
Anesthetics, Local / adverse effects*
Anti-Inflammatory Agents / adverse effects*
Birth Weight
Drug Combinations
Fetal Development / drug effects*
Hemorrhoids / drug therapy*
Hydrocortisone / adverse effects*
Morpholines / adverse effects*
Pregnancy Complications / drug therapy*
Pregnancy Trimester, Third
Reg. No./Substance:
0/Anesthetics, Local; 0/Anti-Inflammatory Agents; 0/Drug Combinations; 0/Morpholines; 50-23-7/Hydrocortisone; 78457-00-8/proctofoam-HC
Erratum In:
J Obstet Gynaecol Can. 2011 May;33(5):436

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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