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Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study

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 Keny...

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Autores principales: Juma, Jane, Nyothach, Elizabeth, Laserson, Kayla F, Oduor, Clifford, Arita, Lilian, Ouma, Caroline, Oruko, Kelvin, Omoto, Jackton, Mason, Linda, Alexander, Kelly T, Fields, Barry, Onyango, Clayton, Phillips-Howard, Penelope A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Open 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5566618/
https://www.ncbi.nlm.nih.gov/pubmed/28473520
http://dx.doi.org/10.1136/bmjopen-2016-015429
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author Juma, Jane
Nyothach, Elizabeth
Laserson, Kayla F
Oduor, Clifford
Arita, Lilian
Ouma, Caroline
Oruko, Kelvin
Omoto, Jackton
Mason, Linda
Alexander, Kelly T
Fields, Barry
Onyango, Clayton
Phillips-Howard, Penelope A
author_facet Juma, Jane
Nyothach, Elizabeth
Laserson, Kayla F
Oduor, Clifford
Arita, Lilian
Ouma, Caroline
Oruko, Kelvin
Omoto, Jackton
Mason, Linda
Alexander, Kelly T
Fields, Barry
Onyango, Clayton
Phillips-Howard, Penelope A
author_sort Juma, Jane
collection PubMed
description 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.
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spelling pubmed-55666182017-08-28 Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study Juma, Jane Nyothach, Elizabeth Laserson, Kayla F Oduor, Clifford Arita, Lilian Ouma, Caroline Oruko, Kelvin Omoto, Jackton Mason, Linda Alexander, Kelly T Fields, Barry Onyango, Clayton Phillips-Howard, Penelope A BMJ Open Public Health 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. BMJ Open 2017-05-04 /pmc/articles/PMC5566618/ /pubmed/28473520 http://dx.doi.org/10.1136/bmjopen-2016-015429 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
spellingShingle Public Health
Juma, Jane
Nyothach, Elizabeth
Laserson, Kayla F
Oduor, Clifford
Arita, Lilian
Ouma, Caroline
Oruko, Kelvin
Omoto, Jackton
Mason, Linda
Alexander, Kelly T
Fields, Barry
Onyango, Clayton
Phillips-Howard, Penelope A
Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
title Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
title_full Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
title_fullStr Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
title_full_unstemmed Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
title_short Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study
title_sort examining the safety of menstrual cups among rural primary school girls in western kenya: observational studies nested in a randomised controlled feasibility study
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5566618/
https://www.ncbi.nlm.nih.gov/pubmed/28473520
http://dx.doi.org/10.1136/bmjopen-2016-015429
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