Clinical performance of the Nova-T®380 IUD in routine use by the UK Family Planning and Reproductive Network: 12-month report Health Research

Abstract

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-T®380 intra-uterine contraceptive devices (IUDs). The Nova-T® (and formerly the identical Novagard®) IUDs have copper with a surface area of 200 mm2. The device used in this study, the Nova-T®380, has copper with a surface area of 380 mm2. 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.

Clinical performance of the Nova T380<SUP>®</SUP> intrauterine device in routine use by the UK Family Planning and Reproductive Health Research Network: 5-year report

“…Four pregnancies occurred during the first 12 months of the study and were described in the 12-month report. 1 The remaining four pregnancies are described below. It is notable that of the eight cases, four were associated with partial expulsion and one with complete expulsion of the IUD.…”

“…One additional case that occurred at 3 months of use was reported after the end of the first 12 months and so was not included in the 12-month report. 1 The IUD was removed in six cases though two of them were recorded as removed because of pain. Therefore, although ten women are reported with PID in Table 6, only four removals for PID are recorded in Table 3.…”

“…1,2 It has been suggested that the contraceptive efficacy of copper intrauterine devices (IUDs) correlates positively to the area of copper-releasing surface but the evidence has been conflicting. [3][4][5][6] Nevertheless it is now generally thought that increased copper does reduce pregnancy rates and prolong usability of the device.…”

As the world grows: contraception in the 21st century

“…There have been some advances in contraceptive development in the years since the first contraceptive revolution provided by the oral contraceptive (OC) pill regimen (4-6), e.g., the development of Copper T380A and levonorgestrel-releasing (LNG-releasing) intrauterine devices (IUDs) (7)(8)(9). However, most of the advances have, in fact, been developments of new delivery methods for existing and novel hormonal steroids, mostly acting by inhibition of ovulation.…”

Estudo dopplerfluxométrico das artérias uterinas antes e após inserção do DIU

“…Os principais efeitos colaterais estão relacionados a alterações no ciclo menstrual, ocasionando menorragia 4,5 , dismenorréia 6 , assim como seu deslocamento inferior, tornando-o mal posicionado 7,8 . Alguns autores como Colli et al 6 e Wang et al 9 demonstraram a relação entre a menorragia e a presença do DIU ao descreverem o papel de enzimas lisossômicas na origem desta manifestação clínica.…”