Yaron Michal, Viviano Manuela, Guillot Cecile, Aharon Arnon, Shkolnik Ketty
a Department of Women-Children-Teenagers , Geneva University Hospitals , Geneva , Switzerland.
b OCON Healthcare , Modiin , Israel.
Eur J Contracept Reprod Health Care. 2019 Aug;24(4):288-293. doi: 10.1080/13625187.2019.1618447. Epub 2019 Jun 6.
The aim of the study was to assess the acceptability of the intrauterine ball IUB Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians. In this retrospective, observational study, conducted in the French-speaking region of Switzerland, healthy women (= 207) who had had an IUB Ballerine MIDI inserted ≥12 months before enrolment, and their physicians completed questionnaires relating to device insertion, user experience and outcome. Questions relating to current menstrual patterns, physical comfort and product satisfaction were only posed to women still using the device. The mean age at insertion was 30.8 ± 7.2 years, with an average 14.2 ± 2.9 month lapse from time of insertion until study commencement. At the time of the study, 140 (67.6%) women were still using the device. The expulsion rate was 5.3% (= 11) and the pregnancy rate was 1.4% (= 3). Most of the women still using the device reported no to moderate pain or cramps (80.7%). The majority of women reported moderate to high (65.7%) satisfaction with the device, with 81.4% claiming they would recommend it to friends and relatives. Over 84.8% of physicians reported that the device was easy to insert, with no difficulties encountered during the procedure. The IUB Ballerine MIDI was demonstrated to be safe and acceptable in different clinical settings and risk groups among a socioeconomically and demographically diverse study population.
本研究的目的是利用从使用者和医生处收集的真实世界数据,评估宫内节育球(IUB)Ballerine MIDI铜宫内节育器(IUD)的可接受性。在这项于瑞士法语区进行的回顾性观察研究中,入组前已插入IUB Ballerine MIDI至少12个月的健康女性(=207名)及其医生完成了与器械插入、用户体验和结果相关的问卷。仅向仍在使用该器械的女性提出了与当前月经模式、身体舒适度和产品满意度相关的问题。插入时的平均年龄为30.8±7.2岁,从插入到研究开始的平均间隔时间为14.2±2.9个月。在研究时,140名(67.6%)女性仍在使用该器械。排出率为5.3%(=11名),妊娠率为1.4%(=3名)。大多数仍在使用该器械的女性报告无至中度疼痛或痉挛(80.7%)。大多数女性报告对该器械的满意度为中度至高(65.7%),81.4%的女性表示会向朋友和亲戚推荐。超过84.8%的医生报告称该器械易于插入,手术过程中未遇到困难。在一个社会经济和人口构成多样的研究人群中,IUB Ballerine MIDI在不同临床环境和风险组中被证明是安全且可接受的。