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Trial registered on ANZCTR


Registration number
ACTRN12623000057684
Ethics application status
Approved
Date submitted
9/01/2023
Date registered
17/01/2023
Date last updated
19/10/2023
Date data sharing statement initially provided
17/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Interactive Voice Response (IVR) based health information for antenatal and postnatal care services in rural Bangladesh
Scientific title
The effect of Interactive Voice Response (IVR) based health information for antenatal and postnatal care services women of reproductive age group in rural Bangladesh on maternal and child health outcomes
Secondary ID [1] 304355 0
Laerdal Foundation - 40715
Universal Trial Number (UTN)
U1111-1268-9094
Trial acronym
IVRMCH (Interactive Voice Response for maternal and child health)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy complications 323328 0
Condition category
Condition code
Public Health 320891 320891 0 0
Health promotion/education
Reproductive Health and Childbirth 325705 325705 0 0
Antenatal care
Reproductive Health and Childbirth 325706 325706 0 0
Normal pregnancy
Reproductive Health and Childbirth 325707 325707 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of interventions using the TIDieR (Template for Intervention Description and Replication) Checklist

Brief name/description: This is an interactive voice response (IVR) based health information trial where pregnant women in rural Bangladesh will be provided with information on evidence-based and recommended World Health Organization (WHO) guidelines and the guidelines of Bangladesh following the Ministry of Health and Family Welfare for prenatal and postnatal care services for expectant mothers and their newborn babies.
Why?: Having evidence-based information on maternal and child care will improve maternal and child health outcomes in two ways:
- by improving in knowledge on and practice of maternal and child health care, and
- by improving maternal and child health care seeking
What:
Demonstration: One-hour session on how to access the information using IVR on a mobile phone.
Materials: 15 modules containing pregnancy and postpartum stage-specific information on antenatal and postnatal care, antenatal and postnatal mental health, and taking care of a newborn baby for up to 6 months.
The modules will be recorded in voice-over form and stored using IVR technology. Participants will be able to access this information any time they want.
Tele-health: In one of the intervention arms, tele-health support will be provided by a doctor for common health problems, at participant's own discretion. each call may last up to 15 minutes. This support will be provided for general health problems only where a doctor can provide support without physically examining pregnant women.
Arm 1: IVR + Tele-health – Participants will be able to interact with the messages system using the keypad of their phone and will be able to contact a project doctor to discuss their health and the heath of their babies once they are born.
Arm 2: IVR - Participants will be able to interact with the messages system using the keypad of their phone
Arm 3: Control – N intervention will be given.
Text: Participants will receive one push notification once every two weeks, to encourage them to access information.
Call: Participants will receive push call once every two weeks (following the text message stated above) to encourage them to access information.
Dose: Participants are expected to listen to each IVR module at least once to measure the effect. The duration of each module is about 15 minutes. Participants can listen to the modules as many time they want.
Procedure: Dissemination of maternal and child health information using mobile phone network and IVR.
Who provided:
Demonstration session will be observed by the project staff members who hold a bachelor's degree and have at least five years of experience working in maternal and child health and early childhood development. There will be a doctor to respond to the participants call or answer to their query over the phone in one of the intervention arms.
How:
Demonstration sessions will be conducted face-to-face. The modules will be recorded in voice-over form and stored using IVR technology. Participants will be able to access this information any time they want. Participants will receive push notification to encourage them to access information.
Where:
330 villages in the southwestern part of Bangladesh.
Arm 1: 110
Arm 2: 110
Arm 3: 110
When and how much:
Demonstration session: At the end of baseline 1 session
Modules: 15 modules stored and accessible using IVR
Text: 1 push notifications every two weeks (1 text followed by 1 call, for Arms 1 and 2)
Dose: Participants are expected to listen to each IVR module at least once (1 time) to measure the effect.
Help from doctors: Help from doctor will be available at specific time slots during the day in one of the treatment arms.
Tailoring:
The push notification will be tailored based on whether the participants are in antenatal or postpartum stages and the child’s age (in months).
Modification: N/A
How well:
Planned: Each time an IVR module will be accessed and listened to, the number will be automatically recorded.
Text messages will be sent by a team of project staff members who will be supervised by a team leader.
A senior project staff member will ensure whether IVR modules are accessible by keeping an update, using a log, of accessible modules.
Doctor: Doctor will be given a separate mobile phone with a dedicated number, with field-level monitoring in place.
Actual: If IVR was available to Arm 1 and 2, doctor was accessible via phone, push text and call were made

Intervention code [1] 321565 0
Prevention
Intervention code [2] 321566 0
Behaviour
Comparator / control treatment
The control group will not receive the intervention.
Control group
Active

Outcomes
Primary outcome [1] 329569 0
Antenatal Care (ANC) and Postnatal Care (PNC)practice (composite outcome)

1. Number of ANC visits to the doctor/ midwife
2. Number of PNC consultations with doctor/ midwife

Tool: study specific questionnaire about ANC and PNC visits at endline ,
Timepoint [1] 329569 0
at 6 months postpartum
Primary outcome [2] 329570 0
Maternal mental health and child caring learning (composite outcome)
1. Awareness about maternal mental health
2, Awareness about nutrition and immunisation of infants and babies

