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.: PACTR201811548430910 Date of Approval: 30/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mobile phone use to increase postnatal clinic attendance
Official scientific title Efficacy of mobile phone use on patient retention in care in postnatal clinic in Nakuru
Brief summary describing the background and objectives of the trial Postnatal Clinic attendance has been shown to be an important strategy to improve neonatal survival by increasing mother’s knowledge on care of her baby and prompt recognition of illness and appropriate health seeking behaviour. Retention in the postnatal clinic has remained low especially in developing countries. In addition high client volumes and staff shortages impinge on the quality of services such that mothers are not adequately appraised on optimal infant feeding and recognition of neonatal danger signs. Use of mobile phones has largely been tested in improving uptake of other reproductive and child health services. This study aimed to assess the use of mobile phones as an intervention to increase postnatal clinic retention, promote exclusive breastfeeding and increase mother’s knowledge on neonatal danger signs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2017
Actual trial start date 01/11/2017
Anticipated date of last follow up 27/12/2017
Actual Last follow-up date 28/02/2018
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 180
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Current standard of care arm none 6 weeks participants received the standard of postnatal care.Before discharge,they received postnatal education.They were verbally reminded to attend clinic. 59 Active-Treatment of Control Group
Experimental Group Text group weekly text reminders 6 weeks Mothers received weekly texts to remind them of 48 hour 2 weeks and 6 weeks visit.They aslo received educative messages on postnatal care. 60
Experimental Group Phone call group weekly phone calls 6 weeks mothers received weekly phone calls to remind them of 48 hour,2 weeks and 6 weeks visit. They were also reminded on topics covered in postnatal education on postnatal care. 61
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers who have access to mobile phones 2. Mothers willing to be followed up at NCRH 3. Mothers who deliver at term.(37 completed weeks) 4. Mothers discharged within 24 hours of delivery Mothers who do not have access to a mobile phone 2. Mothers who declined to participate in the study 3. Mothers who give birth to preterm babies. 4. Mothers with prolonged hospitalization. (More than 24 hours after delivery) New born: 0 Day-1 Month 0 Day(s) 1 Day(s) Both
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 21/09/2017 KNH UON ERC
Ethics Committee Address
Street address City Postal code Country
Hospital Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measured was retention in care at 48 hours, 2 weeks and 6 weeks. At discharge, each participant (mother-infant pair) was given a return date at day 2, 2 weeks and at 6 weeks 48 hour 2 weeks and 6 weeks
Secondary Outcome Exclusive breastfeeding rate were measured as self-reported duration of Exclusive breast feeding.  A mean score of the number of WHO neonatal danger signs listed by the study participants was done in each group The outcome of the infants was assessed at 6 weeks. 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nakuru County Referral Hospital Milimani Nakuru 20100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Zanzibar Road Nairobi 00504 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Munira Alkizim Zanzibar road Nairobi 00504 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Dalton Wmalwa Hospital Road Nairobi 00202 Kenya
Professor Ruth Nduati Hospital Road Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Munira Alkizim munirakhalid25@gmail.com 00254721336085 Zanzibar Road
City Postal code Country Position/Affiliation
Nairobi 00504 Kenya University Of Nairobi
Role Name Email Phone Street address
Public Enquiries Munira Alkizim munirakhalid25@gmail.com 00254721336085 Zanzibar Road
City Postal code Country Position/Affiliation
Nairobi 00504 Kenya University of Nairobi
Role Name Email Phone Street address
Scientific Enquiries Munira Alkizim munirakhalid25@gmail.com 00254721336085 Zanzibar Road
City Postal code Country Position/Affiliation
Nairobi 00504 Kenya University of Nairobi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The adherence to postnatal clinic was significantly higher for phone and text arms at 48 hour and 6 weeks (p value <0.05) At 2 weeks only phone call arm had significantly higher postnatal clinic attendance RR=1.24 (95% CI 1.0, 1.5 p =0.05). There was a 25% increase in text arm and 29% in phone call arm in neonatal danger signs identified, p= <0.0001 for both text and phone versus control. Exclusive breastfeeding rates and outcomes in intervention arms was higher but not statistically significant. 10/11/2018 10/11/2018
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks not applicable
Changes to trial information