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.: PACTR201403000553372 Date of Approval: 16/05/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Community Based Maternal and Neonatal Health in Afar, Ethiopia
Official scientific title Community Based Maternal and Neonatal Health in Afar, Ethiopia
Brief summary describing the background and objectives of the trial The trial will be measuring the effectiveness of an intervention to train frontline health workers (including health extension workers and traditional birth attendants) in safe birthing practices including assisting in normal births and early identification and referral of complications, promotion and provision of ANC and promotion of key maternal and neonatal nutrition interventions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Maternal mortality and morbidity, neonatal mortality, maternal anemia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 16/07/2013
Actual trial start date
Anticipated date of last follow up 30/09/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 1940
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MaNHEP Training N/A 18 months Training of trainers and training 1940 Active-Treatment of Control Group
Control Group no- MaNHEP training 18 months no intervention 1940 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women of reproductive age who had given birth (including still births) in the 12 months prior to the survey, front line health workers (Health Extension Workers, Village Health Workers and Traditional Birth Attendants ), and community/household stakeholders. Women who have not given birth in the last 12 months. Men 18 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
No 21/05/2013 Ethiopian Health and Nutrition Research Institute (EHNRI) Gulelle Arbegnoch Street (the former Pasteur Institute) Ethiopian Health and Nutrition Research Institute (EHNRI)
Ethics Committee Address
Street address City Postal code Country
Gulelle Arbegnoch Street (the former Pasteur Institute) Gulele Sub City Addis Ababa Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ensure baseline information of intervention site 8 weeks of data collection + 8 weeks of analysis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MI Ethiopid N/A Addis Ababa 9086 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Micronutrient Initiative 180 Elgin Street SUite 1000 Ottawa k2p2k3 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Micronutrient Initiative 180 Elgin Street Suite 1000 Ottawa k2p2k3 Canada Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Emory University Bole Subcity, Kebele 03/05, House number 2347. Po. Box 793 Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mesganaw Fantahun Mesganaw.f@gmail.com +251911240194 Subcity Bole, Kebele 17/19/20 H.No. New P.O.Box 24762 Code 1000
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Professor/ University of Addis Ababa
Role Name Email Phone Street address
Public Enquiries Emily Gold egold@micronutrient.org 6137826802 180 Elgin Street Suite 1000
City Postal code Country Position/Affiliation
Ottawa k2p2k3 Canada Micronutrient Initiative
Role Name Email Phone Street address
Scientific Enquiries Emily Gold egold@micronutrient.org 6137826802 180 Elgin Street Suite 1000
City Postal code Country Position/Affiliation
Ottawa k2p2k3 Canada Program Officer/ Micronutrient Initiative
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information