2014, Volume 16, Issue 5
Strategic Study of CAE >> 2014, Volume 16, Issue 5
Clinical trials of the new 3-dimensional reticular intrauterine device for reproductive women
1. Key Laboratory of Birth Regulation and Control Technology of National Health and Family Planning Commission of China，Shandong Provincial Family Planning Institute of Science and Technology，Jinan 250002，China；
2. Shandong Provincial Key Laboratory for Im
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Abstract
This study aimed at exploring a new 3-dimensional reticular intrauterine device (3-DR-IUD) composed of nitinol and silicone rubber and observing the contraceptive efficacy and side effects of the device in reproductive women. The frame of the 3-DR-IUD was constructed with silicone rubber and nitinol wire. The 3-DR-IUD was placed into uterus in an outpatient procedure. One hundred and fifty- two women were divided equally into the 3-DR-IUD group (n=76) and the 2- dimensional intrauterine device (2- D- IUD) group (n=76，control group). Patient follow-ups were performed in 1～12 months post-operation. The side effects of intrauterine device (IUD)，such as abnormal leucorrhea，menstrual flow changes in uterine bleeding profusely and pain，etc，were investigated. The pregnancy rate，expulsion rate，removal rate of IUD for medical reasons and the continuation rate were evaluated. The ultrasound and pelvic X-ray were carried out to examine IUDs. The results showed that two groups with 76 cases of each successfully placed IUD and there were no severe pain during the operation. The incidence of lumbago/abdominal pain and the occurrence of leucorrhea and irregular vaginal bleeding in the 3-DR-IUD group (7.9 %，6/76) were significantly lower than that of the 2-DIUD group (40.8 %，31/76) during the first 12 months for use of IUD (P<0.000 1). The pregnancy rate，expulsion rate and take-off rate due to symptom were 0 %，0 % and 1.3 % in 3-DRIUD group，respectively，and 1 of 76 woman take-off 3-DR-IUD was due to allergy for silicon rubber. The continuation rate was 98.7 % (75/76) in the 3-DR-IUD group，comparing with the 2-D-IUD group (86.8 % ，66/76)，the difference was significantly (P=0.009). Therefore，the 3-DR-IUD demonstrates long-term patient tolerability，satisfaction and efficacy as a contraceptive.The 3-DR-IUD appears to be a new，safe and effective devise of contraception.
Keywords
3-DR-IUD ; clinical trials ; side effects ; contraceptive efficacy
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