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.: PACTR202008834066796 Date of Approval: 31/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Antenatal care service Utilization using a mobile health technology
Official scientific title The effectiveness of interactive mobile health technologies in improving antenatal care service utilization in Dodoma region, Tanzania: A quasi experimental study
Brief summary describing the background and objectives of the trial Background: Antenatal care provides a platform for important health care functions during pregnancy, including health promotion, screening, and diagnosis and disease prevention. Timely and appropriate utilization of antenatal care can prevent complications and ensure better maternal and newborn health care. The aim of this study was to assess the effectiveness of interactive mobile health technologies in improving antenatal care service utilization in Dodoma region, Tanzania
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IMHT
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 10/11/2017
Actual trial start date 04/01/2018
Anticipated date of last follow up 10/10/2018
Actual Last follow-up date 15/02/2019
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 450
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Interactive computerized messaging system A minimum of 3 health education messages were sent per week to pregnant women who were enrolled into the system 9 months Interactive mobile health system is a computerized system that ensures the provision of reproductive health and communication between pregnant woman and the medical practitioners. The system started working in January, 2018 whereby pregnant women who started their first antenatal visit below 20 weeks were recruited and enrolled at Makole Health Centre and Chamwino Dispensary. The participants were followed until delivery. The system tracks every visit diagnosis and assembles them to give the general health overview of a woman in each trimester of the visit. The system also included an SMS Module where pregnant mothers were notified with SMS texts about when to come for the next visit and were also given health tips and were also able to call and text back for clarification when need arises 150
Control Group Focused Antenatal care service utilization A minimum of one visit was offered per month as a routine service offered in the local clinic in Tanzania 9 months Control group continued with the routine ANC health education being offered in the local clinics as per Tanzania guideline 300 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women who started their first antenatal visit below 20 weeks and who agreed to participate Pregnant women who received health education messages from other sources through their phones Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 14 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 01/05/2018 University of Dodoma ethical committee
Ethics Committee Address
Street address City Postal code Country
259 DODOMA 0259 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To improve Antenatal care service utilization hence improve pregnancy outcome after the woman has delivered
Secondary Outcome Improve knowledge on key danger signs during pregnancy,labor,delivery and danger sings in newborn Before the intervention was administered and after the intervetion was administered ,after the woman wis delivered
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makole health center Chamwino dispensary and Dodoma Regional Hospital 395 DODOMA 0395 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
UNIVERSITY OF DODOMA 259 DODOMA 0259 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNIVERSITY OF DODOMA 259 DODOMA 0259 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator THERESIA MASOI jtheresia2008@yahoo.com +255765077822 395
City Postal code Country Position/Affiliation
Dodoma 0395 United Republic of Tanzania ASSISTANT LECTURER
Role Name Email Phone Street address
Public Enquiries ALEX ERNEST ibolinga@gmail.com +255767625828 259
City Postal code Country Position/Affiliation
Dodoma 0259 United Republic of Tanzania LECTURER
Role Name Email Phone Street address
Scientific Enquiries STEPHEN KIBUSI skibusi@gmail.com +255712600966 395
City Postal code Country Position/Affiliation
Dodoma 0395 United Republic of Tanzania LECTURER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No individual participants data will be shared Statistical Analysis Plan Not applicable Not applicalble
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 27/08/2020 10/12/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/08/2020 Result - 27/08/2020 Result - 27/08/2020 Result - 27/08/2020 Result - 27/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information