{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:41:23Z","timestamp":1792798883083,"version":"4.5.0"},"reference-count":63,"publisher":"BMJ","issue":"4","funder":[{"name":"UK Medical Research Council\/Department for International Development\/Wellcome Trust (Joint Global Health) Trials award scheme","id":[{"id":"https:\/\/ror.org\/05rf29967","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,3,3]]},"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Observational studies nested in a cluster randomised controlled feasibility study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>30 primary schools in a health and demographic surveillance system in rural western Kenya.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Menstruating primary schoolgirls aged 14\u201316 years participating in a menstrual feasibility study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Insertable menstrual cup, monthly sanitary pads or \u2018usual practice\u2019 (controls).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome measures<\/jats:title>\n                    <jats:p>\n                      <jats:italic>Staphylococcus aureus<\/jats:italic>\n                      vaginal colonization,\n                      <jats:italic>Escherichia coli<\/jats:italic>\n                      growth on sampled used cups, toxic shock syndrome or other adverse health outcomes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up.\n                      <jats:italic>S. aureus<\/jats:italic>\n                      prevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65\u2009\n                      <jats:italic>S.aureus<\/jats:italic>\n                      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\n                      <jats:italic>E. coli<\/jats:italic>\n                      growth, 13 (37.1%, 95%\u2009CI 21.1% to 53.1%) had growth.\n                      <jats:italic>E. coli<\/jats:italic>\n                      growth was greatest in newer compared with established users (53%vs22.2%, p=0.12).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  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