对宫型IUD放置器性能的多中心临床评价

A Multi - center Randomized Comparative Clinical Trial on Evaluation the Performances of Uterine Shaped IUD Inserters

目的:对叉式器、凹槽Ⅰ型、内藏式及凹槽Ⅱ型4种宫型IUD放置器的性能进行评估。方法:采用多中心随机比较性临床研究方法。结果:上述4种放置器的观察例数分别为409、403、402和386。4组受试对象的年龄、孕产次、末次妊娠结局、哺乳情况、子宫位置及宫腔深度均具有可比性。叉式器在曲度调整、放置前是否需要扩张宫颈、进入或退出宫颈时的顺利程度及抵达宫底的满意程度等方面均优于其它3种放置器,放置者对其操作的简便程度的满意率达62.5％,有46.3％的放置者建议将其列为首位优选。内藏式放置器在操作的可靠程度上的满意率最高,为51.6％,缺点是少数放置者感到在使放置器抵达宫底(7.3％)或退出时(8.1％)易出现问题,故对操作有一定要求。结论:叉式和内藏式放置器有较好的推广前景。

Objective: To evaluate the performances of 4 types of Uterine shaped IUD Inserters. Methods: A multi - center randomized comparative clinical trial was conducted. Results: There were 409,403,402 and 386 subjects to be allocated to each of the groups. Their characteristics in terms of age,parity,gravidity,outcome of the last pregnancy, breastfeeding .position and depth of the uterus were compatible. The fork style in-sertor was accepted well due to its easy use. Its flexibility made it easier to be inserted and withdrawn without dilatation of the cervix. The satisfaction rate to its easy use is 62. 5%. 46. 3% providers gave the first priority to it. For another inserter,the IUD should be pulled into its tube before insertion. It was satisfied(51. 6% ) with its reliable insertion procedure. But some providers had some problems on putting the IUD up to the u-terine funds(7. 3% ) or taking out the insertor(8. 1% ). It seems that more experiences would be requested. Conclusion:The above two types of inserter could be recommended.