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

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.