In:
PLOS Medicine, Public Library of Science (PLoS), Vol. 20, No. 7 ( 2023-7-25), p. e1004258-
Abstract:
Nonhygienic products for managing menstruation are reported to cause reproductive tract infections. Menstrual cups are a potential solution. We assessed whether menstrual cups would reduce bacterial vaginosis (BV), vaginal microbiome (VMB), and sexually transmitted infections (STIs) as studies have not evaluated this. Methods and findings A cluster randomized controlled trial was performed in 96 Kenyan secondary schools, randomized (1:1:1:1) to control, menstrual cup, cash transfer, or menstrual cup plus cash transfer. This substudy assessing the impact of menstrual cups on BV, VMB, and STIs, included 6 schools from the control (3) and menstrual cup only (3) groups, both receiving BV and STI testing and treatment at each visit. Self-collected vaginal swabs were used to measure VMB (16S rRNA gene amplicon sequencing), BV (Nugent score), and STIs. STIs were a composite of Chlamydia trachomatis and Neisseria gonorrhoeae (nucleic acid amplification test) and Trichomonas vaginalis (rapid immunochromatographic assay). Participants were not masked and were followed for 30 months. The primary outcome was diagnosis of BV; secondary outcomes were VMB and STIs. Intention-to-treat blinded analyses used mixed effects generalized linear regressions, with random effects term for school. The study was conducted between May 2, 2018, and February 7, 2021. A total of 436 participants were included: 213 cup, 223 control. There were 289 BV diagnoses: 162 among control participants and 127 among intervention participants (odds ratio 0.76 [95% CI 0.59 to 0.98]; p = 0.038). The occurrence of Lactobacillus crispatus– dominated VMB was higher among cup group participants (odds ratio 1.37 [95% CI 1.06 to 1.75]), as was the mean relative abundance of L . crispatus (3.95% [95% CI 1.92 to 5.99]). There was no effect of intervention on STIs (relative risk 0.82 [95% CI 0.50 to 1.35] ). The primary limitations of this study were insufficient power for subgroup analyses, and generalizability of findings to nonschool and other global settings. Conclusions Menstrual cups with BV and STI testing and treatment benefitted adolescent schoolgirls through lower occurrence of BV and higher L . crispatus compared with only BV and STI testing and treatment during the 30 months of a cluster randomized menstrual cup intervention. Trial registration ClinicalTrials.gov NCT03051789 .
Type of Medium:
Online Resource
ISSN:
1549-1676
DOI:
10.1371/journal.pmed.1004258
DOI:
10.1371/journal.pmed.1004258.g001
DOI:
10.1371/journal.pmed.1004258.g002
DOI:
10.1371/journal.pmed.1004258.g003
DOI:
10.1371/journal.pmed.1004258.t001
DOI:
10.1371/journal.pmed.1004258.t002
DOI:
10.1371/journal.pmed.1004258.t003
DOI:
10.1371/journal.pmed.1004258.t004
DOI:
10.1371/journal.pmed.1004258.s001
DOI:
10.1371/journal.pmed.1004258.s002
DOI:
10.1371/journal.pmed.1004258.s003
DOI:
10.1371/journal.pmed.1004258.s004
DOI:
10.1371/journal.pmed.1004258.s005
DOI:
10.1371/journal.pmed.1004258.s006
DOI:
10.1371/journal.pmed.1004258.s007
DOI:
10.1371/journal.pmed.1004258.s008
DOI:
10.1371/journal.pmed.1004258.r001
DOI:
10.1371/journal.pmed.1004258.r002
DOI:
10.1371/journal.pmed.1004258.r003
DOI:
10.1371/journal.pmed.1004258.r004
DOI:
10.1371/journal.pmed.1004258.r005
DOI:
10.1371/journal.pmed.1004258.r006
DOI:
10.1371/journal.pmed.1004258.r007
DOI:
10.1371/journal.pmed.1004258.r008
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2023
detail.hit.zdb_id:
2164823-2
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