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.: PACTR201907640298298 Date of Approval: 11/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF PHONE TEXT MESSAGES ON POSTNATAL CLINIC ATTENDANCE AMONG MOTHERS DELIVERING AT MULAGO - KAWEMPE HOSPITAL A RANDOMIZED CONTROLLED TRIAL
Official scientific title EFFECT OF PHONE TEXT MESSAGES ON POSTNATAL CLINIC ATTENDANCE AMONG MOTHERS DELIVERING AT MULAGO - KAWEMPE HOSPITAL A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial The highest risk of death for the mothers and new-borns is the postnatal period, yet it is given the least attention by both the mothers with their babies and the healthcare facilities as compared to pregnancy and child immunization. Many mothers do not return for postnatal clinic. Postnatal complications, apart from resulting into mortality, also impact negatively and heavily on the physical, mental and psychological aspects of the mothers and neonates more especially in Sub-Saharan Africa. This study seeks to assess the effect of phone text message reminders on postnatal clinic attendance at six weeks after delivery and acceptability among mothers who deliver at Mulago - Kawempe hospital. 1. To assess effect of phone text message reminders on postnatal clinic attendance at six weeks after delivery among women who had delivered at Mulago – Kawempe hospital. 2. To assess acceptability of phone text message reminders to women who had delivered at Mulago - Kawempe on postnatal clinic attendance at 6th week.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied postnatal care
Purpose of the trial phone text message reminders
Anticipated trial start date 28/01/2019
Actual trial start date 11/02/2019
Anticipated date of last follow up 04/03/2019
Actual Last follow-up date 29/05/2019
Anticipated target sample size (number of participants) 488
Actual target sample size (number of participants) 488
Recruitment status Completed
Publication URL African Journal of Medicine
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phone text message reminders Two phone text messages sent to postnatal mother 3 days and 1 day to scheduled return date (total of 4 messages). Messages send between 0800 - 1200 hours and 1600 - 2000 hours Two days Total of 4 messages sent to postnatal mothers in intervention group: two sent 3 days and two one day to postnatal review date at 6 weeks after delivery. At seven weeks, all those who did not return for postnatal review at 6 weeks were called to find out whether they attended postnatal clinic in other health centers and why they were unable to come back to Mulago - Kawempe for postnatal review. 244
Control Group Routine postnatal care No reminders 6 weeks Will undergo routine care 244 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Delivered in Mulago - Kawempe hospital Possess a personal mobile phone Stays within a 30 Km distance radius from the hospital Willing to participate in study, signed informed and written consent Stays further than 30 Km distance from Mulago - Kawempe hospital Unwilling to participate in study No personal mobile phone or unable to read text messages Adult: 19 Year-44 Year 16 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 08/02/2019 College of Health Sciences school of medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O Box 7072 Kampala, Uganda Kampala 0256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Return at 6 weeks for postnatal clinic at Mulago - Kawempe hospital At 6 weeks postnatal
Secondary Outcome amount of money a mother is willing to pay for the SMS At 6 weeks postnatal
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Referral hospital Mulago - Kawempe Kampala 0256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal savings Kampala Kampala 0256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Kiwanuka Pontian C/O Makerere University, college of health sciences, P.O Box 7072, Kampala, Uganda Kampala 0256 Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Dan K. Kaye P. O Box 7072, Kampala, Uganda Kampala 0256 Uganda
Dr. Susan Obore P. O Box 7072, Kampala, Uganda Kampala 0256 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pontian Kiwanuka pontiankiwanuka@yahoo.com +256782364875 Kampala
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Post graduate student in Obstetrics and Gynaecology of Makerere University
Role Name Email Phone Street address
Scientific Enquiries Daniel Kaye Kabonge dankkaye@yahoo.com +256772587952 Kampala
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Lecturer Makerere University department of Obsterics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Susan Obore arsuob@yahoo.co.uk +256772692432 Kampala
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Lecturer Makerere University department of Obsterics and Gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data to be shared include participant number, socio demographic characteristics, outcome and mode of delivery and postnatal attendance details Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available for sharing for 2 years from the completion of the study Access criteria will be controlled Analysis permitted will be by Intention To treat Process of requesting for data will be through email and the principal investigator will be responsible for granting access. Requests will be reviewed based on quality of requests
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.mak.ac.ug 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