Document Detail

Clinical performance of the Nova T380 intrauterine device in routine use by the UK Family Planning and Reproductive Health Research Network: 5-year report.
MedLine Citation:
PMID:  12396775     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The purpose of the study was to evaluate the pregnancy and complication rates of this new device, with its increased area of copper, in comparison with other published results, in the clinical setting of British general practice and family planning clinics. DESIGN: Doctors working in general practice and at family planning clinics throughout the UK who collaborate in the UK Family Planning and Reproductive Health Research Network were responsible for the fitting of 574 Nova T380 intrauterine contraceptive devices (IUDs). The Nova T (and formerly the identical Novagard IUDs have copper with a surface area of 200 mm(2). The Nova T380 has copper with a surface area of 380 mm(2). RESULTS: This is the first 5-year report on this device. The 5-year cumulative life-table event rates per 100 women were pregnancy 2.0, expulsion 13.0, and removal for bleeding problems and bleeding with pain 29.6. CONCLUSIONS: The increased surface area of copper was associated with a reduced pregnancy rate as compared to the Nova T though no statistical comparison is possible. Although the present study was not a direct comparative study with the Nova T, the result lends weight to the notion that increasing the copper reduces the pregnancy rate. The discontinuation rate for bleeding problems and bleeding with pain and the expulsion rates were higher than in published Nova T studies.
Michael Cox; John Tripp; Sarah Blacksell;
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The journal of family planning and reproductive health care / Faculty of Family Planning & Reproductive Health Care, Royal College of Obstetricians & Gynaecologists     Volume:  28     ISSN:  1471-1893     ISO Abbreviation:  J Fam Plann Reprod Health Care     Publication Date:  2002 Apr 
Date Detail:
Created Date:  2002-10-24     Completed Date:  2002-11-29     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  101087687     Medline TA:  J Fam Plann Reprod Health Care     Country:  England    
Other Details:
Languages:  eng     Pagination:  69-72     Citation Subset:  IM    
Consultant Obstetrician and Gynecologits (Retired), Nuneaton, UK.
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MeSH Terms
Device Removal / statistics & numerical data
Great Britain / epidemiology
Intrauterine Devices, Copper* / adverse effects
Life Tables
Pelvic Inflammatory Disease / epidemiology,  etiology
Pregnancy Rate
Uterine Hemorrhage / epidemiology,  etiology

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

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