Montgomery Elizabeth T, Blanchard Kelly, Cheng Helen, Chipato Tsungai, de Bruyn Guy, Ramjee Gita, Padian Nancy, van der Straten Ariane
Women's Global Health Imperative, RTI International, San Francisco Project Office, San Francisco, CA 94104, USA.
Eur J Contracept Reprod Health Care. 2009 Dec;14(6):410-9. doi: 10.3109/13625180903215430.
We examined diaphragm and gel-related skills, patterns of use, and problems, among women who participated in the MIRA study, a multisite phase III diaphragm trial in Zimbabwe and South Africa.
We evaluated whether baseline characteristics were associated with the ability to correctly insert/remove the diaphragm prior to randomisation by means of multivariate logistic regression modeling. Employing face-to-face interviews with intervention arm participants, patterns of use and comfort using the products were measured at Month 3 and Exit, and reported problems with the products were assessed quarterly.
At baseline, 72.5% of women correctly inserted/removed the diaphragm within one attempt, and this skill was most strongly associated with the Johannesburg study site. At exit, over 90% of intervention women were very comfortable inserting, wearing, cleaning and removing the diaphragm; however, 31.8% reported usual removal of the diaphragm before the prescribed six hours after sex. During the 12-24 month follow-up period there were only 133 (<1%) reported problems with the diaphragm and gel over 14,544 follow-up visits.
Diaphragm skills were easily acquired and few problems were reported during the course of the trial. Reviving the diaphragm as a contraceptive option or as a reusable microbicide delivery mechanism seems feasible in these settings.
我们在参与MIRA研究的女性中调查了子宫帽及凝胶相关技能、使用模式和问题。MIRA研究是在津巴布韦和南非开展的一项多中心III期子宫帽试验。
我们通过多变量逻辑回归模型评估了随机分组前基线特征是否与正确插入/取出子宫帽的能力相关。通过对干预组参与者进行面对面访谈，在第3个月和研究结束时测量了产品的使用模式和舒适度，并每季度评估报告的产品问题。
在基线时，72.5%的女性在一次尝试中就能正确插入/取出子宫帽，这项技能与约翰内斯堡研究地点的关联最为紧密。在研究结束时，超过90%的干预组女性在插入、佩戴、清洁和取出子宫帽时非常舒适；然而，31.8%的女性报告在性行为后规定的6小时之前就通常会取出子宫帽。在12 - 24个月的随访期内，在14544次随访中，仅报告了133例（<1%）与子宫帽和凝胶有关的问题。
子宫帽技能很容易掌握，并且在试验过程中报告的问题很少。在这些环境中将子宫帽作为一种避孕选择或作为一种可重复使用的杀微生物剂递送机制恢复使用似乎是可行的。
