Acceptability and Performance of the Menstrual Cup in South Africa: A Randomized Crossover Trial Comparing the Menstrual Cup to Tampons or Sanitary Pads
Acceptability and Performance of the Menstrual Cup in South Africa: A Randomized Crossover Trial Comparing the Menstrual Cup to Tampons or Sanitary Pads
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DOI：
10.1089/jwh.2014.5021
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发表时间：
2015-02-01
影响因子：
3.5
通讯作者：
Hoffmann, Vivian
中科院分区：
文献类型：
--
作者：
Beksinska, Mags E.;Smit, Jenni;Hoffmann, Vivian
背景：在低收入环境中，由于缺乏负担得起的月经产品，许多妇女和女孩在月经期间面临活动限制。月经杯（MC）是一种可重复使用的非吸收性杯子，用于收集经血。我们评估的可接受性和性能的MPower（（R））MC相比，垫或卫生棉条中的妇女在一个低resource setting.Methods：我们进行了一个随机的两个阶段的交叉试验，在一个网站在德班，南非，2013年1月至11月。年龄在18-45岁之间，月经周期正常的参与者如果不打算怀孕，正在使用有效的避孕方法，将市政系统的水作为主要水源，并且没有性传播感染，则有资格入选。我们使用计算机生成的随机序列将参与者分配到两个月经产品使用序列中的一个，仅对研究人员隐藏分配。参与者在三个月经周期（总共6个月）内使用每种方法，并在基线和每月随访时接受采访。产品可接受性结果使用具有个体随机效应的有序逻辑回归模型比较产品满意度问题分数。该研究在南非临床试验数据库中注册：编号DOH-27- 01134273。结果：在评估的124名妇女中，110名合格，并随机分配到选定的月经产品。105名妇女完成了所有随访。通过与垫/棉塞（常用产品）相比，MC在舒适度、质量、经血收集、外观和偏好方面被评为明显更好。这两个比较结果的措施，沿着继续使用的可能性，推荐的产品，和未来的购买，增加了MC随着时间的推移。结论：MC接受在人口的新手用户，许多经验有限的卫生棉条，表明有一个池的潜在用户在低资源设置。
Background: In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower((R)) MC compared to pads or tampons among women in a low-resource setting.Methods: We conducted a randomized two-period crossover trial at one site in Durban, South Africa, between January and November 2013. Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant, were using an effective contraceptive method, had water from the municipal system as their primary water source, and had no sexually transmitted infections. We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use, with allocation concealed only from the study investigators. Participants used each method over three menstrual cycles (total 6 months) and were interviewed at baseline and monthly follow-up visits. The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects. This study is registered on the South African Clinical Trials database: number DOH-27-01134273.Results: Of 124 women assessed, 110 were eligible and randomly assigned to selected menstrual products. One hundred and five women completed all follow-up visits. By comparison to pads/tampons (usual product used), the MC was rated significantly better for comfort, quality, menstrual blood collection, appearance, and preference. Both of these comparative outcome measures, along with likelihood of continued use, recommending the product, and future purchase, increased for the MC over time.Conclusion: MC acceptance in a population of novice users, many with limited experience with tampons, indicates that there is a pool of potential users in low-resource settings.