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.: PACTR202211547107725 Date of Approval: 22/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect Of Mobile Phone Messaging On Maternal And Child Health Service Uptake
Official scientific title Effect Of Mobile Phone Messaging On Maternal And Child Health Service Uptake In Southern Ethiopia: A Cluster Randomized Controlled
Brief summary describing the background and objectives of the trial Though there was little evidence highlighting the opportunities for mHealth interventions in the country, the lack of comprehensive information on postpartum care and child feeding practice thwarts decision making, especially in the Southern Ethiopia. Maternal and child mortalities are still higher in Southern region compared to others, despite all the efforts over the last few decades. Even so, mobile technology cannot entirely put these problems beyond us; it can convey significant transformation that can reduce maternal and child mortalities through improving access to timely information, compliance with appointments and treatments, awareness, unnecessary travels, decision making, child welfare, logistics, medical errors, women empowerment in decision making, and other benefits. Thus, the current study aimed to apply mHealth to improve postpartum family planning and timing of complementary feeding in Southern Ethiopia to show implementation strategies and further policy directions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2023
Actual trial start date 01/01/2023
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 632
Actual target sample size (number of participants) 632
Recruitment status Active, not 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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Message group one messages every two weeks plus one within 24hours of coming appointment 10 months In this arm, a mobile-phone-based text and voice message as a reminders and health education information about the advantage and positive outcomes of frequent and timely use of maternal health services (ANC, institutional delivery, full PNC, maternal nutrition, postpartum family planning, and EDD) and child feeding practices (prelacteal, exclusive breastfeeding, timely complementary feeding, and infection prevention), where detail benefits of childhood vaccination also included. We will send reminders of the appointment dates as a voice or text message depending on the literacy status of the mothers in addition to standards of care (SOC). We will use unique classical notification voice to help mothers for easily recognition of alerts. We will send one text/voice message every two weeks starting from the baseline enrollment and additional text/voice message within 24 hours to appointment date to the mother/spouse/shared phone number a mother registered. We will prepare the content of all the reminders in English and translated into Amharic and then to the local language of the women. We will script voice messages to a female voice through a smartphone recording). Text messages will be limited to 160 characters, while the voice will be limited to 1 minute audio (13,42). Finally, these messages will be loaded on the mobile phone in text/voice message form to be sent regularly every week at 7:00 a.m. to the intervention group. The investigators will prepare a way of messaging from personal computers with the help of messaging software that will be customized or locally developed for the messaging purpose. There will be a way of checking if the mother read/listened to the message in customized software and a multimedia messaging system is an optionally available method. If the mother did not see, read, or listened to the message, the investigators/trial manager make a phone call to ensure the mother is still in the follow-up and make necessary advice. 316
Control Group Standards existing care no change-standard care as usual. The care that has been given without involvement of any external or knowledge of any going on experiment. 10 months Participants in the control group will receive the SOC. The trial will not influence controls so that care giver will continue as usually. They may advise their clients or not as they usually do. The data collection tools will be the same for both trial arms (Trial arms A and B), except for mobile-phone-based text/voice message status-related questions for the intervention groups. If the study participant moves from the study area before the study is completed or withdraws from the study before the final data collection period, we register them as dropouts from the follow-up. 316 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Taking service in selected HF Declared GA of pregnancy Visited selected health facility for ANC Access to the mobile phone (self, spouse, or shared) Inability to provide mobile phone no way to access mobile phone-based messages Inability to take basic women’s service (need special service). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 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 15/11/2022 Arba Minch University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
N/A Arba Minch 21 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Two primary outcomes - the percentage of postpartum family planning and timing of complementary feeding 6 months after birth of child
Secondary Outcome Secondary outcome(s): Percentage of non-prelacteal feeding, percentage of exclusive breastfeeding, and the number of children who completed the one-year childhood vaccination 10 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Arba Minch Delfana primary hospital not applicable Arba Minch 21 Ethiopia
Secha Health center N/A Arba Minch 21 Ethiopia
Sawla health center N/A Gofa 55 Ethiopia
Zala Health center N/A Gofa 55 Ethiopia
Gath Helth Center N/A Gofa 55 Ethiopia
Berber Health Center N/A Arba Minch 21 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Arba Minch University Research coordinator office N/A Arba Minch 21 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Arba Minch University N/A Arba Minch 21 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
University of Maastricht Universiteitssingel 50, 6229 er Maastricht Maastricht 616 Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Girma Gilano girmagilano@gmail.com +251913930384 N/A
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Assistant professor of Public Health Informatics at Department of health informatics school of public health college of medicine and health sciences Arba Minch University Arba Minch
Role Name Email Phone Street address
Scientific Enquiries Andre Dekker andre.dekker@maastro.nl +310884455600 Minderbroedersberg 4-6 6211 LK Maastricht
City Postal code Country Position/Affiliation
Maastricht 616 Netherlands Manager Research and Education at MAASTRO Clinic Maastricht The Netherlands
Role Name Email Phone Street address
Public Enquiries Riane Fijten rianne.fijten@maastro.nl +31643566956 Paul-Henri Spaaklaan 1, 6229 EN Maastricht, the Netherlands
City Postal code Country Position/Affiliation
Maastricht 616 Netherlands Assistant Professor of Clinical Data Science at Maastricht University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data that will be collected in this trial will be anonymized and available for sharing with scientific community Clinical Study Report,Informed Consent Form,Study Protocol the data from this trial will be shared within the first six month of the completion of the study. The anonymized data will be openly available
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