A randomized trial on the clinical performance of Nova T (R) 380 and Gyne T (R) 380 slimline copper IUDs

作者：Haugan Tommy; Skjeldestad Finn Egil^*; Halvorsen Lars Erik; Kahn Henriette

来源：Contraception, 2007, 75(3): 171-176.

DOI：10.1016/j.contraception.2006.09.005

• Nova T (R) 380
• Gyne T (R) 380 Slimline
• copper IUD
• clinical performance
• bleeding
• pain
• contraceptive failures
• partial expulsion
• total expulsion

Purpose: The objective of this open randomized study was to compare the clinical performance of Nova T (R) 380 and Gyne T (R) 380 Slimline copper intrauterine devices (IUDs).
Materials and 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 T (R) 380 users than for Gyne T (R) 380 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 T (R) 380 Slimline users than for Nova T (R) 380 users (the 5-year cumulative rates were 3.4% and 1.1,% respectively, per 100 women). No other major differences in reasons for disconfirmation 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.
Conclusion: Clinical performance was considered satisfactorily high for both devices.

• 出版日期2007-3