Tool: Study specific questionnaire
Timepoint [2] 329570 0
at 6 months postpartum
Primary outcome [3] 329571 0
Health-seeking behaviour from facilities- for mother and child:

1. visiting health facilities/ doctors or consulting doctor for health problems duirng pregnancy and postpartum (up to 6 months) (excluding ANC and PNC visits/ consultations)
2. visiting health facilities/ doctors or consulting doctor for health problems of the infant/ baby (within followup period) (excluding for immunisation)

Tool: Study specific questionnaire
Timepoint [3] 329571 0
6 months postpartum
Secondary outcome [1] 402919 0
events of 5 signs of pregnancy complications
Tool: Study-specific questionnaire
Timepoint [1] 402919 0
At delivery (+ 10 days as the mother may need time to recover and take care of the new baby)
Secondary outcome [2] 402920 0
Stillbirth
Tool: Patient medical record
Timepoint [2] 402920 0
at 6 months after delivery
Secondary outcome [3] 402921 0
the episode of common illnesses among babies
Tool: Study specific questionnaire
Timepoint [3] 402921 0
6 months of age
Secondary outcome [4] 402922 0
postnatal infection
Tool: study-specific questionnaire
Timepoint [4] 402922 0
at 10 days post-delivery
Secondary outcome [5] 403052 0
Preterm birth
Tool: Patient medical record
Timepoint [5] 403052 0
at 10 days post-delivery
Secondary outcome [6] 403053 0
Low birthweight
Tool: Patient medical record
Timepoint [6] 403053 0
at 10 days post-delivery
Secondary outcome [7] 403055 0
duration and number of times accessed IVR (composite outcome)
Tool: Platform analystics
Timepoint [7] 403055 0
6 months postpartum
Secondary outcome [8] 417532 0
Awareness of ANC and PNC - nutrition, rest, required ANC and PNC visits (composite outcome)
Tool: Study specific questionnaire
Timepoint [8] 417532 0
6 months after delivery

Eligibility
Key inclusion criteria
- 15 years old or older up to 49 years
- up to 24 weeks or within the 2nd trimester
- able to give informed consent
Minimum age
15 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- below 15 years of age and above 49 years
- not currently pregnant
- pregnant but in their third trimester
- not able to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation at village level. Participants will be recruited between 20 January - 20 March 2023. 8-18 participants will be recruited from each village.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Intention to treat (ITT)

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/01/2023
Actual
21/01/2023
Date of last participant enrolment
Anticipated
20/03/2023
Actual
31/03/2023
Date of last data collection
Anticipated
20/06/2024
Actual
Sample size
Target
3900
Accrual to date
Final
4107
Recruitment outside Australia
Country [1] 24321 0
Bangladesh
State/province [1] 24321 0
Khulna

Funding & Sponsors
Funding source category [1] 308724 0
Charities/Societies/Foundations
Name [1] 308724 0
Laerdal Foundation
Country [1] 308724 0
Norway
Funding source category [2] 310761 0
Other Collaborative groups
Name [2] 310761 0
Asian Development Bank
Country [2] 310761 0
Bangladesh
Primary sponsor type
University
Name
Monash University , Australia
Address
Centre for Development Economics and Sustainability (CDES)
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Country
Australia
Secondary sponsor category [1] 309623 0
None
Name [1] 309623 0
None
Address [1] 309623 0
None
Country [1] 309623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308647 0
Human Research Ethics Committee, Monash University, Australia
Ethics committee address [1] 308647 0
Ethics committee country [1] 308647 0
Australia
Date submitted for ethics approval [1] 308647 0
14/08/2021
Approval date [1] 308647 0
12/10/2021
Ethics approval number [1] 308647 0
29389

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111422 0
Prof Asadul Islam
Address 111422 0
Director, Centre for Development Economics and Sustainability (CDES)
Professor, Department of Economics
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Country 111422 0
Australia
Phone 111422 0
+61 3 990 32783
Fax 111422 0
+61 3 990 31128
Email 111422 0
asadul.islam@monash.edu
Contact person for public queries
Name 111423 0
Asadul Islam
Address 111423 0
Director, Centre for Development Economics and Sustainability (CDES)
Professor, Department of Economics
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Country 111423 0
Australia
Phone 111423 0
+61 3 990 32783
Fax 111423 0
+61 3 990 31128
Email 111423 0
asadul.islam@monash.edu
Contact person for scientific queries
Name 111424 0
Asadul Islam
Address 111424 0
Director, Centre for Development Economics and Sustainability (CDES)
Professor, Department of Economics
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Country 111424 0
Australia
Phone 111424 0
+61 3 990 32783
Fax 111424 0
+61 3 990 31128
Email 111424 0
asadul.islam@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The identified variables will be available upon submitting a request to the Chief Investigator.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14079Ethical approvalNo citation available. asadul.islam@monash.edu A copy of the pre-analysis plan has been uploaded ... [More Details] 382091-(Uploaded-12-11-2021-23-45-01)-Study-related document.pdf
20695Statistical analysis planAhmed, F., Islam A., Khalil U., Rahman, T., Suryadarma D. Improving Antenatal and Postnatal Care Delivery Services in Remote Communities using Telehealth: Pre-analysis plan. 2023. asadul.islam@monash.edu N/A 382091-(Uploaded-01-10-2023-18-24-42)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.