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.: PACTR202205597300585 Date of Approval: 04/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of mHealth intervention in improving maternal health care services utilization and birth outcomes
Official scientific title The effect of mHealth intervention in improving maternal health care services utilization and birth outcomes: a prospective non-randomized control trial
Brief summary describing the background and objectives of the trial Globally, mobile phone technologies, including short message service (SMS), have become emerging as an essential tool for supporting the healthcare system and achieving the desired outcomes. However, evidence on their effectiveness in improving maternal health care utilization is limited. We also found an absence of interventional studies aimed at creating such a platform, suggesting much more is to be learned and more is to be done regarding the potential impact of mHealth interventions in improving maternal and child health care services utilization in Ethiopian context. The study, therefore, aims to examine whether mobile phone-based SMS with calls initiative for women increases their uptake of focused antenatal care (FANC) and skilled birth attendant (SBA), as well as decreases low birth weight (LBW) in neonates.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Not applicable
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 20/07/2019
Actual trial start date 15/10/2021
Anticipated date of last follow up 10/05/2022
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 468
Actual target sample size (number of participants) 386
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention Group The frequency will be one message per week, with calling fortnightly. for six months The intervention consists of a manual SMS system provided to mothers with bidirectional text messaging and calling. While only women with registered phone numbers received text messages, all women in the intervention group will be given both text messaging and calling for counselling to contact their health care provider(s). The SMS component and phone calls will be providing detailed health and nutrition education, counseling on regular moderate exercise, danger signs, programmed appointment reminders, encouraging attendance at routine ANC, relevance of skilled delivery attendance. The frequency will be one message per week, with calling fortnightly. The content of the messages will be developed by a team of experts, including Pediatricians, Gynecologist, and local partners 194
Control Group Control group Usual care for six months Control group women will receive routine ANC and were followed up as per hospital protocol 192 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible for inclusion in the study, a pregnant woman attending either of the selected hospital must reside in the zone, must own a mobile phone or access to a phone number of a husband/ friend/mother who could relay the messages, and must be able to read and write either English or Amharic language. Pregnant women with critical health conditions who register at the hospital or who have temporal residents of the zone or spent significant time outside their residence Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 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
Yes 09/05/2019 Institutional research ethics review committee Debre Markos University College of Health Sciences
Ethics Committee Address
Street address City Postal code Country
Debre Markos Debre Markos 6000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary endpoint measure will be the number of women receiving four or more ANC visits. by the end of follow-up time
Secondary Outcome Secondary outcomes will be measured skill birth attendant and low birth weight. by the end of follow-up time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Markos Hospital Debre Markos Debre Markos 6000 Ethiopia
Finoteselam Hospital Finoteselam Finoteselam 6000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Debre Markos University Debre Markos Debre Markos 269 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Debre Markos Debre Markos Debre Markos Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr. Amanuel Abajobir Kenya Addis Ababa Kenya
Setegn Eshetie Kingly street Adelaide 2600 Australia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fasil Wagnew fasilw.n@gmail.com +61449535495 Belconnen
City Postal code Country Position/Affiliation
Page Australia Debre Markos University
Role Name Email Phone Street address
Scientific Enquiries Getiye Dejenu dgetiye@gmail.com +61426692679 Oxford
City Postal code Country Position/Affiliation
Sydney Australia Debre Markos
Role Name Email Phone Street address
Public Enquiries Aster Tadesse astutadesse84@gmail.com +25193582317 Debre Markos
City Postal code Country Position/Affiliation
Debre Markos Ethiopia Debre Markos University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After data collection is completed, we will share the summary results of individual participant data. Informed Consent Form,Statistical Analysis Plan,Study Protocol It will be available in an anonymous manner upon request from June 17, 2022. will be accessible to any researchers or reviewers who might review the data and perhaps perform some new data analysis, the decision will be in the hands of the Principal investigator and colleagues in University hospitals involved, plus health and ethical authorities following legislation based on WHO criteria
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