Clinical performance of the Nova-T380 IUD in routine use by the UK Family Planning and Reproductive Health Research Network: 12-month report.
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 572 Nova-T380 intra-uterine contraceptive devices (IUDs). The Nova-T (and formerly the identical Novagard) IUDs have copper with a surface area of 200 mm(2). The device used in this study, the Nova-T380, has copper with a surface area of 380 mm(2). 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. The 12-month cumulative life-table event rates were: pregnancy 0.8, expulsion 5.6, removal for bleeding or bleeding and pain 11.0. The continuation rate was 73.4. The pregnancy rate at 12 months showed good contraceptive performance. The increased surface area of copper was not associated with a reduced pregnancy rate, but as this was not a direct comparative study with the Nova-T, the influence of the increased area of copper must remain somewhat uncertain. This study found the discontinuation rate for bleeding problems and pain with bleeding to be higher than in other published studies. Other event rates were consistent with other published studies.
Cox
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Institute of Population Studies, School of Postgraduate Medicine and Health Sciences, University of Exeter, UK.
Blacksell
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SE
D000293:Adolescent; D000328:Adult; D005193:Family Planning Services; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007435:Intrauterine Devices, Copper / Q000009:adverse effects / Q000706:statistics & numerical data*; D015993:Life Tables; D008875:Middle Aged; D011247:Pregnancy / Q000706:statistics & numerical data; D006113:United Kingdom