Pan African Clinical Trials Registry
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205826916525 Date of Registration: 04/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Examining the Effectiveness of Mobile Telephone Communication Interventions on the Utilization of Antenatal Care Services Among Expectant Mothers in the Districts of Rakai and Kyotera in Uganda: Study Protocol for a Randomized Controlled Trial.
Official scientific title Mobile Telephone Communication and Utilization of Antenatal Care Services During Pregnancy. A Case Study of Kyotera and Rakai Districts- Uganda: Cluster Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Uganda as a country still grapples with a high maternal mortality rates of 336 deaths per 100,000. Despite the criticality of antenatal care attendance in saving lives of expectant mother, reports indicate that mothers don’t have adequate information regarding available antenatal care services. Antenatal care attendance stagnates at 30% in the districts of Rakai and Kyotera below the desired national utilization of 47.5%. This article describes a protocol for investigating the effectiveness of mobile telephone communication interventions on the utilization of antenatal care services among expectant mothers in the districts of Rakai and Kyotera in Uganda. Overall, 28 health facilities will be randomly sample and allocated into the intervention and control arms at a ratio of 1:1. A total of 2214 expectant mothers receiving antenatal care from the 28 health facilities will be enrolled through systematic sampling. Mothers in the intervention arm will receive mobile telephone voice and text messages reminders for scheduled ANC visits while expectant mothers in the control group will not get any reminders for scheduled ANC visit and maternal health information through the mobile telephone communication platform. Expectant mothers in both groups will provide baseline data, midterm data will be obtained from the ANC registers at 6 moths while end of term data will be collected after an intervention period of 12months. The study will focus on achieving the following objectives among others a) To examine effects of mobile telephone communication on the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts, Uganda. b) To assess expectant mother factors influencing mobile telephone communication among pregnant women in Kyotera and Rakai Districts, Uganda. c) To evaluate effects of patient factors in the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts, Uganda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MTCANC
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Antenatal Care Utilization with exposure to mobile telephone communication reminders.
Purpose of the trial Education /Training
Anticipated trial start date 03/01/2022
Actual trial start date 10/01/2022
Anticipated date of last follow up 05/12/2022
Actual Last follow-up date 16/12/2022
Anticipated target sample size (number of participants) 2214
Actual target sample size (number of participants) 2214
Recruitment status 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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile Telephone Communication Voice and Text message reminders for scheduled ANC visits. Every two weeks 8months In the intervention arm, mobile telephone phone-based text, recorded and voice messages comprising of information about the usefulness of maternal health services’ such as ANC, PNC and institutional delivery; and reminders of their next scheduled ANC appointment will be sent. Particularly, every two weeks a text and voice message comprising of reminders for the next ANC visit, information about its importance of the first four ANC visits and expected date of delivery (EDD) will be sent to expectant mothers. 1107
Control Group Standard Maternal Health Care without any reminders Zero 8 months The control group will not receive any reminders for scheduled antenatal visits and any maternal health care information on their mobile telephones. The expectant mothers will receive the standard maternal healthcare as and when they present themselves to the health centres. 1107 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Gestational Age <= 10 Weeks 2. Possession of a Mobile Phone by mother or member of household 3. Willingness to participate 1.Gestation >10 weeks 2.Sickness 3. Unwillingness to participate Adult: 19 Year-44 Year 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 12/01/2022 Uganda National Council of Science and Technology
Ethics Committee Address
Street address City Postal code Country
Kampala Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of Antenatal Care Visits Attended End of the Pregnancy- after delivery
Secondary Outcome Number of Examinations received during pregnancy End of pregnancy/at delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rakai and Kyotera Districts in Uganda Kyoteara Kampala 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
The Regional Universities Forum for Capacity Building in Agriculture Wandegeya-Kampala Kampala 256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Regional Universities Forum for Capacity Building in Agriculture Wandegeya -Kampala Kampala 256 Uganda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maria Nakachwa nakachwam@gmail.com +256772927496 Kampala
City Postal code Country Position/Affiliation
Kampala 256 Uganda PhD Student Nkumba University Uganda
Role Name Email Phone Street address
Scientific Enquiries Miph Musoke musokemb@yahoo.com +256712997963 Kampala
City Postal code Country Position/Affiliation
Kampala 256 Uganda Senior Lecturer Nkumba University Uganda
Role Name Email Phone Street address
Public Enquiries Frank Pio Kiyingi kfrankpio@yahoo.com +256787934657 Kampala
City Postal code Country Position/Affiliation
Kampala 256 Uganda Senior Lecturer Nkumba University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I am Maria Nakachwa, a PhD student at Nkumba University conducting a Randomised Controlled Trial regarding Mobile Telephone Communication and Utilization of Antenatal Care Services among Expectant mothers of Rakai and Kyotera Districts in Uganda. I am willing to share my data during the course of the study and after. Results are currently unavailable since recruitment of study participants is still ongoing. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol February-June 2023 Files to be uploaded to the website
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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