A randomized trial on the clinical performance of Nova T380 and Gyne T380 Slimline copper IUDs.
OBJECTIVE
The objective of this open randomized study was to compare the clinical performance of Nova T380 and Gyne T380 Slimline copper intrauterine devices (IUDs).


METHODS
Eligible for analyses were 957 Norwegian parous women aged 18-45 years. Clinical performance was measured upon the removal of IUD due to contraceptive failure, expulsion, bleeding, pain, pelvic inflammatory disease and other medical reasons during a 5-year study period.


RESULTS
The discontinuation rate due to contraceptive failure was significantly higher in the first year for Nova T380 users than for Gyne T380 Slimline users, whereas no differences were observed thereafter (the 5-year cumulative failure rates were 4.4% and 2.2%, respectively, per 100 women). However, the partial expulsion rate was significantly higher in the first year for Gyne T380 Slimline users than for Nova T380 users (the 5-year cumulative rates were 3.4% and 1.1,% respectively, per 100 women). No other major differences in reasons for discontinuation were found between the study groups. There was a slight nonsignificant increase in hemoglobin levels for both study groups over the course of the study.


CONCLUSIONS
Clinical performance was considered satisfactorily high for both devices.
Haugan
Tommy
T
Department of Epidemiology, SINTEF Health Research, N-7465 Trondheim, Norway.
Skjeldestad
Finn Egil
FE
Halvorsen
Lars Erik
LE
Kahn
Henriette
H
D000293:Adolescent; D000328:Adult; D020878:Device Removal / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007433:Intrauterine Device Expulsion / Q000209:etiology*; D007435:Intrauterine Devices, Copper / Q000009:adverse effects; D008875:Middle Aged; D000292:Pelvic Inflammatory Disease / Q000453:epidemiology* / Q000209:etiology; D017699:Pelvic Pain / Q000453:epidemiology / Q000209:etiology; D011247:Pregnancy; D018873:Pregnancy Rate; D049168:Pregnancy, Unplanned; D014592:Uterine Hemorrhage / Q000453:epidemiology* / Q000209:etiology