Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201202000361337 Date of Approval: 14/02/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sanitary Pads for Girls' Education in Africa
Official scientific title Sanitary Pad Interventions for Girls Education in Africa: A controlled study
Brief summary describing the background and objectives of the trial Increased education of girls in developing contexts is associated with a number of important positive health, social and economic outcomes for a community. The event of menarche tends to coincide with girls transitions from primary to secondary education and may constitute a barrier for continued school attendance and performance. A controlled study was conducted in Ghana to assess the role of sanitary pads in girls education.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Menstruation and school attendance in healthy Ghanian girls
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2008
Actual trial start date 31/08/2009
Anticipated date of last follow up 29/10/2009
Actual Last follow-up date 30/10/2009
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rural pads and education 5 months Provision of pads with puberty education in a rural setting 21
Experimental Group Periurban pads and education 5 months Provision of pads with puberty education in a periurban setting 39
Experimental Group Periruban education alone 5 months Puberty education alone in periurban setting 25
Control Group Control group 5 months control - no pads or education provided 35 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy menstruating girls aged 12 - 18 Pre-menarcheal girls were exlcuded 12 Year(s) 18 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/09/2008 Ghana Health Service Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Private Mail Bag, Ministries, Accra. Accra Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Teacher reported attendance. Researchers compared official attendance data with actual student attendance data at every site Month 1 Month 3 Month 5
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CARE Guld of Guinea, Kumasi Sub Office PO BOx AS 18, Asawase Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Oxford University John Fell Fund University Offices, Wellington Square Oxford OX12JD United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oxford University University Offices, Wellington Square Oxford OX12JD United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Not Applicable
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Montgomery paul.montgomery@spi.ox.ac.uk 01865 270325 Barnett House, 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Professor, Centre for Evidence Based Intervention
Role Name Email Phone Street address
Public Enquiries Linda Scott linda.scott@sbs.ox.ac.uk +44 (0)1865 288800 Said Business School, Univeristy of Oxford, Park End Street
City Postal code Country Position/Affiliation
Oxford OX1 1HP United Kingdom Professor
Role Name Email Phone Street address
Scientific Enquiries Paul Montgomery paul.montgomery@spi.ox.ac.uk 01865 270325 Barnett House, 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Professor, Centre for Evidence Based Intervention
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information