Evidence map›Paper›PMID 27881530›Full record

Trial reportBMJ open2016

Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya.

Penelope A Phillips-Howard, Elizabeth Nyothach, Feiko O Ter Kuile, Jackton Omoto, Duolao Wang, Clement Zeh, Clayton Onyango, Linda Mason, Kelly T Alexander, Frank O Odhiambo and 7 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 9 pooled it
8.2field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 9 syntheses or guidelines pooled it, 199 citations in OpenAlex.

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32 more citing papers are in PubMed but not listed here.

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

17 authors at 7 institutions in 3 countries.

Penelope A Phillips-HowardDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
Elizabeth NyothachCentre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Feiko O Ter KuileDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
Jackton OmotoSiaya District Hospital, Ministry of Health, Siaya, Kenya.
Duolao WangDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
Clement ZehCentre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Clayton OnyangoCentre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Linda MasonDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
Kelly T AlexanderDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
Frank O OdhiamboCentre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Alie EleveldSafe Water and AIDS Project (SWAP), Kisumu, Kenya.
Aisha MohammedDivision of Reproductive Health, Ministry of Public Health and Sanitation, Nairobi, Kenya.
Anna M van EijkDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
Rhiannon Tudor EdwardsCentre for Economics and Policy in Health, Bangor University, UK.
John VululeCentre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Brian FaragherDepartment of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
Kayla F LasersonCentre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Kenya Medical Research Institute · KELiverpool School of Tropical Medicine · GBCenters for Disease Control and Prevention · KEMinistry of Health · KEBangor University · GBCenters for Disease Control and Prevention · USSomalia Water and Land Information · KE

Funding

Medical Research Council G1100677Wellcome Trust
6 · The paper itself

Abstract

objectivesConduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes.

design3-arm single-site open cluster randomised controlled pilot study.

setting30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System.

participantsPrimary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area.

interventions1 insertable menstrual cup, or monthly sanitary pads, against 'usual practice' control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus.

resultsOf 751 girls enrolled 644 were followed-up for a median of 10.9 months. Cups or pads did not reduce school dropout risk (control=8.0%, cups=11.2%, pads=10.2%). Self-reported absence was rarely reported and not assessable. Prevalence of STIs in the end-of-study survey among controls was 7.7% versus 4.2% in the cups arm (adjusted prevalence ratio (aPR) 0.48, 0.24 to 0.96, p=0.039), 4.5% with pads (aPR=0.62; 0.37 to 1.03, p=0.063), and 4.3% with cups and pads pooled (aPR=0.54, 0.34 to 0.87, p=0.012). RTI prevalence was 21.5%, 28.5% and 26.9% among cup, pad and control arms, 71% of which were bacterial vaginosis, with a prevalence of 14.6%, 19.8% and 20.5%, per arm, respectively. Bacterial vaginosis was less prevalent in the cups (12.9%) compared with pads (20.3%, aPR=0.65, 0.44 to 0.97, p=0.034) and control (19.2%, aPR=0.67, 0.43 to 1.04, p=0.075) arm girls enrolled for 9 months or longer. No adverse events were identified.

conclusionsProvision of menstrual cups and sanitary pads for ∼1 school-year was associated with a lower STI risk, and cups with a lower bacterial vaginosis risk, but there was no association with school dropout. A large-scale trial on menstrual cups is warranted.

trial registrationISRCTN17486946; Results.

Indexed as

AbsenteeismAdolescentFeasibility StudiesFemaleHumansKenyaLinear ModelsMenstrual Hygiene ProductsMultivariate AnalysisPilot ProjectsReproductive Tract InfectionsRural PopulationSchoolsSexually Transmitted DiseasesStudent DropoutsStudentsadolescentmenstrual cupsmenstrual hygiene managementreproductive tract infectionssexual and reproductive healthsexually transmitted infections

Identifiers

PMID27881530
PMCPMC5168542
OpenAlexW2556685222

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.