Document Detail


Prevention of unexplained recurrent spontaneous abortion using intravenous immunoglobulin: a prospective, randomized, double-blinded, placebo-controlled trial.
MedLine Citation:
PMID:  9506206     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PROBLEM: The efficacy of intravenous immunoglobulin (IVIG) for treatment of unexplained recurrent spontaneous abortion was assessed in a prospective, randomized, double-blinded, and placebo-controlled study. METHOD OF STUDY: The study took place in a provincial recurrent pregnancy loss clinic, located in a tertiary/quaternary care academic center. The study subjects were women with a history of two or more documented consecutive spontaneous pregnancy losses under 20 weeks of gestation, excluding any associated with aneuploidy by karyotype analysis, and with no evidence of genetic, endocrine, infectious, anatomic, or autoimmune factors associated with a history of recurrent spontaneous abortion. The subjects were randomized to receive either intravenous immunoglobulin (Gamimune N) as treatment or normal saline as placebo. Randomization was stratified for primary, secondary, and unclassified unexplained recurrent spontaneous abortion. Success was defined as an ongoing pregnancy beyond 20 weeks of gestation. RESULTS: Sixty-two subjects enrolled in the trial. There were 37 index pregnancies and 6 cross-over pregnancies. There was no clinically significant difference between the treatment arm and the placebo arm in terms of subsequent pregnancy success. There seemed to be a higher success rate with the stratified analysis of couples with secondary unexplained recurrent spontaneous abortion, but the trial did not have sufficient power to confirm this. CONCLUSIONS: Based on this trial and three similar trials in the literature, a multicentered trial is needed to determine conclusively whether IVIG is effective in the treatment of unexplained recurrent spontaneous abortion.
Authors:
M D Stephenson; K Dreher; E Houlihan; V Wu
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of reproductive immunology (New York, N.Y. : 1989)     Volume:  39     ISSN:  1046-7408     ISO Abbreviation:  Am. J. Reprod. Immunol.     Publication Date:  1998 Feb 
Date Detail:
Created Date:  1998-04-28     Completed Date:  1998-04-28     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8912860     Medline TA:  Am J Reprod Immunol     Country:  DENMARK    
Other Details:
Languages:  eng     Pagination:  82-8     Citation Subset:  IM    
Affiliation:
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Vancouver, Canada.
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MeSH Terms
Descriptor/Qualifier:
Abortion, Habitual / immunology,  prevention & control*,  therapy
Adult
Aneuploidy
Double-Blind Method
Female
Humans
Immunoglobulins, Intravenous / therapeutic use*
Immunosuppression
Infant, Newborn
Male
Pregnancy
Pregnancy Outcome
Prospective Studies
Chemical
Reg. No./Substance:
0/Immunoglobulins, Intravenous

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


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