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.: PACTR202402586118757 Date of Approval: 02/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Boosting Post-Natal Care with text messages: An Interventional Study
Official scientific title Impact of short messaging service (SMS) on post-natal clinic visit and services utilization: a randomized controlled trial
Brief summary describing the background and objectives of the trial The postnatal period is described as the initial six weeks following birth, which are essential to a mother's and her newborn's health and survival. In developing nations, a significant proportion of maternal and child deaths occur during this period. Postnatal care has been found to reduce neonatal and maternal morbidity and mortality by a substantial percentage; however, there is poor utilization of postnatal care services around the world, especially in developing countries. Hence, there is a need for adequate health education about postnatal care and its services. The objective of this study is to test the efficacy of short message service (SMS) interventions in improving postnatal clinic visits and utilization of postnatal care services.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 26/02/2024
Actual trial start date
Anticipated date of last follow up 27/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 204
Actual target sample size (number of participants)
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Short Messaging Service twice weekly 11 weeks +/- 2 weeks . The intervention group will receive text messages through their personal cell phone 2 times a week from the 35th week of gestation to 6 weeks after delivery. The text message content will be adapted from the mobile alliance for maternal action, a literature review, and postnatal care services guidelines by WHO. The messages will be reviewed by public health physicians, obstetricians, pediatricians, and other experts in the field of maternal and child health. The messages will be in English and Yoruba (the local language), and participants will be free to select their preferred language. Based on the gestational age, different messages are sent. When a participant in either of the groups delivers, she is to send an SMS to indicate she has delivered. This helps to change a large part of the messages received and a person-specific postnatal clinic visit reminder 2 days and a day before each visit. Similar messages, with minor changes, will be sent to the husband or the closest caregiver so as to encourage the women to attend the postnatal clinic and utilize the services. In situations where the woman does not send a message to indicate she has delivered after her expected date of delivery and efforts to contact her husband or closest care giver prove abortive, she will be said to have been lost to follow up. 102
Control Group Routine care 11 weeks +/- 2 weeks The control group will receive care as usual and will be encouraged to make postnatal clinic appointments. However, they will not receive text messages throughout the period of the study. 102 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age ≥ 18 years old and able to give informed consent • Pregnant women at gestational age of 28 – 34 weeks • Ability to read and communicate in English language or local language (Yoruba) • Possession of personal cell phone that patient has access to all times • Ability to receive, comprehend and reply to an SMS in English or Yoruba. • Pregnant women below gestational age of 28 weeks and above gestational age of 34 weeks • Biological impairment in reading or responding to SMS such as, but not limited to, loss of vision, visual field cuts, aphasia • Pregnant women who will not be available in Nigeria for follow up for at least 6 weeks after delivery Adult: 19 Year-44 Year 18 Year(s) 55 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 12/02/2024 University of Ibadan Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth Road Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postnatal clinic visits and utilization of its services among women who receive comprehensive text messages on the educational aspect of postnatal care and reminders for postnatal care visits from the 35th week of gestation to six weeks after delivery, alongside their husband or closest care giver, will be better compared to those who do not At the end of each participants follow up, which is 6 weeks after birth
Secondary Outcome The postpartum health-related quality of life (HRQOL) and postnatal services knowledge, will be better in the intervention group At the end of each participants follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health and Care Research 15 Church Street London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Royal Society of Tropical Medicine and Hygiene 21 John Street London United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Innocent Dike innoceejay@gmail.com +2349066094436 Alapo Street
City Postal code Country Position/Affiliation
Ido Ekiti Nigeria Federal Teaching Hospital Ido Ekiti
Role Name Email Phone Street address
Public Enquiries Oluwabunmi Adeyeye bvcadeyeye@gmail.com +2348064810347 ABH, Queen Elizabeth Street
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Abigail Oyedokun abigailoyedokun3@gmail.com +2348038638415 ABH, Queen Elizabeth Street.
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria University of Ibadan
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In adherence to our commitment to transparency and scientific collaboration, we intend to share de-identified individual participant data from this study. Access to the IPD will be provided upon request to qualified researchers, following the completion of a data sharing agreement. The purpose of sharing this data is to facilitate further research, validate findings, and contribute to the advancement of knowledge in the field. Requests for access to the IPD can be submitted to the principal investigator via e-mail (innoceejay@gmail.com) and will be reviewed by the Data Sharing Committee. The data shared will be stripped of any personally identifiable information to ensure participant confidentiality. Clinical Study Report,Informed Consent Form We aim to make the data available within 6 months of the study completion date and 1 month of the request approval. Related research proposal with ethical approval.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information