Baram Ilan, Aharon Arnon, Klein Rinat, Shkolnik Ketty
Maccabi Healthcare Services, Modiin, Israel.
OCON Healthcare, Clinical Development, Modiin, Israel.
Eur J Contracept Reprod Health Care. 2020 Feb;25(1):49-53. doi: 10.1080/13625187.2019.1699048. Epub 2019 Dec 18.
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 Israel. In this retrospective, observational study, conducted in a single clinic in Israel, healthy women ( = 175) who had had the device inserted ≥12 months prior to enrolment, and their physician, completed questionnaires relating to device insertion, user experience and performance. The mean age at insertion was 32.8 ± 6.7 years; most women were married (80.6%) and multigravid (89.1%). At the time of the study, 131 (74.9%) women were still using the device; in 13 cases (7.4%), premature removal was due to desire to conceive. The 12 month continuation rate, excluding the women seeking to conceive, was 90.1%. The expulsion rate was 3.4% ( = 6) and the pregnancy rate was 0.57% ( = 1). Most of the women still using the device reported no to moderate pain or cramps (90.0%) and moderate to high (72.6%) satisfaction with the device; 76.3% said they would recommend it to friends and relatives. Most of the insertion procedures (86.9%) were uneventful and none required cervical dilation. The IUB Ballerine MIDI raised no major safety concerns and was both effective and highly accepted in a cohort of women, covering a broad age range, treated in a gynaecology clinic in Israel.
本研究的目的是利用从以色列的使用者和医生那里收集的真实世界数据,评估宫腔球(IUB)Ballerine MIDI铜宫内节育器(IUD)的可接受性。在以色列一家诊所进行的这项回顾性观察研究中,入组前已插入该装置≥12个月的健康女性(n = 175)及其医生完成了与装置插入、用户体验和性能相关的问卷。插入时的平均年龄为32.8±6.7岁;大多数女性已婚(80.6%)且为多产妇(89.1%)。在研究时,131名(74.9%)女性仍在使用该装置;13例(7.4%)过早取出是因为有怀孕意愿。排除寻求怀孕的女性后,12个月的持续使用率为90.1%。脱落率为3.4%(n = 6),妊娠率为0.57%(n = 1)。大多数仍在使用该装置的女性报告疼痛或痉挛不明显或为中度(90.0%),对该装置的满意度为中度至高(72.6%);76.3%的女性表示会向朋友和亲戚推荐。大多数插入操作(86.9%)顺利,无一例需要宫颈扩张。IUB Ballerine MIDI未引起重大安全问题,在以色列一家妇科诊所接受治疗的、年龄范围广泛的女性队列中,该装置既有效又高度被接受。