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.: PACTR201801002231314 Date of Approval: 23/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Utilization of Short Message Service to Enhance Uptake of Fucused Ante-Natal Care Among Women in Tharaka Nithi County, Kenya
Official scientific title Utilization of Short Message Service to Enhance Uptake of Fucused Ante-Natal Care Among Women in Tharaka Nithi County, Kenya
Brief summary describing the background and objectives of the trial In Kenya, the maternal mortality ratio is high at 362 maternal deaths per 100,000 live births. Focused ante natal care approach recommends four targeted visits. In Tharaka Nithi County, the level of uptake of focused ante natal care is 56%. Socio-economic, pregnancy related and institutional factors are known to have influence on uptake of focused ante natal care but their effect after using mobile phone short message service as a reminder has not been established. The main objective of this study is to assess the influence of mobile phone short message service on uptake of focused ante natal care among pregnant women in Tharaka Nithi County. A single blind randomized controlled trial will be carried in Chiakariga ward within Tharaka Nithi County. The sample size was calculated to show an effect size of 15%, at 5% level of significance and at a power of 90%. Assuming a dropout rate of 10%, each group will have 233 participants. Eligible pregnant women will be recruited after which systematic sampling will be used to identify the study participants. A database will then be created for all selected subjects. The subjects will be randomly allocated through a computer application to interventional or control arm. The interventional group will be sent three short message services while the control group will not. The short message services will have content reminding the women of their next ante natal clinic appointment. Semi structured questionnaires and key informant interview guide will be used in data collection. Descriptive statistics will be used to summarize categorical data to percentages and proportions while continuous data will be summarized into measures of central tendency. Chi square and multiple logistic regression will be used to test the association between dependent and independent variables. The study will generate information that may enable county and national governments to integrate short message service reminders in service provision to enhance
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Focused Ante natal care,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/12/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 30/06/2017
Anticipated target sample size (number of participants) 244
Actual target sample size (number of participants) 222
Recruitment status Closed to recruitment,follow-up continuing
Publication URL not applicable
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Computer software randomization at a Ratio of 1:1 Central randomization - Single blind Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Short message service 1 4 Months SMS reminder to attend ante natal clinic 20
Control Group Reminder in ante natal book 1 4 Months Date reminder in a book to attend ante natal clinic 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women attending rural health centers First visit to ante natal clinic Willing to give informed consent Possession of mobile phone Critically ill patients attending ante natal clinic Unable to read SMS and has no relative or friend who can assist 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 06/10/2016 Kenyatta University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Thika Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Enhance uptake of focused ante natal care After delivery
Secondary Outcome Skilled birth attendance at birth After delivery
Secondary Outcome Post natal care at 2 weeks Two weeks after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chiakariga Health centre Off Mate Road Chuka 60400 Kenya
St. Orsola Matiri Hospital Off Mate Road Chuka 60400 Kenya
Tunyai health centre Along Mate Road Chuka 60400 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Thika Road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta University Thika Road Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Tharaka Nithi County Along Mate Road Chuka 60400 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eliphas Gitonga gitonga.eliphas@ku.ac.ke 0721406609 Thika Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Kenyatta University
Role Name Email Phone Street address
Public Enquiries Eliphas Gitonga gitonga.eliphas@ku.ac.ke 0721406609 Thika Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Kenyatta University
Role Name Email Phone Street address
Scientific Enquiries Jackim Nyamari gitonga.eliphas@ku.ac.ke +254721406609 Thika Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Kenyatta University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information