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.: PACTR202405867304686 Date of Registration: 02/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Developing and Testing the Effectiveness of a Contexualized Client-Provider Integrated mHealth System in Monitoring incidences and Improving Knowleadge on Obstetric Violence in Tanzania
Official scientific title Contexualized Client-Provider Integrated mHealth System for monitoring obstetric violence in Tanzania
Brief summary describing the background and objectives of the trial Background: Violence during pregnancy, labour and delivery is a critical issue globally. However, there remains a lack of consensus on operational definitions of the components and best evidence-based practices to asses and monitor since the definitions of respect, disrespect, and abuse can differ among cultures, traditions,and places . Aim :This study aims at developing context specific component of obstetric violence and developing and testing the effectiveness of client-provider mHealth integrated system in monitoring incidences and improving knowledge on obstetric violence in central zone, Tanzania Conclusion: Developing context-specific components of obstetric violence and mHealth intervention may be useful step to inform policy makers for evidence based strategies and interventions to reduce obstetric violence and promote respectful maternity care.
Type of trial Non-Randomised
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 Obstetric violence or mistreatment of women during pregnancy,childbirth and after childbirth
Purpose of the trial Prevention
Anticipated trial start date 15/04/2024
Actual trial start date 15/05/2024
Anticipated date of last follow up 15/06/2025
Actual Last follow-up date 30/06/2025
Anticipated target sample size (number of participants) 540
Actual target sample size (number of participants) 540
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Non-randomised 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 Mobile health intervention Pregnant women and health care providers will be interacting with the mHealth system 5 days per week and they will be receiving health education messages about obstetric violence twice per week 6 months Pregnant women enrolled in the mHealth system will interact with the system and report all bad events done to them while receiving care at the Health facilities,At the same time Health care providers enrolled in the system will also be able to make self reflection of their practice by responding to questions from the system 180
Control Group Routine care Once per month ,depending on the pregnant mother's condition 6months A total of 360 pregnant women will be enrolled and saved as a control group ,They will receive routine care being provided in local Antenatal clinics and routine care and treatment provided in delivery rooms 360 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women at 12-14 weeks gestation age ,who will agree to participate will be enrolled to the study and who are mentally fit Preganant women who are above 14 weeks of gestation Adult: 18 Year(s)-44 Year(s) 18 Year(s) 45 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 28/06/2023 MUHAS Research and Ethics committee
Ethics Committee Address
Street address City Postal code Country
Dar es salaam Dar es salaam 65001 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of obstetric violence in Central zone ,Tanzania End of the intervention
Secondary Outcome Knowledge on obstetric violence before and after the intervention to both contro and intervention group
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makole Health cenre Makole Dodoma 1249 United Republic of Tanzania
Sokoine Health centre Sokoine Singida 76 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The University of Dodoma Makulu Dodoma 259 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The University of Dodoma Makulu Dodoma 259 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 Makulu
City Postal code Country Position/Affiliation
Dodoma 395 United Republic of Tanzania Corrsponding author
Role Name Email Phone Street address
Scientific Enquiries Lilian Mselle nakutz@yahoo.com +255717565610 Upanga
City Postal code Country Position/Affiliation
Dar es salaam 65001 United Republic of Tanzania Supervisor
Role Name Email Phone Street address
Scientific Enquiries Stephen Kibusi skibusi@gmail.com +255712600966 Makulu
City Postal code Country Position/Affiliation
Dodoma 395 United Republic of Tanzania Supervisor
Role Name Email Phone Street address
Scientific Enquiries Nathanael Sirili drnsirili@gmail.com +25513730179 Upanga
City Postal code Country Position/Affiliation
Dar es salaam 65001 United Republic of Tanzania Supervisor
Role Name Email Phone Street address
Public Enquiries Theresia Masoi jtheresia2008@yahoo.com +255765077822 Makulu
City Postal code Country Position/Affiliation
Dodoma 395 United Republic of Tanzania Principle investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As a team, we are committed in promoting transparency and advancing scientific knowledge through sharing of individual participant data (IPD) collected during our research. Access to the IPD will be provided upon request to qualified researchers for research purposes, subject to ethical approvals and data use agreements. To request access to the IPD, please contact Muhimbili University of Health and Allied Sciences through the Research and Ethical committee to be reviewed. Our research team to ensure compliance with ethical standards and data sharing policies will also review requests. The IPD will be shared in its original form, accompanied by documentation and descriptive information (metadata) to aid in its comprehension and utilization. Access to the data will be granted within the timelines specified by relevant ethical approval authorities. We kindly request that users of the IPD acknowledge its origin in their publications and presentations by referencing the original study and recognizing the researchers involved in data collection and sharing. For inquiries related to IPD sharing, please contact Theresia Masoi at +255765077822 Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1year Data will be available under request to Muhimbili University of Health and allied sciences to qualified researchers for research purposes, subject to ethical approvals and data use agreements
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet published 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