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.: PACTR201703002093382 Date of Approval: 11/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of mHealth as an appointment reminders on postnatal care uptake
Official scientific title Effect of Enhanced Reminders on Postnatal Clinic Attendance in Addis Ababa: A Cluster Randomized Control Trial.
Brief summary describing the background and objectives of the trial Missed appointment and failure to attend service is the main problem associated with low service utilization in low and middle-income countries which has serious clinical.Using technologies to remind appointment is considered as one of the future tools to increase maternal care service utilizations in low and middle-income countries like Ethiopia.The aim of this study is to assess the effect of enhanced reminders on postnatal visit uptake.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ANC DHS FTA PNC
Disease(s) or condition(s) being studied Maternal and Newborn Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/06/2017
Actual trial start date
Anticipated date of last follow up 12/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants)
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 randomisation using by using procedures such as coin-tossing or dice-rolling NA Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group appointment reminders SMS or Voice call at 3rd, 7th and 42th days after delivery and 48 hours before each visits 3 times for 6 weeks 1. Based on the national guideline of postnatal care in Ethiopia the timing for postnatal care in Ethiopia is on the 3rd day, 7th day and between 8-42 days so the intervention includes all PNC visit timings. The women will receive sequential reminders 48 hours before the next appointment. 175
Control Group appointment reminders standard care appointment reminder through Nurses and midwives working postpartum clinic 6 weeks The individuals in the control group will receive the standard care. The Standard care includes appointment on the 3rd ,7th and 42 days by which patients get a reminder to return for follow up (verbal reminder by the nurses at discharge) will be used. 175 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All mothers who give birth in the public health centers during the study period. Mothers with serious complications and need admission Mothers who do not consent to participate in this study 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
No 25/01/2017 UI/UCH, Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Institute for Advanced Medical Research and Training University College Hospital Ibadan Oyo State PMB 5017 GPO Ibadan Nigeria Ibadan 3026 Ethiopia
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 UI/UCH EC
Ethics Committee Address
Street address City Postal code Country
University of Ibadan Ibadan 3026 Nigeria
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 02/10/2017 Ethiopian Public Health Insitute(IRB)
Ethics Committee Address
Street address City Postal code Country
St. Paul st. Addis Ababa 1242/5654 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome number of postnatal visit 3rd day of postpartum period 7th day of postpartum period 42th day of postpartum period
Secondary Outcome Acceptability of reminders end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Ababa Health bureau Mickey Leland st Addis Ababa 30738 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Pan Africa University Life and Earth Sciences Institute (Including Health and Agriculture) University of Ibadan Ibadan 22133 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pan Africa University Life and Earth Sciences Institute (Including Health and Agriculture) University of Ibadan Ibadan 22133 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Africa Union Roosvelt Street (Old Airport Area) | W21K19 | Addis Ababa Addis Ababa 3243 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abraham Sahilemichael Kebede abrishya@yahoo.com +251910416780 Semen Mazegajia, near polland embassy
City Postal code Country Position/Affiliation
Addis Ababa 00251 Ethiopia student/University of Ibadan
Role Name Email Phone Street address
Public Enquiries Arowojolu Ayodele O. ayo_arowojolu@yahoo.com +2348033979478 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 00234 Nigeria Professor of Obstetrics and gynecology ,University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Ajayi IkeOluwapo. O. ikeajayi2003@yahoo.com +2348023268431 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 00234 Nigeria Reader/associate professor school of public health, University of Ibadan
REPORTING
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