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.: PACTR201109000315313 Date of Approval: 25/08/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The C-MaMiE birth cohort: evaluating the impact of access to free health care on child and maternal outcomes in Ethiopia
Official scientific title The C-MaMiE birth cohort (Child health in relation to Maternal Mental health in Ethiopia): evaluating the impact of access to free health care on child and maternal outcomes in Ethiopia
Brief summary describing the background and objectives of the trial The Child outcomes-Maternal Mental Disorder in Ethiopia (¿C-MaMiE¿) study provides an opportunity for quasi-experimental evaluation of the impact of relieving health service costs for child/mother pairs in rural Ethiopia over an extended period of time. Mothers and their children participating in the C-MaMiE birth cohort have received free healthcare at the point of use for the majority of the project duration as a condition of the Ethical Review committee in Ethiopia. Primary hypothesis Making health services free at the point of use in the C-MaMiE cohort will result in: 1. Reduction in the prevalence of child stunting at six and a half years of age (detectable reduction from expected 51% to 44.8% prevalence). 2. Reduction in cumulative child mortality at six and a half years (detectable reduction from expected 123/1000 to 91/1000 live births).
Type of trial CCT
Acronym (If the trial has an acronym then please provide) C MaMiE
Disease(s) or condition(s) being studied Child undernutrition, child survival, maternal mental health, child mental health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 22/08/2011
Actual trial start date
Anticipated date of last follow up 01/03/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 2400
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
PNM/10/11-38 KCL Ethics Committee ID number
093559 Wellcome Trust Grant number
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 Not Applicable Not Applicable Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Free health care for women and their index child participating in the C-MaMiE birth cohort study Out-of-pocket expenses for health facility fees, including registration, investigations and medication, but excluding transport to the health facility. Free healthcare when the children were aged from 0 to 1.5 years (approx. July 2005-March 2006) and from age 2.5 years to 6.5 years). Free healthcare provided for mothers and their index child enrolled in the C-MaMiE project. 1065
Control Group No Free Health Care Standard care 0 to 1.5 years and 2.5 to 6.5 years Standard care at full cost to the mother and child pair 2130 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged 15 to 49 years of age and in the third trimester of pregnancy at the time of recruitment, able to be interviewed in Amharic, and residing in the Butajira demographic surveillance site. Severe mental illness. 15 Year(s) 49 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 16/06/2011 National Research Ethics Review Committee, Ethiopia
Ethics Committee Address
Street address City Postal code Country
Not applicable Addis Ababa PO Box 2490 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child weight-for-age z-score When child is 6.5 years of age
Secondary Outcome Cumulative child mortality 6.5 years after the child¿s birth date
Secondary Outcome Maternal mental health (using Self-Reporting Questionnaire, 20-item version) 6.5 years after the child¿s birth date
Secondary Outcome Child mental health (using Strengths and Difficulties Questionnaire) 6.5 years after the child¿s birth date
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Butajira Demographic Surveillance Site Meskan, Mareko and Silti districts Gurage Zone Southern Nations, Nationalities and People¿s (SNNP) region Not applicable Mareko Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute of Psychiatry, King¿s College London De Crespigny Park, Camberwell London De Crespigny Park, United Kingdom Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Atalay Alem Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University Addis Ababa PO 9086 Ethiopia
Professor Paul McCrone Health Service and Population Research Department, Institute of Psychiatry, De Crespigny Park, Camberwell London SE5 8AF United Kingdom
Professor Michael Dewey Health Service and Population Research Department, Institute of Psychiatry, De Crespigny Park, Camberwell London SE5 8AF United Kingdom
Professor Martin Prince De Crespigny Park, Camberwell London SE5 8AF United Kingdom
Dr Charlotte Hanlon Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University Addis Ababa PO 9086 Ethiopia
Girmay Medhin Aklilu-Lemma Institute of Pathobiology, College of Health Sciences, Addis Ababa University Addis Ababa PO1176 Ethiopia
Professor Bogale Worku Department of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Addis Ababa University Addis Ababa PO 9086 Ethiopia
Professor Damen Haile-Mariam School of Public Health, College of Health Sciences, Addis Ababa University Addis Ababa PO 9086 Ethiopia
Professor Atif Rahman University of Liverpool Liverpool L69 3BX United Kingdom
Dr Natasha Palmer London School of Hygiene and Tropical Medicine London WC1E 7HT United Kingdom
Dr Rob Whitley McGill University, Pine 1033 Montreal H4H 1R3 Canada
Dr Olayinka Omigbodun Department of Psychiatry, University College Hospital Ibadan PMB 5116 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Martin Prince martin.prince@kcl.ac.uk +44 207 848 0136 Institute of Psychiatry, De Crespigny Park, Camberwell
City Postal code Country Position/Affiliation
London SE5 8AF United Kingdom Professor of Epidemiological Psychiatry Co-Director, Centre for Global Mental Health
Role Name Email Phone Street address
Public Enquiries Charlotte Hanlon Charlotte.hanlon@kcl.ac.uk +251 912 803374 Department of Psychiatry School of Medicine
City Postal code Country Position/Affiliation
Addis Ababa PO 9086 Ethiopia Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Charlotte Hanlon Charlotte.hanlon@kcl.ac.uk +251 912 803374 Department of Psychiatry School of Medicine
City Postal code Country Position/Affiliation
Addis Ababa PO 9086 Ethiopia Associate Professor
REPORTING
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