Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
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DOI：
10.1136/bmjopen-2016-015429
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发表时间：
2017-04-01
期刊：
影响因子：
2.9
通讯作者：
Phillips-Howard, Penelope A.
中科院分区：
文献类型：
--
作者：
Juma, Jane;Nyothach, Elizabeth;Phillips-Howard, Penelope A.
Objective examination the safety of menstrual cups against sanitary pads and usual practice in Kenya schoolgirls.Design Observational studies nested in a cluster randomized controlled practical study. Set 30 primary schools in a health and demographic surveillance system in rural western Kenya.Participants Menstruating primary schoolgirls aged 14-16 years participating in a menstrual practical study. Interventions Insertable menstrual cup，monthly sanitary pads or“usual practice”（controls.Outcome measures Staphylococcus aureus vaginal colonization，Escherichia coli growth on samples used cups，toxic shock syndrome or other adverse health outcomes.Results在604名合格的女孩中进行测试，在中位数为10.9个月的随访中，未检测到不良事件或TSS。S. aureus患病率为10.8%，在干预时间内或组间无显著差异。65 S.首次检测金黄色葡萄球菌阳性的49名女孩进行了复检，10名（20.4%）仍为阳性。其中，两个（20%）样本分离株中毒性休克综合征毒素-1检测呈阳性;两个女孩都提供了垫，临床健康。7%的杯子因丢失、损坏、掉在厕所里或不合适而需要更换。对30个旧杯子进行E.大肠杆菌生长，13株（37.1%，95%CI 21.1%~ 53.1%）有生长。E.与已有使用者相比，新使用者的大肠杆菌生长最大（53%比22.2%，p=0.12）。结论在该可行性样本中，没有证据表明月经杯对肯尼亚农村女学生有害或造成健康损害，但大规模试验和上市后监测应继续评估月经杯的安全性。
Objective Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls.Design Observational studies nested in a cluster randomised controlled feasibility study.Setting 30 primary schools in a health and demographic surveillance system in rural western Kenya.Participants Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study. Interventions Insertable menstrual cup, monthly sanitary pads or 'usual practice' (controls).Outcome measures Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes.Results Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureusprevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65 S. aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12).Conclusions Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety.