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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: www.pactr.org

Trial no.: PACTR201202000361337 Date registered: 2012/02/14
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 Others
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Education/Counselling/Training
Anticipated trial start date 2008-09-01
Actual trial start date 2009-08-31
Anticipated date of last follow up
Actual date of last follow up 2009-10-30
Anticipated target sample size (number of participants) 120   
Actual target sample size (number of participants) 120   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 Min age Max age Gender
Healthy menstruating girls aged 12 - 18 Pre-menarcheal girls were exlcuded 12 Years 18 Years 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 2008/09/01 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 Fax
Principal Investigator Prof Paul Montgomery paul.montgomery@ spi.ox.ac.uk 01865 270325 01865 270324
Street address City Postal code Country Position / Affiliation
Barnett House, 32 Wellington Square Oxford OX1 2ER United Kingdom Professor, Centre for Evidence Based Intervention
Role Name Email Phone Fax
Scientific Enquiries Prof Paul Montgomery paul.montgomery@ spi.ox.ac.uk 01865 270325 01865 270324
Street address City Postal code Country Position / Affiliation
Barnett House, 32 Wellington Square Oxford OX1 2ER United Kingdom Professor, Centre for Evidence Based Intervention
Role Name Email Phone Fax
Public Enquiries Prof Linda Scott linda.scott@sbs.ox.ac.uk +44 (0)1865 288800
Street address City Postal code Country Position / Affiliation
Said Business School, Univeristy of Oxford, Park End Street Oxford OX1 1HP United Kingdom Professor