Efficacy and safety of a new uterine cavity-shaped3-dimensional reticular intrauterine device: An clinical trial
QIU Yi, WANG Leiguang, YU Ling, YANG Yan, XU Zhicai, CHEN Feng, LIU Huaqiang, WU Ximei, SONG Yan
Key Laboratory for Techniques for Improving Birth Outcomes, Shandong Provincial Family Planning Institute of Science and Technology, Jinan 250002, China
Abstract：Objective To explore the efficacy and safety of a new uterine cavity-shaped 3-dimensional, reticular intrauterine device (3-DUR-IUD).Methods The 3-DUR-IUD was made from nitinol and silicone rubber. One hundred and thirty-two women were randomly divided into the 3-DUR-IUD group (n=66) (3-DUR-IUD group) or the 2-dimensional IUD (2-D-IUD) group (n=66) (2-D-IUD control group). Patient follow-ups were performed at 1st, 3rd, 6th, and 12th of month post-operation. Side effects such as abnormal leucorrhea, menstrual flow changes in uterine bleeding profusely and pain were recorded. Pregnancy rate, expulsion rate, removal rate of IUD for medical reasons and the continuation rate were evaluated. Ultrasound and pelvic X-ray were used to examine IUDs.Results IUDs were successfully placed in all women in both groups and there were no severe pain during the operation. The rate of the lumbago/abdominal pain and the occurrence of leucorrhea and irregular vaginal bleeding in the 3-DUR-IUD group (6.1%) was significantly lower than that of the 2-D-IUD group (40.9%) during the first 12 months of IUD use. The pregnancy rate, expulsion rate and take-off rate due to symptom were 0, 0 and 0 in the 3-DUR-IUD group, respectively. The continuation rate was 100.0% in the 3-DUR-IUD group as opposed to 86.4% in the 2-D-IUD group.Conclusion The 3-DUR-IUD demonstrates long-term patient tolerability, satisfaction and efficacy as a contraceptive device.
邱毅, 王磊光*, 于玲, 杨燕, 徐志才, 陈峰, 刘华强, 吴喜梅, 宋燕. 新式立体宫腔形网状宫内节育器临床试验研究[J]. 中国生育健康杂志, 2014, 25(4): 305-310.
QIU Yi, WANG Leiguang, YU Ling, YANG Yan, XU Zhicai, CHEN Feng, LIU Huaqiang, WU Ximei, SONG Yan. Efficacy and safety of a new uterine cavity-shaped3-dimensional reticular intrauterine device: An clinical trial. Chinese Journal of Reproductive Health, 2014, 25(4): 305-310.
