[Medicated stainless steel ring-165, medicated gamma-intrauterine devices and TCu220C: a multicenter comparative study]
Author(s): Zhuang L, Yang B, Yuan H
Affiliation(s): Shanghai International Peace Maternal and Child Health Hospital.
Publication date & source: 1997-02, Zhonghua Fu Chan Ke Za Zhi., 32(2):97-101.
Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial
OBJECTIVE: A five-year multicenter comparative study was conducted to observe the clinical efficacy, side effects, and menstrual blood loss (MBL) of medicated stainless steel ring 165 (MSSR-165), medicated gamma-Intrauterine devices (gamma-IUD) (both containing indomethacin and copper) and TCu220C for exploring new kinds of IUD to reduce MBL after IUD insertion. METHODS: MSSR-165 and medicated gamma-IUD, with TCu220C as a control, were randomly inserted (one thousand in each group) in women 12 hospitals nation wide in October 1988. Follow-ups were performed at the time of 3, 6, 12, 24, 36, 48 and 60 months after IUD insertion. The efficacy of the IUDs was calculated with life table method. A quantitative comparison of MBL was made before and 3, 6, 12, 24, 36 and 60 months after the IUD insertion in 20 volunteers. RESULTS: At the end of 5 years, the pregnancy rates of MSSR-165, medicated gamma-IUD and TCu220C were 3.2, 2.7 and 3.2. The expulsion rates were 7.7, 2.3 and 2.4, while the removal rates for medical reasons were 5.0, 3.8 and 6.4. The cumulative continuation rates were 79.8, 88.7 and 84.9 per 100 women respectively. The average total bleeding time in the first year of MSSR-165 was 22 days, the shortest one among the three IUDs. The quantitative comparison of MBL showed that the gamma-IUD reduced the MBL and the TCu220C increased the MBL apparently. CONCLUSION: With good clinical efficacy, short menstrual bleeding time, as well as the same appearance and insertion technic as stainless steel ring, the MSSR-165 will be easily accepted at the grass root level. The gamma-IUD had good clinical efficacy and higher continuation rate, whereas the side effect of bleeding was not obvious. Both medicated SSR165 and gamma-IUD could be recommended for promotion.