Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Juma J

PROVIDER: S-EPMC5566618 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 J Nyothach Elizabeth E Laserson Kayla F KF Oduor Clifford C Arita Lilian L Ouma Caroline C Oruko Kelvin K Omoto Jackton J Mason Linda L Alexander Kelly T KT Fields Barry B Onyango Clayton C Phillips-Howard Penelope A PA

BMJ open 20170504 4

<h4>Objective</h4>Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls.<h4>Design</h4>Observational studies nested in a cluster randomised controlled feasibility study.<h4>Setting</h4>30 primary schools in a health and demographic surveillance system in rural western Kenya.<h4>Participants</h4>Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study.<h4>Interventions</h4>Insertable menstrual cup, monthly sanit ...[more]

PMID: 28473520

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Project description:BackgroundHigh rates of sexual and reproductive health (SRH) harms and interrupted schooling are global challenges for adolescent girls, requiring effective interventions. We assessed the impact of menstrual cups (MCs) or cash transfers conditioned on school attendance (CCTs), or both, on SRH and schooling outcomes in western Kenya.MethodsIn this cluster-randomised Cups or Cash for Girls (CCG) trial, adolescent girls in Forms two and three at 96 secondary schools in Siaya County (western Kenya) were randomised to receive either CCT, MC, combined CCT and MC, or control (1:1:1:1) for an average of 30 months. The CCT intervention comprised 1500KES (US$15 in 2016) via a cash card each school trimester. All four treatment groups received puberty and hygiene training. Assenting girls with parent or guardian consent who were post-menarche, not pregnant, area residents, not boarding, and had no disabilities precluding participation were eligible. Socio-behavioural risk factors and incidence of HIV and herpes simplex virus type 2 (HSV-2) were measured annually. School retainment and adverse events were monitored throughout. The primary outcome comprised a composite of incident HIV, HSV-2 and/or all-cause school dropout by school exit examination. The primary analysis was by intention-to-treat (ITT) using generalised linear mixed models, controlling for a priori selected baseline covariates. The trial is registered with ClinicalTrials.gov, NCT03051789.FindingsBetween February 28, 2017 and June 30, 2021, 4137 girls (median age 17.1 [interquartile range (IQR): 16.3-18.0]) were enrolled and followed annually until completion of secondary school (median 2.5 years [IQR: 2.4-2.7]); 4106 (99.3%) contributed to the ITT analysis. No differences in the primary composite outcome between intervention and control groups were seen (MC: 18.2%, CCT: 22.1%, combined: 22.1%, control: 19.6%; adjusted risk ratio [aRR]: 0.97, 95% confidence interval 0.76-1.24; 1.14, 0.90-1.45; and 1.13, 0.90-1.43, respectively). Incident HSV-2 occurred in 8.6%, 13.3%, 14.8%, and 12% of the MC, CCT, combined and control groups, respectively (MC: RR: 0.67, 0.47-0.95, p = 0.027; aRR: 0.71, 0.50-1.01, p = 0.057; CCT: aRR: 1.02, 0.73-1.41, p = 0.92; combined aRR: 1.16, 0.85-2.58, p = 0.36). Incident HIV was low (MC: 1.2%, CCT: 1.5%, combined: 1.0%, and control: 1.4%; aRR: 0.88, 0.38-2.05, p = 0.77, aRR: 1.16, 0.51-2.62, p = 0.72, aRR: 0.80, 0.33-1.94, p = 0.62, respectively). No intervention decreased school dropout (MC: 11.2%, CCT: 12.4%, combined: 10.9%, control: 10.5%; aRR: 1.16, 0.86-1.57; 1.23, 0.91-1.65; and 1.06, 0.78-1.44, respectively). No related serious adverse events were seen.InterpretationMCs, CCTs, or both, did not protect schoolgirls against a composite of deleterious harms. MCs appear protective against HSV-2. Studies of longer follow-up duration with objective measures of health impact are needed in this population.FundingDepartment of Health and Social Care, the Foreign, Commonwealth & Development Office, the Medical Research Council and Wellcome.

Project description:BackgroundAdolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances.MethodsSingle site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout.DiscussionIf proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries.Trial registrationClinicalTrials.gov NCT03051789 , 15th February 2017.

Project description:BackgroundWomen in rural settings particularly in schools suffer more from stigma and lack of services and facilities during menstruation. However, the issue has not received proper attention from school water sanitation and hygiene programs. And this study was aimed to identify knowledge and practice of menstrual hygiene, and associated factors.MethodInstitution based cross-sectional study was employed among 441 school girls in Mekidela city. EpiData Version 4.6 and the Statistical Package for the Social Sciences Version 25.0 were used for data entry and analysis, respectively. Bivariable and multivariable logistic regression was employed to identify factors associated with the outcome variables. Variables with a p-value<0.25 in the bivariable analysis were a candidate for multivariable logistic regression and p-value<0.05 in the multivariable analysis was used to declare significant association.ResultsOf the respondents, 64.9% reported good knowledge of menstrual hygiene management. In multivariable analysis; grade level (grade 11 & 12) [adjusted odds ratio (AOR) = 2.23, 95% C.I (1.19-4.16)], age ≥ 19 years [AOR = 3.45, 95% C.I (1.78-6.69)], residence [AOR = 1.90, 95% C.I: (1.12-3.23)], know sanitary pads [AOR = 2.67, 95% CI: (1.19-6.00)] and learned about menstrual hygiene [AOR = 1.71, 95% CI: (1.02-2.87)] found to be associated with knowledge. About 62.4% have good menstrual hygiene practices. Knowledge on menstrual hygiene [AOR = 1.73, 95% C.I (1.07-2.80)], know about reproductive tract/sexually transmitted infections [AOR = 2.46, 95% CI: (1.37-4.43)], having private shower [AOR = 2.04, 95% C.I 2.04(1.24-3.37)] and residence [AOR = 3.76, 95% C.I:(2.18-6.51)] were factors associated with practice.ConclusionOverall nearly two-third of respondents had good knowledge and good practice of menstrual hygiene management. Factors significantly associated with their knowledge included age, grade level, residence, learning on menstrual hygiene, and knowledge of sanitary pads. Residence, knowledge on menstrual hygiene, know about sexually transmitted infections and having a private shower were found to be associated with practice of menstrual hygiene management. In general, our finding indicates that menstrual hygiene was unsatisfactory among adolescent school girls and more should be done on the factors identified.

