Menstrual Solutions Study

Not Applicable

Completed

• Conditions: School, social, and health outcomes associated with menstrual hygiene management in schoolgirls; Not Applicable

• Registration Number: ISRCTN17486946
• Lead Sponsor: Kenya Medical Research Institute

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26819339 results on Prevalence of reproductive tract infections and the predictive value of girls' symptom-based reporting 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27881530 results on Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36185073/ (added 04/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-04-01
• Study Start: 2014-12-16
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

1. Primary school girls, in classes 5 upwards
2. Attend a study school
3. Reached menarche, experienced a minimum of three menses
4. Are aged 14-16 years at enrolment
5. Resident in the health and demographic surveillance system study area
6. Parents/guardian provided written informed consent
7. Participating girl provided written informed assent

Exclusion Criteria

1. Not attending primary school, or below class 5
2. Not reached menarche or experienced minimum of 3 menses
3. Are outside the study age (14-16 years at enrolment)
4. Not resident in health and demographic surveillance system study area
5. Do not attends one of the study schools
6. Parent/guardian refused informed consent
7. Participant refused informed assent
8. Participant declares presence of an intrauterine device;
9. Participants has a severe physical / learning disability preventing informed consent or ability to participate
10. Participant has suffered from toxic shock syndrome;
11. Participant is pregnant pre-intervention (determined through observed/declared pregnancy, and birth; not through pregnancy testing)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Prevalence of cumulative school attrition over one school year per arm: Nurse screening of all participants twice termly identified girls missing from school. Using geo-location data from health and demographic surveillance system, field staff (village reporters) visited homes to confirm if participants had dropped-out of school, and reasons for this, or if drop-out was due to migration out of the study area, or transfer to another school. Data capture has been throughout study, with endpoint confirmation through household visits to all homes of participants in 2014.<br> Absence from school (note absenteeism is difficult to measure, so different methods adopted to determine which generates precision data): collected from monthly menstrual calendars provided to participants, from school registries compared against twice termly unannounced school visit headcounts, and girls separate private screening surveys.<br>