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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202106720144533 Date of Registration: 21/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title KENYA PRONTO TRAINING TRIAL
Official scientific title IMPACT OF PRONTO TRAINING IN EMERGENCY OBSTETRIC AND NEWBORN CARE ON 24 HOUR NEONATAL MORTALITY
Brief summary describing the background and objectives of the trial One third of neonatal deaths in Kenya are due to birth asphyxia resulting from intra-partum complications . This can largely be prevented by enhancing the capacity of health facilities to provide quality routine and emergency obstetric and neonatal care (EmONC). Research has demonstrated that simulation based training is an effective method for improving provider knowledge, skill, and behavior. PRONTO is an Emergency Obstetric and Newborn (EmONC) training model aiming to improve skills, communication and teamwork through highly realistic, in-situ simulation. In this study, we sought to evaluate the impact of PRONTO training on 24 hour neonatal mortality in health facilities in Kisii County in rural Western Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/07/2014
Actual trial start date 01/07/2014
Anticipated date of last follow up 31/07/2016
Actual Last follow-up date 31/07/2016
Anticipated target sample size (number of participants) 9646
Actual target sample size (number of participants) 13326
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PRONTO Simulation Training for Health Care Providers three months simulation and team based training in emergency obstetric and neonatal care 8
Control Group None standard of care three months Standard of care (control) 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
health facilities offering obstetric services level 1 facilities, non government facilities and those with less than 10 deliveries per month New born: 0 Day-1 Month 0 Day(s) 1 Day(s) Both
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 24/04/2014 KNH UON Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Off Hospital Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 24 hour neonatal mortality 24 hours after delivery
Secondary Outcome Neonatal morbidity 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
16 hospitals in Kisii County Kisii County Kisii Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
United States Agency for International Development 500 Fifth Street, NW Washington DC 20001 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor United States Agency for International Development PO Box 629 Village Market 00621 Nairobi Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dilys Walker 550 16th. Street San Francisco CA 94158 San Francisco 94158 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Onesmus Gachuno owgachuno@yahoo.com +254722851914 Off Ngong Road
City Postal code Country Position/Affiliation
Nairobi Kenya Senior Lecturer University of Nairobi
Role Name Email Phone Street address
Scientific Enquiries Minnie Kibore minniewk@gmail.com +254722493974 Off Ngong Road
City Postal code Country Position/Affiliation
Nairobi Kenya Child Health Manager Children Investment Fund Foundation
Role Name Email Phone Street address
Public Enquiries Onesmus Gachuno owgachuno@yahoo.com +254722851914 Off Ngong Road
City Postal code Country Position/Affiliation
Nairobi Kenya Senior Lecturer University of Nairobi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study protocol, analysis plan, consent forms, study report and De-identified data will be available upon request Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within two weeks of request Only approved users will be allowed access to the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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