Project description:BACKGROUND:Menstrual exile, also known as Chhaupadi, is a tradition of "untouchability" in far-western Nepal. Forbidden from touching other people and objects, women and girls are required to live away from the community, typically in a livestock shed, during menstruation. We assessed the lived experiences of Chhaupadi among Nepalese adolescent girls in the far-western Achham district of Nepal, observed the safety and sanitation of their living spaces during Chhaupadi, and assessed the perceptions of local adult stakeholders towards the practice of Chhaupadi. METHODS:We collected data from 107 adolescent girls using a self-administered survey in two local schools in Achham. We also conducted a focus group discussion with seven girls, held key informant interviews, and observed the girls' living spaces during Chhaupadi, using a checklist. Descriptive statistics of the quantitative survey and thematic analyses of qualitative interviews are presented. RESULTS:The majority of the girls (n = 77, 72%) practiced exile, or Chhaupadi, during their menstruation, including 3 (4%) exiled to traditional Chhau sheds, 63 (82%) to livestock sheds, and 11 (14%) to courtyards outside their home. The remaining girls (n = 30, 28%) stayed inside the house, yet practiced some form of menstrual taboos. Of the 77 observed living spaces where the girls stayed during exile, only 30% (n = 23) had a toilet facility. Most exiled girls (97.4%) were restricted from eating dairy products. Participants reported having various psychological problems, including lonliness and difficulty sleeping while practicing Chhaupadi. Three of the girls were physically abused; nine were bitten by a snake. Notably high proportions of the living spaces lacked ventilation/windows (n = 20, 26%), electricity (n = 29, 38%), toilets (n = 54, 70%) and a warm blanket and mattress for sleeping (n = 29, 38%). Our qualitative findings supported our quantitative results. CONCLUSIONS:Chhaupadi has been condemned by human rights organizations. While the government has banned the practice, implementation on the ban is proceeding slowly, especially in far-western Nepal. Thus, as a temporary measure, public health professionals must work towards promoting the health and safety of Nepalese women and girls still practicing Chhaupadi.

Project description:BACKGROUND:Menstruation is a normal physiological process of females at their reproductive age. However, it is surrounded with social taboos and supernatural beliefs. The poor knowledge and understanding of menstruation may lead to unsafe hygienic practice that intern increases the risk of reproductive and genito-urinary tract infections, cervical cancer, school drop-out, poor academic performance and overall poor quality of life. Despite such clinical and academic effects, the knowledge and hygienic practice of adolescent girls towards menstruation is not well addressed in Ethiopia, particularly among school adolescent girls. Therefore, the main objective of this study was to assess the knowledge and menstrual hygiene practice among adolescent school girls in southern Ethiopia. METHODS:This was an institutional based cross-sectional study conducted at Gedeo zone high schools among 791 randomly selected adolescent girls using multi stage sampling technique. Data were collected using interviewer administered questionnaire. The collected data were entered to EPI-INFO (soft ware) and exported to SPSS version 20 for analysis. Bivariable and multivariable logistics analyses were computed to identify factors associated with the poor menstrual hygienic practice. During bi-variable analysis, variables with P-values of less than 0.25 were entered to multivariable model for further analysis. In the final model, P-value of less than 0.05 was used as a base to identify factors having a statistically significant association with poor menstrual hygiene practice at corresponding 95% confidence interval. RESULT:From a total of 791 adolescent girls participated in this study, 68.3% had poor knowledge of menstruation. About 48.1% of school girls used absorbent materials, and 69.5% clean their external genitalia. Generally, 60.3% of girls had poor menstrual hygienic practice. Age less than 15?years [OR?=?1.71:95% CI (1.22, 2.39)], longer days of menstrual flow [OR?=?2.51:95% CI (1.66, 3.80)] and poor knowledge of menses [OR?=?1.48:95% CI (1.04, 2.1)] had a significantly associated with poor menstrual hygiene practice. CONCLUSION:Majority of adolescent school girls had poor knowledge regarding menstruation and their hygienic practices are incorrect. This demonstrates a need to design acceptable awareness creation and advocacy programs to improve the knowledge and promote safe hygienic practice of adolescent school girls during menstruation.

Dataset Information

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

Objective

Design

Setting

Participants

Interventions

Outcome measures

Results

Conclusions

Publications

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

Similar Datasets

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