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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.: PACTR201212000457326 Date registered: 2012/11/13
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
Purpose of the trial Education/Counselling/Training
Anticipated trial start date 2012-11-21
Actual trial start date 2012-11-30
Anticipated date of last follow up 2015-11-30
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 60,000   
Recruitment status Not yet recruiting
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
Single group: all participants receive same intervention throughout study 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 Min age Max age Gender
Residence in one of the intervention districts Resident of one of the comparison districts 18 Years 45 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 2012/07/05 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 Fax
Principal Investigator Dr Test Test test@gmail.com 373923937376
Street address City Postal code Country Position / Affiliation
Test Test 7505 Kenya
Role Name Email Phone Fax
Principal Investigator Dr Wambui Kogi-Makau wkogi@uonbi.ac.ke +245720933552
Street address City Postal code Country Position / Affiliation
University of Nairobi ¿ Applied Nutrition Program P.O. Box 30197-0000 Nairobi Kenya Professor
Role Name Email Phone Fax
Public Enquiries Ms Emily Gold egold@micronutrient.org 6137826802
Street address City Postal code Country Position / Affiliation
180 Elgin Street Suite 1000 Ottawa k2p2k3 Canada Program Officer Maternal and Neonatal Health and Nutrition (MI)
Role Name Email Phone Fax
Scientific Enquiries Ms Emily Gold egold@micronutrient.org 6137826802
Street address City Postal code Country Position / Affiliation
180 Elgin Street Suite 1000 Ottawa k2p2k3 Canada Program Officer Maternal and Neonatal Health and Nutrition (MI)