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.: PACTR201704002216259 Date of Approval: 19/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title M-Health and Maternal Health care Services Use
Official scientific title Effects of Mobile-health on maternal health care services utilizations in Haramaya and Kombolcha Woreda, Oromia region, Eastern Ethiopia
Brief summary describing the background and objectives of the trial Background: Globally, rapid increase of mobile technology has generated new ways to address public health challenges and shift the paradigm of health care access and delivery. The primary aim of this study is to examine the effectiveness of Mobile health on maternal health care services utilization in Eastern Ethiopia. Methods/Design: Single-blind, randomized, controlled trial of 492 participants will be selected based on their districts and respective health centers as the unit of randomization. All pregnant mothers who fulfilled the inclusion and enrollment criteria will be randomized to mobile phone based intervention and standards of care or control with 1:1 allocation ratio. The intervention consists of series of 24 voice messages which will be sent every two weeks from the date of enrollment until close out time. The control group will receive existing standards of care without voice message. Data related to outcome variables will be assessed at Phase I, Phase II and Phase III data collection times. The primary outcome measures are the level of antenatal care visits and institutional delivery. Secondary outcome measures consist of the level of postnatal care visits and pregnancy outcome. Risk ratios will be used as the measure of the effect of an intervention on the outcomes, and this will be estimated with 95% Confidence interval. All analyses will be based on the intention to treat principle. Discussions: This study will generate evidence on the effectiveness of mobile phone based voices message for early initiation of maternal health care service use and its up-take in resource-limited setting. The finding of this trial will help policy makers and other stake holders to implement mobile health for better maternal health care service use.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Maternal Health,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial mobile phone based voices message
Anticipated trial start date 01/08/2017
Actual trial start date
Anticipated date of last follow up 02/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 454
Actual target sample size (number of participants) 454
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
Parallel: different groups receive different interventions at same time during study Randomised Simple Randomization using Coin-tossing or Lottery to allocate Study Unit as control and Intervention group and Using a randomization table created by computer to select study subjects . First, Haramaya District and Kombolcha District are selected by Purposive method,then the two district was selected by lottery method with their respective health facility as Intervention and control group. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group M-health through Voice message Every two weeks from date of enrollment 12months a mobile phone based Voice message that will be send for ANC-follow up, EDD and PNC-follow up reminding during pregnancy and postnatal period. From date of enrollment, all Pregnant women in intervention group will receive reminding Voice Message which will be send every two weeks by selected and trained health professionals from intervention site 227
Control Group Standard care (standard maternal care without M-health intervention) From date of enrollment the control group will be have at maternal care as National standard 12months The control will take maternal Health care services per national protocol without M-health intervention. 227 Active-Treatment of Control Group
Experimental Group Mobile phone based Voice message Every two weeks from date of enrollment Maximum of 12 months mobile based voice message which will consist of reminding and information about advantage of Maternal health care services use will be sent 246
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria All pregnant mothers with gestational age of less than 16 weeks, who own private mobile phone (Not shared with family members), and willing to participate will be included. Exclusion Criteria ¿ All Mothers with special ANC care service use who will be referred from other health institutions during this study period to study area will be excluded from study. ¿ Critically sick mothers will be excluded from this study. 18 Year(s) 50 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 08/05/2017 Institutional Health Research Ethics Review Committee (IHRERC)
Ethics Committee Address
Street address City Postal code Country
Bote Harar P.O .Box 235, Harar Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Level of having four or More Antenatal follow up At the end of study or after mother give birth.
Primary Outcome Level of institutional delivery After mother give birth
Primary Outcome Level of Postnatal follow up After mothers gave birth
Secondary Outcome Level of maternal Near-miss it will used case as references All cases(maternal Near-miss)will be registered at time points
Secondary Outcome Neonatal mortality From birth to 28 days of life
Primary Outcome Level of maternal Antenatal care use After the intervention will be completed
Primary Outcome Level of Institutional delivery The level of institutional delivery will be measured at the end of study
Secondary Outcome Level of Postnatal visit This outcome will also measured at the of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kombolcha Woreda Harar Harar 235 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Haramaya University Haramaya Harar 235 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Haramaya University Harar Harar 235 Ethiopia University
Primary Sponsor Haramaya University Haramaya Haramaya 138,Dire Dawa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Nega Assefa Kassa (MPH-RH, PhD) Harar Harar 235 Ethiopia
Afendi Abdi Mahamed Harar Harar 235 Ethiopia
Kedir Teji Roba Harar Harar 235 Ethiopia
Mitiku Teshome (MPH-Epidemiologist) Harar Harar 235 Ethiopia
Yadeta Dessie Harar Harar 235 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tilayie Feto gelanotilaye@gmail.com +251921843248 Harar
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Lecturer at Haramaya University
Role Name Email Phone Street address
Public Enquiries Yadeta Dessie yad_de2005@yahoo.com 251911741054 Harar
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Haramaya University /Chief Executive Director
Role Name Email Phone Street address
Scientific Enquiries Mitiku Teshome mitikkuuf@gmail.com +251-913036311 Harar
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Research & Publication Office Coordinator, College of Health & Medical Sciences
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information