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.: PACTR201212000457326 Date of Approval: 13/11/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Community Based Maternal and Neonatal Health and Nutrition:Kenya
Official scientific title Community Based Maternal and Neonatal Health and Nutrition:Kenya
Brief summary describing the background and objectives of the trial The project will occur in 2 phases and will include an external evaluation as well as other research monitoring. Community health workers in intervention sites in Western Province, Kenya will be trained to promote facility based pregnancy and birth care and CHWs and TBAs will be trained to accompany and support women in labor. HEalth workers at level 2 and 3 facilities will be given simulation training in EmOC. The trial aims to show improvement in maternal and neonatal health and survival.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CBMNH Kenya
Disease(s) or condition(s) being studied maternal and neonatal survival and health,Neonatal Diseases,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 21/11/2012
Actual trial start date 30/11/2012
Anticipated date of last follow up 30/11/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60000
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
Non-randomised Open-label(Masking Not Used)
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Trained CHWs/Health Facility Workers 3 years Training of CHWs and Facility Health Workers in intervention districts 60000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Residence in one of the intervention districts Resident of one of the comparison districts 18 Year(s) 45 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 05/07/2012 University of Nairobi College of Health Sciences
Ethics Committee Address
Street address City Postal code Country
PO Box 19676-00202 Nairobi Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome More Pregnant women at risk and in need of emergency obstetric care will be identified, referred and managed at appropriate health facility to reduce morbidity and mortality due to pregnancy related causes At 1st ANC visit At 4th ANC visit Following Birth At first PNC check up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KENAFYA Building Behind Kakamega General Hospital Kakamega Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Micronutrient Initiative 180 Elgin Street Suite 1000 Ottawa k2p 2k3 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Micronutrient Initiative 180 Elgin Street Suite 1000 Ottawa k2p 2k3 Canada Funding Agency
COLLABORATORS
Name Street address City Postal code Country
University of Washington PRONTO Harborview Medical Center 325 9th ave Box 359931 Seattle 98104 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Test Test test@gmail.com 373923937376 Test
City Postal code Country Position/Affiliation
Test 7505 Kenya
Role Name Email Phone Street address
Principal Investigator Wambui Kogi-Makau wkogi@uonbi.ac.ke +245720933552 University of Nairobi ¿ Applied Nutrition Program P.O. Box 30197-0000
City Postal code Country Position/Affiliation
Nairobi Kenya Professor
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 Program Officer Maternal and Neonatal Health and Nutrition (MI)
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 Maternal and Neonatal Health and Nutrition (MI)
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