Evidence map›Paper›PMID 28473520›Full record

Observational studyBMJ open2017

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

Jane Juma, Elizabeth Nyothach, Kayla F Laserson, Clifford Oduor, Lilian Arita, Caroline Ouma, Kelvin Oruko, Jackton Omoto, Linda Mason, Kelly T Alexander and 3 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05444504 (Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05444504 narecruitingnot on this mapstarted 2023, after this paper: background citation

Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2023 to 2026Enrolled100ConditionsObstetric Fistula, Fistula, Fistula, Urinary, Fistula, VaginalArmsCup, Cup+
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
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  7. Article
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  9. The Vaginal Microbiome and Reproductive Health in Adolescents and Adults.Journal of pediatric and adolescent gynecology · 2025
    Review
  10. Article
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  16. In Vitro Study to Assess Effective Cleaning Techniques for RemovingInternational journal of environmental research and public health · 2022
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 3 countries.

Jane JumaCenter for Global Health, Kenya Medical Research Institute, Kisumu, Kenya.
Elizabeth NyothachCenter for Global Health, Kenya Medical Research Institute, Kisumu, Kenya.
Kayla F LasersonCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Clifford OduorCenter for Global Health, Kenya Medical Research Institute, Kisumu, Kenya.
Lilian AritaCenter for Global Health, Kenya Medical Research Institute, Kisumu, Kenya.
Caroline OumaCenter for Global Health, Kenya Medical Research Institute, Kisumu, Kenya.
Kelvin OrukoCenter for Global Health, Kenya Medical Research Institute, Kisumu, Kenya.
Jackton OmotoSiaya District Hospital, Ministry of Health, Siaya, Kenya.
Linda MasonLiverpool School of Tropical Medicine, Liverpool, UK.
Kelly T AlexanderLiverpool School of Tropical Medicine, Liverpool, UK.
Barry FieldsCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Clayton OnyangoCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Penelope A Phillips-HowardDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Kenya Medical Research Institute · KECenters for Disease Control and Prevention · USLiverpool School of Tropical Medicine · GBMinistry of Health · KE

Funding

Medical Research Council G1100677/1Wellcome Trust
6 · The paper itself

Abstract

objectiveExamine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls.

designObservational studies nested in a cluster randomised controlled feasibility study.

setting30 primary schools in a health and demographic surveillance system in rural western Kenya.

participantsMenstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study.

interventionsInsertable menstrual cup, monthly sanitary pads or 'usual practice' (controls). OUTCOME MEASURES:

resultsAmong 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up.

conclusionsAmong 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.

Indexed as

Menstrual Hygiene ProductsSchoolsStudentsAdolescentEscherichia coli InfectionsFeasibility StudiesFemaleHealth Knowledge, Attitudes, PracticeHumansKenyaRandomized Controlled Trials as TopicReproductive Tract InfectionsRural PopulationStaphylococcal InfectionsVaginosis, BacterialEscherichia colihygieneKenyamenstrual cupsmenstrual hygiene managementStaphylococcus aureustoxic shock syndrome

Identifiers

PMID28473520
PMCPMC5566618
OpenAlexW2610163080

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.